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2/29/2008
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Orthovita to Present at Susquehanna Financial Group’s SIGnificant Options in Healthcare
Conference
MALVERN, Pennsylvania, Friday, February 29, 2008 – Orthovita, Inc. (NASDAQ: VITA),
a spine and orthopedic biosurgery company, announced today that it will present
at Susquehanna Financial Group’s SIGnificant Options in Healthcare Conference
in New York. Albert J. Pavucek, Jr., chief financial officer of Orthovita,
is scheduled to present on Wednesday, March 5th, at 11:30 a.m. Eastern Time, at
The W Hotel, 541 Lexington Avenue, New York, NY. This presentation will not
be webcast.
About the Company
Orthovita is a spine and orthopedic biosurgery company with proprietary biomaterials
and biologic technologies for the development and commercialization of synthetic,
biologically active, tissue engineering products. We develop and market synthetic-based
biomaterials products for use in spine surgery, the repair of fractures and a broad
range of clinical needs in the trauma, joint reconstruction, revision and extremities
markets. Our near-term commercial business is based on our VITOSS(R) Bone
Graft Substitute technology platforms, which are designed to address the non-structural
bone graft market by offering synthetic alternatives to the use of autograft or
cadaver-based bone material, and VITAGEL(R) Surgical Hemostat, which is an adherent
matrix and an impermeable barrier to blood flow. Our longer-term U.S. clinical
development program is focused on our internally developed CORTOSS(R) Bone Augmentation
Material technology platform, which is primarily designed for injections in osteoporotic
spines to treat vertebral compression fractures. We work jointly with Kensey
Nash Corporation to develop and commercialize novel synthetic-based biomaterial
products, we market VITAGEL under a license granted by Angiotech Pharmaceuticals,
Inc., and we continue to pursue similar relationships with other companies in biomaterials.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s
current expectations of future events that involve risks and uncertainties, including,
without limitation, the development, regulatory approval, demand and market acceptance
of our products; our ability to obtain FDA clearance for CORTOSS in the United States;
and other aspects of our business. Such statements are based on management’s
current expectations and are subject to a number of substantial risks and uncertainties
that could cause actual results or timeliness to differ materially from those addressed
in the forward-looking statements. These risks and uncertainties include the risk
that the FDA will require the CORTOSS 510(k) application to contain two-year follow
up data for a greater percentage of the patients in the pivotal study than that
which is reflected in the application as originally filed with the FDA or for all
of the patients in the pivotal study. Other factors that may cause such a
difference are listed from time to time in reports filed by the Company with the
U.S. Securities and Exchange Commission (SEC), including but not limited to risks
described in our most recently filed Form 10-K under the caption "Risks Factors”.
Further information about these and other relevant risks and uncertainties may be
found in Orthovita’s filings with the SEC, all of which are available from the SEC
as well as other sources. Orthovita undertakes no obligation to publicly update
any forward-looking statements.
Source: Orthovita, Inc.
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2/28/2008
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Orthovita to Present at the Canaccord Adams Small-Cap Orthopedics Conference
MALVERN, Pennsylvania, Thursday, February 28, 2008 – Orthovita,
Inc. (NASDAQ: VITA), a spine and orthopedic biosurgery company, announced today
that it will present at the Canaccord Adams Small-Cap Orthopedics Conference in
San Francisco. Antony Koblish, president and chief executive officer of Orthovita,
is scheduled to present on Tuesday, March 4th, at 4:10 p.m. Pacific Time, at The
Mission Bay Conference Center at UCSF, 1675 Owens Street, San Francisco, CA.
A live audio-only webcast of the presentation will be available by visiting
http://www.newswire.ca/en/webcast/viewEvent.cgi?eventID=2186580.
About the Company
Orthovita is a spine and orthopedic biosurgery company with proprietary biomaterials
and biologic technologies for the development and commercialization of synthetic,
biologically active, tissue engineering products. We develop and market synthetic-based
biomaterials products for use in spine surgery, the repair of fractures and a broad
range of clinical needs in the trauma, joint reconstruction, revision and extremities
markets. Our near-term commercial business is based on our VITOSS? Bone Graft
Substitute technology platforms, which are designed to address the non-structural
bone graft market by offering synthetic alternatives to the use of autograft or
cadaver-based bone material, and VITAGEL? Surgical Hemostat, which is an adherent
matrix and an impermeable barrier to blood flow. Our longer-term U.S. clinical
development program is focused on our internally developed CORTOSS? Bone Augmentation
Material technology platform, which is primarily designed for injections in osteoporotic
spines to treat vertebral compression fractures. We work jointly with Kensey
Nash Corporation to develop and commercialize novel synthetic-based biomaterial
products, we market VITAGEL under a license granted by Angiotech Pharmaceuticals,
Inc., and we continue to pursue similar relationships with other companies in biomaterials.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s
current expectations of future events that involve risks and uncertainties, including,
without limitation, the development, regulatory approval, demand and market acceptance
of our products; our ability to obtain FDA clearance for CORTOSS in the United States;
and other aspects of our business. Such statements are based on management’s
current expectations and are subject to a number of substantial risks and uncertainties
that could cause actual results or timeliness to differ materially from those addressed
in the forward-looking statements. These risks and uncertainties include the risk
that the FDA will require the CORTOSS 510(k) application to contain two-year follow
up data for a greater percentage of the patients in the pivotal study than that
which is reflected in the application as originally filed with the FDA or for all
of the patients in the pivotal study. Other factors that may cause such a
difference are listed from time to time in reports filed by the Company with the
U.S. Securities and Exchange Commission (SEC), including but not limited to risks
described in our most recently filed Form 10-K under the caption "Risks Factors”.
Further information about these and other relevant risks and uncertainties may be
found in Orthovita’s filings with the SEC, all of which are available from the SEC
as well as other sources. Orthovita undertakes no obligation to publicly update
any forward-looking statements.
Source: Orthovita, Inc.
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2/26/2008
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VITOSS Podium and Electronic Poster Presentations at 2008 AANS/CNS Meeting
MALVERN, Pennsylvania, Tuesday, February 26, 2008 – Orthovita, Inc. (NASDAQ: VITA),
a spine and orthopedic biosurgery company, announced today an upcoming presentation
and electronic posters related to its VITOSS Bone Graft Substitute product.
These presentations will be held at the 2008 Annual Meeting of the American Association
of Neurological Surgeons/Congress of Neurological Surgeons (AANS/CNS), Section on
Disorders of the Spine and Peripheral Nerves, held in Orlando, Florida from February
27 through March 1, 2008. These presentations are based on research conducted
independently from Orthovita.
Oral Poster Presentation
Jeffrey McConnell, M.D., of the Pennsylvania Spine and Scoliosis Institute at OAA
Orthopaedic Specialists in Allentown, will give an oral poster presentation of an
abstract entitled, "A comparison of ß-TCP+BMA vs. RhBMP-2 in anterior lumbar
interbody fusion: A prospective, randomized trial with 1- year interim clinical
and radiographic outcomes."
“To my knowledge, our study represents the first direct randomized comparison between
VITOSS enriched with bone marrow aspirate and recombinant human bone morphogenic
protein in anterior lumbar fusion procedures,” said Dr. McConnell. “Our results
show no difference in radiological and clinical outcomes between the two groups.
The data from this study can help physicians choose the best bone graft composition
for an individual patient, taking both physiologic and economic factors into consideration.”
The podium presentation is scheduled for February 28, 2008, from 5:03 p.m. to 5:06
p.m. in Scientific Session II.
Poster Presentations
Neill Wright, M.D., Associate Professor in Neurological and Orthopaedic Surgery
at Washington University School of Medicine in St. Louis, will present two electronic
poster abstracts at the same meeting.
The first abstract is entitled "A Safer Method of Anterior Cervical Arthrodesis
Using rhBMP-2 in High-Risk Patients: Safety Profile and Fusion Outcomes in
50 Patients Treated with rhBMP-2 on a Beta-Tricalcium Phosphate Carrier."
The second abstract is entitled “Anterior Cervical Arthrodesis Without Autograft,
Allograft, or BMP-2: 75 Patients Treated with Beta-Tricalcium Phosphate Impregnated
with Local Bone Marrow Aspirate.”
Dr. Wright started his studies about two years ago. “We were not entirely
satisfied with allograft as a replacement for autograft, and thus were looking for
an alternative,” he said. “We specifically chose VITOSS for the osteoconductive
component of our graft because of its unique structure and high porosity.
In our studies, we have combined VITOSS with either bone marrow or BMP, and obtained
healing results that are at least comparable to those we obtained with autograft.”
About the Company
Orthovita is a spine and orthopedic biosurgery company with proprietary biomaterials
and biologic technologies for the development and commercialization of synthetic,
biologically active, tissue engineering products. We develop and market synthetic-based
biomaterials products for use in spine surgery, the repair of fractures and a broad
range of clinical needs in the trauma, joint reconstruction, revision and extremities
markets. Our near-term commercial business is based on our VITOSS(R) Bone
Graft Substitute technology platforms, which are designed to address the non-structural
bone graft market by offering synthetic alternatives to the use of autograft or
cadaver-based bone material, and VITAGEL(R) Surgical Hemostat, which is an adherent
matrix and an impermeable barrier to blood flow. Our longer-term U.S. clinical development
program is focused on our internally developed CORTOSS(R) Bone Augmentation Material
technology platform, which is primarily designed for injections in osteoporotic
spines to treat vertebral compression fractures. We work jointly with Kensey Nash
Corporation to develop and commercialize novel synthetic-based biomaterial products,
we market VITAGEL under a license granted by Angiotech Pharmaceuticals, Inc., and
we continue to pursue similar relationships with other companies in biomaterials.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s
current expectations of future events that involve risks and uncertainties, including,
without limitation, the development, regulatory approval, demand and market acceptance
of our products; our ability to obtain FDA clearance for CORTOSS in the United States;
and other aspects of our business. Such statements are based on management’s
current expectations and are subject to a number of substantial risks and uncertainties
that could cause actual results or timeliness to differ materially from those addressed
in the forward-looking statements. Other factors that may cause such a difference
are listed from time to time in reports filed by the Company with the U.S. Securities
and Exchange Commission (SEC), including but not limited to risks described in our
most recently filed Form 10-K under the caption "Risks Factors”. Further
information about these and other relevant risks and uncertainties may be found
in Orthovita’s filings with the SEC, all of which are available from the SEC as
well as other sources. Orthovita undertakes no obligation to publicly update any
forward-looking statements.
Source: Orthovita, Inc.
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2/20/2008
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CORTOSS® Podium Presentation at 2008 ASSR Meeting
MALVERN, Pennsylvania, Wednesday, February 20, 2008 – Orthovita, Inc. (NASDAQ: VITA),
a spine and orthopedic biosurgery company, today announced an upcoming podium presentation
related to its CORTOSS Bone Augmentation Material. The presentation will be
held at the 2008 Annual Meeting of the American Society of Spine Radiology held
in Indian Wells, California, from February 21 through 24, 2008.
Louis A. Gilula, M.D., Professor of Radiology and Orthopaedics at Washington University
School of Medicine in St. Louis, will present a paper entitled, “Fill Volumes in
Vertebroplasty: Observations in a Prospective Randomized IDE Study Comparing Cortoss
and PMMA.”
The presentation is based on the data of 68 patients treated and followed by Professor
Gilula and Dr. Paul Hatten of Vero Beach, Florida, as part of a larger 256-patient
Investigational Device Study conducted for regulatory submission by Orthovita to
the FDA for the use of CORTOSS in vertebral augmentation.
“Regarding clinical benefits, CORTOSS and polymethylmethacrylate performed equivalently.
Interestingly, we found that the volume of material that is needed to achieve those
clinical benefits for CORTOSS was half as much as for PMMA,” Professor Gilula said.
“The lower volume has the potential to reduce the incidence of pulmonary emboli,
which, although rare, are the most common adverse events seen in vertebroplasty
procedures.”
The podium presentation is scheduled for February 21, 2008, at 1:15 pm PT, in the
Crystal Ballroom D-F of the Renaissance Esmeralda Resort in Indian Wells.
About the Company
Orthovita is a spine and orthopedic biosurgery company with proprietary biomaterials
and biologic technologies for the development and commercialization of synthetic,
biologically active, tissue engineering products. We develop and market synthetic-based
biomaterials products for use in spine surgery, the repair of fractures and a broad
range of clinical needs in the trauma, joint reconstruction, revision and extremities
markets. Our near-term commercial business is based on our VITOSS® Bone Graft
Substitute technology platforms, which are designed to address the non-structural
bone graft market by offering synthetic alternatives to the use of autograft or
cadaver-based bone material, and VITAGEL® Surgical Hemostat, which is an adherent
matrix and an impermeable barrier to blood flow. Our longer-term U.S. clinical development
program is focused on our internally developed CORTOSS® Bone Augmentation Material
technology platform, which is primarily designed for injections in osteoporotic
spines to treat vertebral compression fractures. We work jointly with Kensey Nash
Corporation to develop and commercialize novel synthetic-based biomaterial products,
we market VITAGEL under a license granted by Angiotech Pharmaceuticals, Inc., and
we continue to pursue similar relationships with other companies in biomaterials.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s
current expectations of future events that involve risks and uncertainties, including,
without limitation, the development, regulatory approval, demand and market acceptance
of our products; our ability to obtain FDA clearance for CORTOSS in the United States;
and other aspects of our business. Such statements are based on management’s
current expectations and are subject to a number of substantial risks and uncertainties
that could cause actual results or timeliness to differ materially from those addressed
in the forward-looking statements. Other factors that may cause such a difference
are listed from time to time in reports filed by the Company with the U.S. Securities
and Exchange Commission (SEC), including but not limited to risks described in our
most recently filed Form 10-K under the caption "Risks Factors”. Further
information about these and other relevant risks and uncertainties may be found
in Orthovita’s filings with the SEC, all of which are available from the SEC as
well as other sources. Orthovita undertakes no obligation to publicly update any
forward-looking statements.
Source: Orthovita, Inc.
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1/23/2008
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Orthovita to Participate in the 2008 Wachovia Healthcare Conference
MALVERN, Pennsylvania, Wednesday, January 23, 2008 – Orthovita, Inc. (NASDAQ: VITA),
a spine and orthopedic biosurgery company, announced today that it will present
at the 2008 Wachovia Healthcare Conference in Boston. Antony Koblish, president
and chief executive officer of Orthovita, is scheduled to present on Thursday, January
31st, at 1:00 p.m. Eastern Time, at The Langham Hotel, 250 Franklin Street, Boston,
MA. A live audio webcast of the presentation will be available and can be
accessed for 90 days following the conference by visiting
http://www.wsw.com/webcast/wa48/vita.
About the Company
Orthovita is a spine and orthopedic biosurgery company with proprietary biomaterials
and biologic technologies for the development and commercialization of synthetic,
biologically active, tissue engineering products. We develop and market synthetic-based
biomaterials products for use in spine surgery, the repair of fractures and a broad
range of clinical needs in the trauma, joint reconstruction, revision and extremities
markets. Our near-term commercial business is based on our VITOSS(R) Bone
Graft Substitute technology platforms, which are designed to address the non-structural
bone graft market by offering synthetic alternatives to the use of autograft or
cadaver-based bone material, and VITAGEL(R) Surgical Hemostat, which is an adherent
matrix and an impermeable barrier to blood flow. Our longer-term U.S. clinical
development program is focused on our internally developed CORTOSS(R) Bone Augmentation
Material technology platform, which is primarily designed for injections in osteoporotic
spines to treat vertebral compression fractures. We work jointly with Kensey
Nash Corporation to develop and commercialize novel synthetic-based biomaterial
products, we market VITAGEL under a license granted by Angiotech Pharmaceuticals,
Inc., and we continue to pursue similar relationships with other companies in biomaterials.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s
current expectations of future events that involve risks and uncertainties, including,
without limitation, the development, regulatory approval, demand and market acceptance
of our products; our ability to obtain FDA clearance for CORTOSS in the United States;
and other aspects of our business. Such statements are based on management’s
current expectations and are subject to a number of substantial risks and uncertainties
that could cause actual results or timeliness to differ materially from those addressed
in the forward-looking statements. These risks and uncertainties include the risk
that the FDA will require the CORTOSS 510(k) application to contain two-year follow
up data for a greater percentage of the patients in the pivotal study than that
which is reflected in the application as originally filed with the FDA or for all
of the patients in the pivotal study. Other factors that may cause such a
difference are listed from time to time in reports filed by the Company with the
U.S. Securities and Exchange Commission (SEC), including but not limited to risks
described in our most recently filed Form 10-K under the caption "Risks Factors”.
Further information about these and other relevant risks and uncertainties may be
found in Orthovita’s filings with the SEC, all of which are available from the SEC
as well as other sources. Orthovita undertakes no obligation to publicly update
any forward-looking statements.
Source: Orthovita, Inc.
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1/15/2008
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Orthovita Submits 510(k) Application to FDA for the Use of CORTOSS® Bone Augmentation
Material in Vertebral Augmentation
MALVERN, Pennsylvania, Tuesday, January 15, 2008 – Orthovita, Inc. (NASDAQ: VITA),
a spine and orthopedic biosurgery company, announced today that it has submitted
a 510(k) filing to the U.S. Food and Drug Administration for the use of its CORTOSS
Bone Augmentation Material in vertebral augmentation. This filing is based
on data collected in three U.S. clinical investigations conducted under FDA Investigational
Device Exemptions (IDEs) and several European studies, and is intended to demonstrate
that the performance of CORTOSS is substantially equivalent to polymethylmethacrylate
(PMMA) bone cement. The extensive clinical study of CORTOSS demonstrates that
the same degree of clinical improvement in pain and function is achieved with approximately
40% less material than PMMA when augmenting the vertebral body. CORTOSS also
provides other benefits, including consistent handling characteristics and viscosity.
The CORTOSS 510(k) filing includes data on 469 vertebral compression fracture patients
treated with CORTOSS and 94 patients treated with PMMA with follow up ranging from
11 months to over 3 years. This data includes results from Orthovita’s pivotal,
prospective, randomized clinical study conducted under an FDA IDE. In the
pivotal study, a total of 162 patients were treated with CORTOSS and 94 patients
were treated with PMMA. Two-year follow up for all 256 of the pivotal study
patients will be completed in February 2009.
“The 510(k) filing is a key step toward the introduction of CORTOSS to the U.S.
market as an alternative to PMMA bone cement for the treatment of vertebral compression
fractures. To the Company’s knowledge, the CORTOSS 510(k) filing contains
the largest prospective, randomized, controlled clinical dataset ever assembled
in the treatment of vertebral compression fractures. We would like to express our
gratitude to all our investigators and their personnel for their hard work and invaluable
contributions that helped us achieve this milestone,” said Antony Koblish, President
and Chief Executive Officer of Orthovita.
FDA clearance of CORTOSS would permit Orthovita to market and sell the material
in the United States. CORTOSS has CE Certification for use in the European
Union for screw augmentation and for vertebral augmentation. This enables
CORTOSS to be sold in the European Union as well as in other countries that have
adopted the European Union’s regulatory standards.
About the Company
Orthovita is a spine and orthopedic biosurgery company with proprietary biomaterials
and biologic technologies for the development and commercialization of synthetic,
biologically active, tissue engineering products. We develop and market synthetic-based
biomaterials products for use in spine surgery, the repair of fractures and a broad
range of clinical needs in the trauma, joint reconstruction, revision and extremities
markets. Our near-term commercial business is based on our VITOSS(R) Bone
Graft Substitute technology platforms, which are designed to address the non-structural
bone graft market by offering synthetic alternatives to the use of autograft or
cadaver-based bone material, and VITAGEL(R) Surgical Hemostat, which is an adherent
matrix and an impermeable barrier to blood flow. Our longer-term U.S. clinical development
program is focused on our internally developed CORTOSS(R) Bone Augmentation Material
technology platform, which is primarily designed for injections in osteoporotic
spines to treat vertebral compression fractures. We work jointly with Kensey Nash
Corporation to develop and commercialize novel synthetic-based biomaterial products,
we market VITAGEL under a license granted by Angiotech Pharmaceuticals, Inc., and
we continue to pursue similar relationships with other companies in biomaterials.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s
current expectations of future events that involve risks and uncertainties, including,
without limitation, the development, regulatory approval, demand and market acceptance
of our products; our ability to obtain FDA clearance for CORTOSS in the United States;
and other aspects of our business. Such statements are based on management’s
current expectations and are subject to a number of substantial risks and uncertainties
that could cause actual results or timeliness to differ materially from those addressed
in the forward-looking statements. These risks and uncertainties include the risk
that the FDA will require the CORTOSS 510(k) application to contain two-year follow
up data for a greater percentage of the patients in the pivotal study than that
which is reflected in the application as originally filed with the FDA or for all
of the patients in the pivotal study. Other factors that may cause such a
difference are listed from time to time in reports filed by the Company with the
U.S. Securities and Exchange Commission (SEC), including but not limited to risks
described in our most recently filed Form 10-K under the caption "Risks Factors”.
Further information about these and other relevant risks and uncertainties may be
found in Orthovita’s filings with the SEC, all of which are available from the SEC
as well as other sources. Orthovita undertakes no obligation to publicly update
any forward-looking statements.
Source: Orthovita, Inc.
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1/2/2008
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Orthovita to Present at the 10th Annual Needham & Company, LLC Growth Conference
MALVERN, Pennsylvania, Wednesday, January 2, 2008 – Orthovita, Inc. (NASDAQ: VITA),
a spine and orthopedic biosurgery company, announced today that it will present
at the 10th Annual Needham & Company, LLC Growth Conference in New York.
Antony Koblish, president and chief executive officer of Orthovita, is scheduled
to present on Tuesday, January 8th, at 10:00 a.m. Eastern Time, at The New York
Palace Hotel, 455 Madison Avenue, New York, NY. An audio webcast of this presentation
will be available at http://www.wsw.com/webcast/needham21/vita
and will be archived at the same URL for 90 days following the conference.
About the Company
Orthovita is a spine and orthopedic biosurgery company with proprietary biomaterials
and biologic technologies for the development and commercialization of synthetic,
biologically active, tissue engineering products. We develop and market synthetic-based
biomaterials products for use in spine surgery, the repair of fractures and a broad
range of clinical needs in the trauma, joint reconstruction, revision and extremities
markets. Our near-term commercial business is based on our VITOSS(R) Bone
Graft Substitute technology platforms, which are designed to address the non-structural
bone graft market by offering synthetic alternatives to the use of autograft or
cadaver-based bone material, and VITAGEL(R) Surgical Hemostat, which is an adherent
matrix and an impermeable barrier to blood flow. Our longer-term U.S. clinical development
program is focused on our internally developed CORTOSS(R) Bone Augmentation Material
technology platform, which is primarily designed for injections in osteoporotic
spines to treat vertebral compression fractures. We work jointly with Kensey Nash
Corporation to develop and commercialize novel synthetic-based biomaterial products,
we market VITAGEL under a license granted by Angiotech Pharmaceuticals, Inc., and
we continue to pursue similar relationships with other companies in biomaterials.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s
current expectations of future events that involve risks and uncertainties, including,
without limitation, the development, regulatory approval, demand and market acceptance
of our products; the development of our sales network; the adequacy of inventory;
our ability to manufacture products; timing of any submissions to the FDA related
to CORTOSS approval; the adequacy of available resources; and other aspects of our
business. Such statements are based on management’s current expectations and
are subject to a number of substantial risks and uncertainties that could cause
actual results or timeliness to differ materially from those addressed in the forward-looking
statements. Factors that may cause such a difference are listed from time
to time in reports filed by the Company with the U.S. Securities and Exchange Commission
(SEC), including but not limited to risks described in our most recently filed Form
10-K under the caption "Risks Factors”. Further information about these
and other relevant risks and uncertainties may be found in Orthovita’s filings with
the SEC, all of which are available from the SEC as well as other sources. Orthovita
undertakes no obligation to publicly update any forward-looking statements.
Source: Orthovita, Inc.
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12/6/2007
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Orthovita to Participate in the RBC Capital Markets 2007 Healthcare Conference
MALVERN, Pennsylvania, Thursday, December 6, 2007 – Orthovita, Inc. (NASDAQ: VITA),
a spine and orthopedic biosurgery company, announced today that it will participate
in the RBC Capital Markets 2007 Healthcare Conference in New York. Antony
Koblish, president and chief executive officer of Orthovita, will participate in
a panel discussion entitled “Biomaterials: Helping the Body Regenerate Bone
& Tissue” on Thursday, December 13th, at 8:00 a.m. Eastern Time, at The Westin
New York at Times Square, 270 West 43rd Street, New York, NY. A live audio-only
webcast of the panel discussion will be available and can be accessed for thirty
days following the conference by visiting
http://www.wsw.com/webcast/rbc84/panel20.
About the Company
Orthovita is a spine and orthopedic biosurgery company with proprietary biomaterials
and biologic technologies for the development and commercialization of synthetic,
biologically active, tissue engineering products. We develop and market synthetic-based
biomaterials products for use in spine surgery, the repair of fractures and a broad
range of clinical needs in the trauma, joint reconstruction, revision and extremities
markets. Our near-term commercial business is based on our VITOSS(R) Bone
Graft Substitute technology platforms, which are designed to address the non-structural
bone graft market by offering synthetic alternatives to the use of autograft or
cadaver-based bone material, and VITAGEL(R) Surgical Hemostat, which is an adherent
matrix and an impermeable barrier to blood flow. Our longer-term U.S. clinical
development program is focused on our internally developed CORTOSS(R) Bone Augmentation
Material technology platform, which is primarily designed for injections in osteoporotic
spines to treat vertebral compression fractures. We work jointly with Kensey
Nash Corporation to develop and commercialize novel synthetic-based biomaterial
products, we market VITAGEL under a license granted by Angiotech Pharmaceuticals,
Inc., and we continue to pursue similar relationships with other companies in biomaterials.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s
current expectations of future events that involve risks and uncertainties, including,
without limitation, the development, regulatory approval, demand and market acceptance
of our products; the development of our sales network; the adequacy of inventory;
our ability to manufacture products; timing of any submissions to the FDA related
to CORTOSS approval; the adequacy of available resources; and other aspects of our
business. Such statements are based on management’s current expectations and
are subject to a number of substantial risks and uncertainties that could cause
actual results or timeliness to differ materially from those addressed in the forward-looking
statements. Factors that may cause such a difference are listed from time
to time in reports filed by the Company with the U.S. Securities and Exchange Commission
(SEC), including but not limited to risks described in our most recently filed Form
10-K under the caption "Risks Factors”. Further information about these
and other relevant risks and uncertainties may be found in Orthovita’s filings with
the SEC, all of which are available from the SEC as well as other sources. Orthovita
undertakes no obligation to publicly update any forward-looking statements.
Source: Orthovita, Inc.
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11/15/2007
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Orthovita to Conduct an Institutional Investor Meeting in Conjunction with Canaccord
Adams on November 30th in New York
MALVERN, Pennsylvania, November 15, 2007 – Orthovita, Inc. (NASDAQ: VITA), a spine
and orthopedic biosurgery company, announced today that it will conduct an institutional
investor meeting in conjunction with Canaccord Adams Inc. on Friday, November 30,
2007, in New York. Antony Koblish, President and Chief Executive Officer of
Orthovita, Albert J. Pavucek, Jr., Chief Financial Officer, and several members
of Orthovita’s management team will present at the meeting scheduled from 10:00
a.m. to 2:00 p.m. Eastern Standard Time, in the Fontainebleau Room of The St. Regis
Hotel, 2 East 55th Street at 5th Avenue, New York, NY. William J. Plovanic,
CFA, Managing Director of Equity Research at Canaccord Adams, will be co-hosting
the meeting.
In addition, the meeting will feature guest speaker Ben B. Pradhan, M.D., M.S.E.,
from Saint John’s Health Center in Santa Monica, CA, the second largest enrolling
site for Orthovita’s 256-patient CORTOSS® VCF clinical trial. Dr. Pradhan
is among the top three surgeons in the U.S. with clinical experience using CORTOSS.
About the Company
Orthovita is a spine and orthopedic biosurgery company with proprietary biomaterials
and biologic technologies for the development and commercialization of synthetic,
biologically active, tissue engineering products. We develop and market synthetic-based
biomaterials products for use in spine surgery, the repair of fractures and a broad
range of clinical needs in the trauma, joint reconstruction, revision and extremities
markets. Our near-term commercial business is based on our VITOSS® Bone Graft
Substitute technology platforms, which are designed to address the non-structural
bone graft market by offering synthetic alternatives to the use of autograft or
cadaver-based bone material, and VITAGEL® Surgical Hemostat, which is an adherent
matrix and an impermeable barrier to blood flow. Our longer-term U.S. clinical development
program is focused on our internally developed CORTOSS® Bone Augmentation Material
technology platform, which is primarily designed for injections in osteoporotic
spines to treat vertebral compression fractures. We work jointly with Kensey Nash
Corporation to develop and commercialize novel synthetic-based biomaterial products,
we market VITAGEL under a license granted by Angiotech Pharmaceuticals, Inc., and
we continue to pursue similar relationships with other companies in biomaterials.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s
current expectations of future events that involve risks and uncertainties, including,
without limitation, the development, regulatory approval, demand and market acceptance
of our products; the development of our sales network; the adequacy of inventory;
our ability to manufacture products; timing of any submissions to the FDA related
to CORTOSS approval; the adequacy of available resources; and other aspects of our
business. Such statements are based on management’s current expectations and
are subject to a number of substantial risks and uncertainties that could cause
actual results or timeliness to differ materially from those addressed in the forward-looking
statements. Factors that may cause such a difference are listed from time
to time in reports filed by the Company with the U.S. Securities and Exchange Commission
(SEC), including but not limited to risks described in our most recently filed Form
10-K under the caption "Risks Factors”. Further information about these
and other relevant risks and uncertainties may be found in Orthovita’s filings with
the SEC, all of which are available from the SEC as well as other sources. Orthovita
undertakes no obligation to publicly update any forward-looking statements.
Source: Orthovita, Inc.
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11/5/2007
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Orthovita Reports Third Quarter 2007 Financial
Results
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10/23/2007
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Orthovita Schedules Third Quarter 2007 Financial Results Conference Call
MALVERN, Pennsylvania, USA, Tuesday, October 23, 2007 – Orthovita, Inc. (NASDAQ:
VITA), a spine and biosurgery company, will hold a conference call on Tuesday, November
6, 2007, at 8:30 a.m. Eastern Time, to review and discuss its financial results
for the third quarter 2007. Antony Koblish, President and Chief Executive
Officer, and Albert J. Pavucek, Jr., Chief Financial Officer of Orthovita, will
host the call.
The phone number to join the conference call from within the U.S. is (888) 815-2919,
and from outside the U.S. is (706) 643-3675. The conference identification
number is 21618688. Participants should dial in ten minutes prior to the scheduled
start time for the conference call.
A replay of the conference call will be available for one week beginning November
6, 2007, at 11:30 a.m. Eastern Time, and ending November 13, 2007, at 11:59 p.m.
Eastern Time. You may listen to the replay by dialing within the U.S. (800)
642-1687 or by dialing from outside the U.S. (706) 645-9291. The replay identification
number is 21618688.
About the Company
Orthovita is a spine and orthopedic biosurgery company with proprietary biomaterials
and biologic technologies for the development and commercialization of synthetic,
biologically active, tissue engineering products. We develop and market synthetic-based
biomaterials products for use in spine surgery, the repair of fractures and a broad
range of clinical needs in the trauma, joint reconstruction, revision and extremities
markets. Our near-term commercial business is based on our VITOSS(R) Bone
Graft Substitute technology platforms, which are designed to address the non-structural
bone graft market by offering synthetic alternatives to the use of autograft or
cadaver-based bone material, and VITAGEL(R) Surgical Hemostat, which is an adherent
matrix and an impermeable barrier to blood flow. Our longer-term U.S. clinical development
program is focused on our internally developed CORTOSS(R) Bone Augmentation Material
technology platform, which is primarily designed for injections in osteoporotic
spines to treat vertebral compression fractures. We work jointly with Kensey Nash
Corporation to develop and commercialize synthetic-based biomaterial products, we
market VITAGEL under a license granted by Angiotech Pharmaceuticals, Inc., and we
continue to pursue similar relationships with other companies in biomaterials.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s
current expectations of future events that involve risks and uncertainties, including,
without limitation, the development, regulatory clearance or approval, demand and
market acceptance of our products, including CORTOSS; the development of our sales
network; and other aspects of our business. Such statements are based on management’s
current expectations and are subject to a number of substantial risks and uncertainties
that could cause actual results or timeliness to differ materially from those addressed
in the forward-looking statements. Factors that may cause such a difference
are listed from time to time in reports filed by the Company with the U.S. Securities
and Exchange Commission (SEC), including but not limited to risks described in our
most recently filed Form 10-K under the caption "Risks Factors”. Further
information about these and other relevant risks and uncertainties may be found
in Orthovita’s filings with the SEC, all of which are available from the SEC as
well as other sources. Orthovita undertakes no obligation to publicly update any
forward-looking statements.
Source: Orthovita, Inc.
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10/18/2007
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Orthovita and Allergan Sign Binding Term Sheet for Bovine Collagen Raw Material,
Equipment and Technology License
MALVERN Pennsylvania, October 18, 2007 – Orthovita, Inc. (NASDAQ: VITA), a spine
and orthopedic biosurgery company, announced today that it has entered into a binding
term sheet to acquire raw material, equipment and a technology license from Allergan,
Inc. and its affiliate Allergan Sales, LLC for an aggregate purchase price of approximately
$6.6 million in cash. Orthovita expects to make the purchase price payment
in a lump sum on or about October 31, 2008. The term sheet provides for a
definitive agreement to be entered into on or before November 1, 2007.
The raw material, equipment and license to be acquired from Allergan relate primarily
to the production of Orthovita’s VITAGEL® Surgical Hemostat product, which combines
the biomaterials bovine collagen and thrombin with the patient’s autologous plasma.
The term sheet provides that Allergan, which currently supplies collagen for VITAGEL,
will manufacture and supply specified quantities of collagen to Orthovita no later
than October 31, 2008. These quantities are in addition to collagen to be
supplied by Allergan to Orthovita under an existing supply arrangement. Additionally,
under the term sheet, Allergan agreed to sell Orthovita certain collagen production
and test equipment. Allergan also agreed to grant Orthovita a non-exclusive,
perpetual, royalty-free, irrevocable license to certain collagen production process
technology and know-how. The license rights are limited to certain uses, including
those related to the processing and production of collagen for surgical hemostats.
Antony Koblish, President and Chief Executive Officer of Orthovita, said, “This
transaction sets our company up for enhanced supply and manufacturing stability
of VITAGEL over the long-term by allowing us to have better control of a key product
component. In addition, acquiring the production equipment and license will
give us the opportunity to integrate a new technology platform and capability into
the company.”
About the Company
Orthovita is a spine and orthopedic biosurgery company with proprietary biomaterials
and biologic technologies for the development and commercialization of synthetic,
biologically active, tissue engineering products. We develop and market synthetic-based
biomaterials products for use in spine surgery, the repair of fractures and a broad
range of clinical needs in the trauma, joint reconstruction, revision and extremities
markets. Our near-term commercial business is based on our VITOSS(R) Bone
Graft Substitute technology platforms, which are designed to address the non-structural
bone graft market by offering synthetic alternatives to the use of autograft or
cadaver-based bone material, and VITAGEL(R) Surgical Hemostat, which is an adherent
matrix and an impermeable barrier to blood flow. Our longer-term U.S. clinical development
program is focused on our internally developed CORTOSS(R) Bone Augmentation Material
technology platform, which is primarily designed for injections in osteoporotic
spines to treat vertebral compression fractures. We work jointly with Kensey Nash
Corporation to develop and commercialize novel synthetic-based biomaterial products,
we market VITAGEL under a license granted by Angiotech Pharmaceuticals, Inc., and
we continue to pursue similar relationships with other companies in biomaterials.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s
current expectations of future events that involve risks and uncertainties, including,
without limitation, the development, regulatory approval, demand and market acceptance
of our products; the development of our sales network; the adequacy of inventory;
our ability to manufacture products; timing of any submissions to the FDA related
to CORTOSS approval; the approval by applicable regulatory authorities of any facility
that manufactures our products or their raw materials; the adequacy of available
resources; and other aspects of our business. Such statements are based on
management’s current expectations and are subject to a number of substantial risks
and uncertainties that could cause actual results or timeliness to differ materially
from those addressed in the forward-looking statements. Factors that may cause
such a difference are listed from time to time in reports filed by the Company with
the U.S. Securities and Exchange Commission (SEC), including but not limited to
risks described in our most recently filed Form 10-K under the caption "Risks
Factors”. Further information about these and other relevant risks and uncertainties
may be found in Orthovita’s filings with the SEC, all of which are available from
the SEC as well as other sources. Orthovita undertakes no obligation to publicly
update any forward-looking statements.
Source: Orthovita, Inc.
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9/17/2007
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Orthovita to Present at the 2007 UBS Global Life Sciences Conference in New York
MALVERN, Pennsylvania, Monday, September 17, 2007 – Orthovita, Inc. (NASDAQ: VITA),
a spine and orthopedic biosurgery company, announced today that it will present
at the 2007 UBS Global Life Sciences Conference in New York. Antony Koblish,
president and chief executive officer of Orthovita, is scheduled to present on Monday,
September 24th, at 11:00 a.m. Eastern Time, at the Grand Hyatt New York Hotel, 109
East 42nd Street, New York, NY. An audio webcast of the presentation will
be available three hours after the presentation until October 27, 2007, and may
be accessed by visiting the company’s website, www.orthovita.com,
and clicking on the conference link under the Press Releases section of the Investors
tab.
About the Company
Orthovita is a spine and orthopedic biosurgery company with proprietary biomaterials
and biologic technologies for the development and commercialization of synthetic,
biologically active, tissue engineering products. We develop and market synthetic-based
biomaterials products for use in spine surgery, the repair of fractures and a broad
range of clinical needs in the trauma, joint reconstruction, revision and extremities
markets. Our near-term commercial business is based on our VITOSS(R) Bone
Graft Substitute technology platforms, which are designed to address the non-structural
bone graft market by offering synthetic alternatives to the use of autograft or
cadaver-based bone material, and VITAGEL(R) Surgical Hemostat, which is an adherent
matrix and an impermeable barrier to blood flow. Our longer-term U.S. clinical
development program is focused on our internally developed CORTOSS(R) Bone Augmentation
Material technology platform, which is primarily designed for injections in osteoporotic
spines to treat vertebral compression fractures. We work jointly with Kensey
Nash Corporation to develop and commercialize novel synthetic-based biomaterial
products, we market VITAGEL under a license granted by Angiotech Pharmaceuticals,
Inc., and we continue to pursue similar relationships with other companies in biomaterials.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s
current expectations of future events that involve risks and uncertainties, including,
without limitation, the development, regulatory approval, demand and market acceptance
of our products; the development of our sales network; the adequacy of inventory;
our ability to manufacture products; timing of any submissions to the FDA related
to CORTOSS approval; the adequacy of available resources; and other aspects of our
business. Such statements are based on management’s current expectations and
are subject to a number of substantial risks and uncertainties that could cause
actual results or timeliness to differ materially from those addressed in the forward-looking
statements. Factors that may cause such a difference are listed from time
to time in reports filed by the Company with the U.S. Securities and Exchange Commission
(SEC), including but not limited to risks described in our most recently filed Form
10-K under the caption "Risks Factors”. Further information about these
and other relevant risks and uncertainties may be found in Orthovita’s filings with
the SEC, all of which are available from the SEC as well as other sources. Orthovita
undertakes no obligation to publicly update any forward-looking statements.
Source: Orthovita, Inc.
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9/11/2007
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Orthovita to Present at the ThinkEquity Partners 5th Annual Growth Conference
MALVERN, Pennsylvania, Tuesday, September 11, 2007 – Orthovita, Inc. (NASDAQ: VITA),
a spine and orthopedic biosurgery company, announced today that it will present
at the ThinkEquity Partners 5th Annual Growth Conference in San Francisco.
Antony Koblish, president and chief executive officer of Orthovita, is scheduled
to present on Wednesday, September 19th, at 9:30 a.m. Pacific Time, at the St. Regis
Hotel, 125 Third Street, San Francisco, CA. A live webcast of this presentation
will be available at the following link:
http://www.corporate-ir.net/ireye/conflobby.zhtml?ticker=vita&item_id=1645645.
A webcast replay will be available one hour after the presentation and will be archived
at the same URL for ninety (90) days following the conference.
About the Company
Orthovita is a spine and orthopedic biosurgery company with proprietary biomaterials
and biologic technologies for the development and commercialization of synthetic,
biologically active, tissue engineering products. We develop and market synthetic-based
biomaterials products for use in spine surgery, the repair of fractures and a broad
range of clinical needs in the trauma, joint reconstruction, revision and extremities
markets. Our near-term commercial business is based on our VITOSS(R) Bone
Graft Substitute technology platforms, which are designed to address the non-structural
bone graft market by offering synthetic alternatives to the use of autograft or
cadaver-based bone material, and VITAGEL(R) Surgical Hemostat, which is an adherent
matrix and an impermeable barrier to blood flow. Our longer-term U.S. clinical
development program is focused on our internally developed CORTOSS(R) Bone Augmentation
Material technology platform, which is primarily designed for injections in osteoporotic
spines to treat vertebral compression fractures. We work jointly with Kensey
Nash Corporation to develop and commercialize novel synthetic-based biomaterial
products, we market VITAGEL under a license granted by Angiotech Pharmaceuticals,
Inc., and we continue to pursue similar relationships with other companies in biomaterials.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s
current expectations of future events that involve risks and uncertainties, including,
without limitation, the development, regulatory approval, demand and market acceptance
of our products; the development of our sales network; the adequacy of inventory;
our ability to manufacture products; timing of any submissions to the FDA related
to CORTOSS approval; the adequacy of available resources; and other aspects of our
business. Such statements are based on management’s current expectations and
are subject to a number of substantial risks and uncertainties that could cause
actual results or timeliness to differ materially from those addressed in the forward-looking
statements. Factors that may cause such a difference are listed from time
to time in reports filed by the Company with the U.S. Securities and Exchange Commission
(SEC), including but not limited to risks described in our most recently filed Form
10-K under the caption "Risks Factors”. Further information about these
and other relevant risks and uncertainties may be found in Orthovita’s filings with
the SEC, all of which are available from the SEC as well as other sources. Orthovita
undertakes no obligation to publicly update any forward-looking statements.
Source: Orthovita, Inc.
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9/10/2007
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Orthovita in Conjunction with Canaccord Adams will Conduct an Institutional Investors
Meeting on Friday, September 14th, in Boston
MALVERN, Pennsylvania, September 10, 2007 – Orthovita, Inc. (NASDAQ: VITA), a spine
and orthopedic biosurgery company, announced today that it will conduct an institutional
investor meeting in conjunction with Canaccord Adams Inc. on Friday, September 14,
2007 in Boston, MA. Antony Koblish, President and Chief Executive Officer
of Orthovita, Albert J. Pavucek, Jr., Chief Financial Officer, and several members
of Orthovita’s management team will present at the meeting scheduled from 10:00
a.m. to 2:00 p.m. Eastern Standard Time, in the Griffin/Robinson Room of The InterContinental
Hotel, 510 Atlantic Avenue, Boston, MA. William J. Plovanic, CFA, managing
director, equity research from Canaccord Adams will be co-hosting the meeting.
In addition, the meeting will feature guest speaker H. Paul Hatten, Jr., M.D., from
Indian River Radiology of Vero Beach, Florida, who will give a presentation entitled
“Treatment of Osteoporotic VCF with CORTOSS®: Preliminary Results and Biomechanical
Considerations from the First Prospective Trial at a Single Institution”, at approximately
11:00 a.m. Eastern Standard Time and will cover part of a prospective randomized
controlled study being conducted under an FDA Investigational Device Exemption (IDE).
The study assesses the safety and efficacy of Orthovita’s CORTOSS compared to commercially
available PMMA bone cements in osteoporotic compression fractures of the vertebra(e).
A total of 256 patients have been enrolled at 19 sites using a 2:1 randomization
with 162 patients assigned to CORTOSS and 94 patients assigned to PMMA. Dr.
Hatten is one of the 19 clinical sites involved in the FDA Investigational Device
Exemption (IDE) study and will cover part of a prospective randomized controlled
study being conducted under an FDA IDE study. At the Indian River Radiology
site, 57 patients have been enrolled; 36 treated using CORTOSS and 21 treated using
PMMA bone cement.
About the Company
Orthovita is a spine and orthopedic biosurgery company with proprietary biomaterials
and biologic technologies for the development and commercialization of synthetic,
biologically active, tissue engineering products. We develop and market synthetic-based
biomaterials products for use in spine surgery, the repair of fractures and a broad
range of clinical needs in the trauma, joint reconstruction, revision and extremities
markets. Our near-term commercial business is based on our VITOSS(R) Bone
Graft Substitute technology platforms, which are designed to address the non-structural
bone graft market by offering synthetic alternatives to the use of autograft or
cadaver-based bone material, and VITAGEL(R) Surgical Hemostat, which is an adherent
matrix and an impermeable barrier to blood flow. Our longer-term U.S. clinical development
program is focused on our internally developed CORTOSS(R) Bone Augmentation Material
technology platform, which is primarily designed for injections in osteoporotic
spines to treat vertebral compression fractures. We work jointly with Kensey Nash
Corporation to develop and commercialize novel synthetic-based biomaterial products,
we market VITAGEL under a license granted by Angiotech Pharmaceuticals, Inc., and
we continue to pursue similar relationships with other companies in biomaterials.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s
current expectations of future events that involve risks and uncertainties, including,
without limitation, the development, regulatory approval, demand and market acceptance
of our products; the development of our sales network; the adequacy of inventory;
our ability to manufacture products; timing of any submissions to the FDA related
to CORTOSS approval; the adequacy of available resources; and other aspects of our
business. Such statements are based on management’s current expectations and
are subject to a number of substantial risks and uncertainties that could cause
actual results or timeliness to differ materially from those addressed in the forward-looking
statements. Factors that may cause such a difference are listed from time
to time in reports filed by the Company with the U.S. Securities and Exchange Commission
(SEC), including but not limited to risks described in our most recently filed Form
10-K under the caption "Risks Factors”. Further information about these
and other relevant risks and uncertainties may be found in Orthovita’s filings with
the SEC, all of which are available from the SEC as well as other sources. Orthovita
undertakes no obligation to publicly update any forward-looking statements.
Source: Orthovita, Inc.
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9/7/2007
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Orthovita to Present at the First Albany Capital Regenerative Technologies Conference
in New York
MALVERN, Pennsylvania, Friday, September 7, 2007 – Orthovita, Inc. (NASDAQ: VITA),
a spine and orthopedic biosurgery company, announced today that it will present
at the First Albany Capital Regenerative Technologies Conference to be held at the
Yale Club, 50 Vanderbilt Avenue in New York. Antony Koblish, President and
Chief Executive Officer of Orthovita, is scheduled to present on Tuesday, September
11th, at 8:20 a.m. Eastern Time.
About the Company
Orthovita is a spine and orthopedic biosurgery company with proprietary biomaterials
and biologic technologies for the development and commercialization of synthetic,
biologically active, tissue engineering products. We develop and market synthetic-based
biomaterials products for use in spine surgery, the repair of fractures and a broad
range of clinical needs in the trauma, joint reconstruction, revision and extremities
markets. Our near-term commercial business is based on our VITOSS(R) Bone
Graft Substitute technology platforms, which are designed to address the non-structural
bone graft market by offering synthetic alternatives to the use of autograft or
cadaver-based bone material, and VITAGEL(R) Surgical Hemostat, which is an adherent
matrix and an impermeable barrier to blood flow. Our longer-term U.S. clinical
development program is focused on our internally developed CORTOSS(R) Bone Augmentation
Material technology platform, which is primarily designed for injections in osteoporotic
spines to treat vertebral compression fractures. We work jointly with Kensey
Nash Corporation to develop and commercialize novel synthetic-based biomaterial
products, we market VITAGEL under a license granted by Angiotech Pharmaceuticals,
Inc., and we continue to pursue similar relationships with other companies in biomaterials.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s
current expectations of future events that involve risks and uncertainties, including,
without limitation, the development, regulatory approval, demand and market acceptance
of our products; the development of our sales network; the adequacy of inventory;
our ability to manufacture products; timing of any submissions to the FDA related
to CORTOSS approval; the adequacy of available resources; and other aspects of our
business. Such statements are based on management’s current expectations and
are subject to a number of substantial risks and uncertainties that could cause
actual results or timeliness to differ materially from those addressed in the forward-looking
statements. Factors that may cause such a difference are listed from time
to time in reports filed by the Company with the U.S. Securities and Exchange Commission
(SEC), including but not limited to risks described in our most recently filed Form
10-K under the caption "Risks Factors”. Further information about these
and other relevant risks and uncertainties may be found in Orthovita’s filings with
the SEC, all of which are available from the SEC as well as other sources. Orthovita
undertakes no obligation to publicly update any forward-looking statements.
Source: Orthovita, Inc
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9/4/2007
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Orthovita Receives Frost & Sullivan's 2007 United States Growth Strategy Leadership
Award
MALVERN, Pennsylvania, USA, September 4, 2007 - Orthovita, Inc. (NASDAQ: VITA),
a spine and orthopedic biosurgery company, announced today that it received Frost
& Sullivan’s 2007 Growth Strategy Leadership Award in the U.S. Bone Graft Substitute
Market.
The Frost & Sullivan award is presented to the company that has strengthened
its position in its chosen field and whose strategy will have a lasting impact in
that market. This recognition is based on primary and secondary research focusing
on revenue growth, technological innovation and implementation of sales development
strategy.
"Over the years, Orthovita has demonstrated an ascending market share trend,
capturing about 35 percent of the market share in the competitive bone graft substitutes
market,” reported Frost & Sullivan analyst Aarti Shetty.
Orthovita introduced VITOSS®, its proprietary bone graft product, to the U.S. at
the 2001 American Academy of Orthopedic Surgeons (AAOS) annual conference. Made
of beta-tricalcium phosphate, VITOSS is a fully synthetic scaffold matrix designed
to mimic the porosity and structure of human cancellous bone. When mixed with the
patient’s own bone marrow, the implant contains the key components of a patient’s
own bone without the morbidity associated with harvesting graft from the patient
or using human donor tissue.
“This award is further validation of VITOSS’ leadership position in the ever more
crowded bone grafting market,” said Christopher Smith, Orthovita’s Senior Vice President
of U.S. Sales. “Orthovita’s focus on scientific research, innovation, clinical outcomes
and customer education has been and will continue to be the driving force behind
our sustained growth.”
About the Company
Orthovita is a spine and orthopedic biosurgery company with proprietary biomaterials
and biologic technologies for the development and commercialization of synthetic,
biologically active, tissue engineering products. We develop and market synthetic-based
biomaterials products for use in spine surgery, the repair of fractures and a broad
range of clinical needs in the trauma, joint reconstruction, revision and extremities
markets. Our near-term commercial business is based on our VITOSS(R) Bone
Graft Substitute technology platforms, which are designed to address the non-structural
bone graft market by offering synthetic alternatives to the use of autograft or
cadaver-based bone material, and VITAGEL(R) Surgical Hemostat, which is an adherent
matrix and an impermeable barrier to blood flow. Our longer-term U.S. clinical development
program is focused on our internally developed CORTOSS(R) Bone Augmentation Material
technology platform, which is primarily designed for injections in osteoporotic
spines to treat vertebral compression fractures. We work jointly with Kensey Nash
Corporation to develop and commercialize synthetic-based biomaterial products, we
market VITAGEL under a license granted by Angiotech Pharmaceuticals, Inc., and we
continue to pursue similar relationships with other companies in biomaterials.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s
current expectations of future events that involve risks and uncertainties, including,
without limitation, the development, regulatory clearance or approval, demand and
market acceptance of our products, including CORTOSS; the continued growth of our
products, including VITOSS; and other aspects of our business. Such statements
are based on management’s current expectations and are subject to a number of substantial
risks and uncertainties that could cause actual results or timeliness to differ
materially from those addressed in the forward-looking statements. Factors
that may cause such a difference are listed from time to time in reports filed by
the Company with the U.S. Securities and Exchange Commission (SEC), including but
not limited to risks described in our most recently filed Form 10-K under the caption
"Risks Factors”. Further information about these and other relevant risks
and uncertainties may be found in Orthovita’s filings with the SEC, all of which
are available from the SEC as well as other sources. Orthovita undertakes no obligation
to publicly update any forward-looking statements.
Source: Orthovita, Inc.
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8/7/2007
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Orthovita Reports 2007 Second Quarter Financial Results
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8/6/2007
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Orthovita Receives CE Mark for VITAGEL® Surgical Hemostat and CELLPAKER® Plasma
Collection System
MALVERN, Pennsylvania, USA, August 6, 2007 – Orthovita, Inc. (NASDAQ: VITA), a spine
and orthopedic biosurgery company, reported that it has received CE Mark approval
for its VITAGEL® Surgical Hemostat product and CELLPAKER® plasma collection system.
The approval allows Orthovita to market VITAGEL as a surgical hemostat in Europe.
VITAGEL is a composite liquid hemostat used in surgical procedures as an adjunct
to hemostasis when control of bleeding by ligature or conventional procedures is
ineffective or impractical. The CELLPAKER plasma collection system is used
in conjunction with Orthovita’s VITAGEL Surgical Hemostat product. VITAGEL
stimulates hemostasis and healing through multiple mechanisms, amplifying the patient’s
own biology. Upon application, VITAGEL works by combining a collagen/thrombin
suspension with the patient’s own plasma. The resultant fibrin/collagen clot
stems bleeding and provides a robust three-dimensional matrix for soft tissue healing.
“We believe that VITAGEL is the only surgical hemostat using collagen and thrombin
pre-blended directly into the product that is currently approved for use in Europe.
We are pleased to be able to offer this product to our European customers and plan
to launch VITAGEL in the European marketplace this September,” said Antony Koblish,
President and Chief Executive Officer of Orthovita.
About the Company
Orthovita is a spine and orthopedic biosurgery company with proprietary biomaterials
and biologic technologies for the development and commercialization of synthetic,
biologically active, tissue engineering products. We develop and market synthetic-based
biomaterials products for use in spine surgery, the repair of fractures and a broad
range of clinical needs in the trauma, joint reconstruction, revision and extremities
markets. Our near-term commercial business is based on our VITOSS? Bone Graft
Substitute technology platforms, which are designed to address the non-structural
bone graft market by offering synthetic alternatives to the use of autograft or
cadaver-based bone material, and VITAGEL Surgical Hemostat. Our longer-term U.S.
clinical development program is focused on our internally developed CORTOSS? Bone
Augmentation Material technology platform, which is primarily designed for injections
in osteoporotic spines to treat vertebral compression fractures. We work jointly
with Kensey Nash Corporation to develop and commercialize synthetic-based biomaterial
products, we market VITAGEL under a license granted by Angiotech Pharmaceuticals
(US), Inc., and we continue to pursue similar relationships with other biomaterials
companies.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s
current expectations of future events that involve risks and uncertainties, including,
without limitation, the development, regulatory approval, demand and market acceptance
of our products, including CORTOSS; the demand and market acceptance of VITAGEL
in the European market; the timing of any submissions to the FDA related to CORTOSS
approval; and other aspects of our business. Such statements are based on management’s
current expectations and are subject to a number of substantial risks and uncertainties
that could cause actual results or timeliness to differ materially from those addressed
in the forward-looking statements. Factors that may cause such a difference
are listed from time to time in reports filed by the Company with the U.S. Securities
and Exchange Commission (SEC), including but not limited to risks described in our
most recently filed Form 10-K under the caption "Risk Factors”. Further
information about these and other relevant risks and uncertainties may be found
in Orthovita’s filings with the SEC, all of which are available from the SEC as
well as other sources. Orthovita undertakes no obligation to publicly update any
forward-looking statements.
Source: Orthovita, Inc.
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8/2/2007
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Orthovita to Present at the Canaccord Adams 27th Annual Growth Conference
MALVERN, Pennsylvania, Thursday, August 2, 2007 – Orthovita, Inc. (NASDAQ: VITA),
a spine and orthopedic biosurgery company, announced today that it will present
at the Canaccord Adams 27th Annual Global Growth Conference in Boston. Antony
Koblish, president and chief executive officer of Orthovita, is scheduled to present
on Wednesday, August 8th, at 1:00 p.m. Eastern Time, at the InterContinental Boston
Hotel, 510 Atlantic Avenue, Boston, MA. A live webcast of this presentation
will be available at the following link:
http://www.corporate-ir.net/ireye/conflobby.zhtml?ticker=VITA&item_id=1609835.
A webcast replay will be available one hour after the presentation and will be archived
at the same URL for one year following the conference.
About the Company
Orthovita is a spine and orthopedic biosurgery company with proprietary biomaterials
and biologic technologies for the development and commercialization of synthetic,
biologically active, tissue engineering products. We develop and market synthetic-based
biomaterials products for use in spine surgery, the repair of fractures and a broad
range of clinical needs in the trauma, joint reconstruction, revision and extremities
markets. Our near-term commercial business is based on our VITOSS(R) Bone
Graft Substitute technology platforms, which are designed to address the non-structural
bone graft market by offering synthetic alternatives to the use of autograft or
cadaver-based bone material, and VITAGEL(R) Surgical Hemostat, which is an adherent
matrix and an impermeable barrier to blood flow. Our longer-term U.S. clinical
development program is focused on our internally developed CORTOSS(R) Bone Augmentation
Material technology platform, which is primarily designed for injections in osteoporotic
spines to treat vertebral compression fractures. We work jointly with Kensey
Nash Corporation to develop and commercialize novel synthetic-based biomaterial
products, we market VITAGEL under a license granted by Angiotech Pharmaceuticals,
Inc., and we continue to pursue similar relationships with other companies in biomaterials.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s
current expectations of future events that involve risks and uncertainties, including,
without limitation, the development, regulatory approval, demand and market acceptance
of our products; the development of our sales network; the adequacy of inventory;
our ability to manufacture products; timing of any submissions to the FDA related
to CORTOSS approval; the adequacy of available resources; and other aspects of our
business. Such statements are based on management’s current expectations and
are subject to a number of substantial risks and uncertainties that could cause
actual results or timeliness to differ materially from those addressed in the forward-looking
statements. Factors that may cause such a difference are listed from time
to time in reports filed by the Company with the U.S. Securities and Exchange Commission
(SEC), including but not limited to risks described in our most recently filed Form
10-K under the caption "Risks Factors”. Further information about these
and other relevant risks and uncertainties may be found in Orthovita’s filings with
the SEC, all of which are available from the SEC as well as other sources. Orthovita
undertakes no obligation to publicly update any forward-looking statements.
Source: Orthovita, Inc.
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7/30/2007
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Orthovita Announces $32.5 Million Equity Offering, $45 Million Debt Facility, and
Repurchase of Revenue Interest Obligation
Transactions position Orthovita to complete late-stage development program for CORTOSS®
and expand manufacturing, sales and marketing capabilities to pursue broader commercial
opportunities in spine and orthopedic biosurgery markets.
- - -
R. Scott Barry, Paul Thomas and William Tidmore join Orthovita Board of Directors
MALVERN, Pennsylvania, USA, July 30, 2007 – Orthovita, Inc. (NASDAQ: VITA), a spine
and orthopedic biosurgery company, announced today a $32.5 million equity offering.
The transaction consists of a registered direct offering of approximately 12.3 million
shares of Orthovita common stock to select institutional investors and an accredited
investor associated with one of the institutions. The share price is based
on a 15% discount to the 30 day volume weighted average price (VWAP) of the Company’s
common stock immediately prior to the date of the definitive offering documents.
The Company expects to receive approximately $32.2 million in net proceeds from
the equity offering after deduction of estimated offering expenses. There
is no placement agent in this transaction. Essex Woodlands Health Ventures
(EWHV) is the lead investor in this offering and will obtain the right to appoint
a member to the Orthovita Board of Directors. Lehman Brothers Inc., Magnetar
Capital, and affiliates of William Harris Investors, Inc., existing shareholders
of the Company, are the other institutional investors in the equity offering. The
Company intends to use the net proceeds from the equity offering for product development,
sales force expansion, increasing manufacturing capacity, as well as for working
capital and other general corporate purposes.
All of the shares of common stock are being offered by Orthovita pursuant to effective
registration statements previously filed with the SEC.
“This very significant financing, involving some of the leading investors in the
life sciences industry, positions Orthovita to complete the commercial development
effort for our product candidate CORTOSS® and to maximize the long-term sales opportunities
tied to our currently marketed products VITOSS® and VITAGEL®,” said Antony
Koblish, President and CEO of Orthovita. “This substantial investment validates
the continuing strength of our product line and the promising progress in our efforts
to develop and commercialize innovative new products for spine, orthopedic and biosurgery
fields in the years ahead.”
In a separate transaction, Orthovita announced that it is repurchasing from a securitization
vehicle arranged by Paul Capital Healthcare (formerly Paul Royalty Fund, L.P.) a
revenue interest on future sales of certain Orthovita products, including VITOSS®,
CORTOSS® and certain spinal structural devices. The Company entered into the
revenue interest agreement with Paul Capital Healthcare in October 2001 to fund
clinical development and marketing programs for its products. The terms of the 2001
agreement applied to sales of certain products in North America and Europe through
2016, and the revenue interest obligation will terminate upon the closing of the
repurchase transaction. The repurchase price for the revenue interest obligation
consists of a payment of $20 million in cash and approximately 1.14 million unregistered
shares of the Company’s common stock. Under the terms of the revenue interest repurchase
agreement, the Company has agreed to file with the SEC a Form S-3 to register the
resale of the shares issued as partial consideration for the repurchase of the revenue
interest obligation. Paul Capital Healthcare has indicated to the Company that it
expects to continue to maintain its existing equity position in Orthovita as part
of its long-term commitment to the Company.
The Company also announced that it has entered into a $45 million senior secured
note purchase facility with LB I Group Inc., an affiliate of Lehman Brothers Inc.
Notes issued under the facility will bear annual interest at 10% and will be due
in 2012. The Company initially will issue $25 million of its 10% senior secured
notes due 2012 under the facility. The notes will be sold to LB I Group Inc.
in a private placement transaction exempt from registration under the Securities
Act of 1933. Proceeds from the initial $25 million principal amount note issuance
will be used to (i) pay to the Paul Capital Healthcare securitization vehicle the
$20 million cash portion of the revenue interest obligation repurchase price; and
(ii) pay off approximately $2 million of outstanding indebtedness under capital
lease obligations. The Company expects to use the remaining proceeds from
the initial note issuance to fund continued expansion of manufacturing capacity
to meet anticipated commercial demand for Orthovita products. Under the debt
facility, if certain conditions are met, the Company has the option through January
30, 2010 to issue up to an additional $20 million aggregate principal amount of
10% senior secured notes due 2012 to fund working capital and other general business
purposes, including product acquisitions, sales force expansion and product development.
In connection with its entry into the facility, the Company will issue to the note
purchaser five-year warrants to purchase approximately 1.47 million shares of the
Company’s common stock at an exercise price of $3.41 per share, of which warrants
to purchase approximately 0.73 million shares will be exerciseable currently.
The unexerciseable warrants shall become exerciseable ratably upon future issuances
of the 10% senior secured notes under the facility. Under the debt facility agreement
with the note purchaser, the Company agreed to file with the SEC a registration
statement on Form S-3 in order to register the resale of the shares underlying the
warrants.
“With a $32.5 million equity transaction, a $45 million debt facility, and the termination
of our revenue interest obligation, Orthovita will have in place an unprecedented
level of financial resources to maximize the growth potential of our product line
and our existing pipeline. Upon the closing of these transactions, we will
be well positioned to complete all elements of our current strategy,” added Albert
J. Pavucek, Jr., CFO of Orthovita.
Orthovita also announced that three seasoned professionals with outstanding investment
and orthopedics manufacturing and marketing experience are joining its Board of
Directors. R. Scott Barry will be appointed to Orthovita’s Board in connection
with the closing of the equity offering on July 30, 2007, and Paul Thomas and William
Tidmore were appointed to Orthovita’s Board on July 27, 2007. Mr. Barry
is being appointed as a designee of Essex Woodlands Health Ventures. The three
new directors replace Joseph Harris, Robert Levande and Russell Whitman, who resigned
from Orthovita’s Board during July 2007.
R. Scott Barry is a Principal of Essex Woodlands Health Ventures, a healthcare venture
capital firm. Prior to joining Essex Woodlands, Mr. Barry held various roles
at Novartis Pharmaceuticals Corp. in the mergers & acquisitions and business
development & licensing groups, most recently as Global Head of Pharma Mergers
& Acquisitions. Prior to joining Novartis, Mr. Barry was a Director for
Century Capital Associates LLC, a boutique healthcare investment bank and consulting
firm. Mr. Barry also held positions at KPMG LLP in its healthcare corporate
finance group and assurance service group. Mr. Barry holds a Bachelor of Arts
degree from Wesleyan University and a M.B.A. degree from the Stern School of Business
at New York University.
“We are excited about our investment in the Company. We see Orthovita as a
leading ortho-biologic company and, in Essex’s view, these events are transformational
in positioning the Company for the next stage of its evolution,” said Mr. Barry.
Paul Thomas is the Chief Executive Officer and Chairman of the Board of LifeCell
Corporation (NASDAQ: LIFC), which develops and markets innovative tissue repair
products for use in reconstructive, orthopedic and urogynecologic surgical procedures.
Prior to joining LifeCell, Mr. Thomas was President of the Pharmaceutical Products
Division of Ohmeda Inc., a world leader in inhalation anesthetics and acute care
pharmaceuticals. He was responsible for the overall operations of Ohmeda’s
Pharmaceutical Division, which had worldwide sales of approximately $200 million
in 1997. Mr. Thomas received a M.B.A. degree, with an emphasis in marketing
and finance, from Columbia University Graduate School of Business, and completed
his postgraduate studies in chemistry at the University of Georgia Graduate School
of Arts and Science. He received his Bachelor of Science degree in chemistry
from St. Michael’s College in Vermont, where he graduated Cum Laude.
William Tidmore is the past President and Chairman of DePuy Acromed. He was
also President of DePuy, the world's oldest orthopedic company, which was acquired
by Johnson & Johnson in 1999. Over 14 years at DePuy, Mr. Tidmore held
various senior management positions including responsibilities for international
businesses with direct operational responsibilities in several countries across
Europe, Latin America, Japan, and Canada. He was instrumental in the acquisition
of Acromed by DePuy. Prior to that, Mr. Tidmore was at Ethicon, Inc., a J&J
company, where he held several management responsibilities, including Vice President
of Sales and Marketing in Canada. Mr. Tidmore holds a Marketing degree from
the University of Georgia.
David Fitzgerald, Chairman of the Orthovita Board of Directors, said, “The Company
is grateful for the service of our three former Board members and appreciates their
contributions. As we plan for the multiple development and commercial opportunities
ahead at Orthovita, we also welcome our three new Board members who bring us many
important new perspectives and capabilities related to the healthcare and orthopedic
industries.”
Antony Koblish, President and CEO of Orthovita, said, “We look forward to more detailed
discussions during our earnings conference call scheduled for Tuesday, August 7,
at 8:30 a.m. Eastern Time.
This press release shall not constitute an offer to sell or the solicitation of
an offer to buy, nor shall there be any sale of these securities in any state or
jurisdiction in which such offer, solicitation or sale would be unlawful prior to
registration or qualification under the securities laws of any such state or jurisdiction.
The offer and sale of the 10% senior secured notes due 2012, the warrants issuable
to the purchaser of the 10% senior secured notes due 2012 and the shares of common
stock underlying the warrants, and the shares of common stock issuable as partial
payment for the repurchase of the revenue interest obligation have not been registered
under the United States Securities Act of 1933 or under any state securities laws
and may not be offered or sold in the United States absent registration or an applicable
exemption from the registration requirements of the Securities Act of 1933, as amended.
Conference Call
Antony Koblish, President and Chief Executive Officer, and Albert J. Pavucek, Jr.,
Chief Financial Officer of Orthovita, will host a conference call on Tuesday, August
7, 2007, at 8:30 a.m. Eastern Time, to review and discuss the Company’s financial
results for the second quarter 2007. The phone number to join the conference call
from within the U.S. is (888) 815-2919, and from outside the U.S. is (706) 643-3675.
The conference identification number is 7153873. Participants should dial
in ten minutes prior to the scheduled start time for the conference call.
A replay of the conference call will be available for one week beginning August
7, 2007, at 11:30 a.m. Eastern Time, and ending August 14, 2007, at 11:59 p.m. Eastern
Time. You may listen to the replay by dialing within the U.S. (800) 642-1687
or by dialing from outside the U.S. (706) 645-9291. The replay identification
number is 7153873.
About the Company
Orthovita is a spine and orthopedic biosurgery company with proprietary biomaterials
and biologic technologies for the development and commercialization of synthetic,
biologically active, tissue engineering products. We develop and market synthetic-based
biomaterials products for use in spine surgery, the repair of fractures and a broad
range of clinical needs in the trauma, joint reconstruction, revision and extremities
markets. Our near-term commercial business is based on our VITOSS® Bone Graft
Substitute technology platforms, which are designed to address the non-structural
bone graft market by offering synthetic alternatives to the use of autograft or
cadaver-based bone material, and VITAGEL® Surgical Hemostat, which is an adherent
matrix and an impermeable barrier to blood flow. Our longer-term U.S. clinical development
program is focused on our internally developed CORTOSS® Bone Augmentation Material
technology platform, which is primarily designed for injections in osteoporotic
spines to treat vertebral compression fractures. We work jointly with Kensey Nash
Corporation to develop and commercialize synthetic-based biomaterial products, we
market VITAGEL under a license granted by Angiotech Pharmaceuticals, Inc., and we
continue to pursue similar relationships with other biomaterials companies.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s
current expectations of future events that involve risks and uncertainties, including,
without limitation, the closing of the transactions described herein, the development,
regulatory clearance or approval, demand and market acceptance of our products,
including CORTOSS; the development of our sales network; product acquisitions; the
use of proceeds from equity and debt offerings; and other aspects of our business.
Such statements are based on management’s current expectations and are subject to
a number of substantial risks and uncertainties that could cause actual results
or timeliness to differ materially from those addressed in the forward-looking statements.
Factors that may cause such a difference are listed from time to time in reports
filed by the Company with the U.S. Securities and Exchange Commission (SEC), including
but not limited to risks described in our most recently filed Form 10-K under the
caption "Risk Factors”. Further information about these and other relevant
risks and uncertainties may be found in Orthovita’s filings with the SEC, all of
which are available from the SEC as well as other sources. Orthovita undertakes
no obligation to publicly update any forward-looking statements.
Source: Orthovita, Inc.
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7/27/2007
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Orthovita Schedules Second Quarter 2007 Financial Results Conference Call
MALVERN, Pennsylvania, USA, Friday, July 27, 2007 – Orthovita, Inc. (NASDAQ: VITA),
a spine and orthopedic biosurgery company, will hold a conference call on Tuesday,
August 7, 2007, at 8:30 a.m. Eastern Time, to review and discuss its financial results
for the second quarter 2007. Antony Koblish, President and Chief Executive
Officer, and Albert J. Pavucek, Jr., Chief Financial Officer of Orthovita, will
host the call.
The phone number to join the conference call from within the U.S. is (888) 815-2919,
and from outside the U.S. is (706) 643-3675. The conference identification
number is 7153873. Participants should dial in ten minutes prior to the scheduled
start time for the conference call.
A replay of the conference call will be available for one week beginning August
7, 2007, at 11:30 a.m. Eastern Time, and ending August 14, 2007, at 11:59 p.m. Eastern
Time. You may listen to the replay by dialing within the U.S. (800) 642-1687
or by dialing from outside the U.S. (706) 645-9291. The replay identification
number is 7153873.
About the Company
Orthovita is a spine and orthopedic biosurgery company with proprietary biomaterials
and biologic technologies for the development and commercialization of synthetic,
biologically active, tissue engineering products. We develop and market synthetic-based
biomaterials products for use in spine surgery, the repair of fractures and a broad
range of clinical needs in the trauma, joint reconstruction, revision and extremities
markets. Our near-term commercial business is based on our VITOSS® Bone Graft
Substitute technology platforms, which are designed to address the non-structural
bone graft market by offering synthetic alternatives to the use of autograft or
cadaver-based bone material, and VITAGEL® Surgical Hemostat, which is an adherent
matrix and an impermeable barrier to blood flow. Our longer-term U.S. clinical development
program is focused on our internally developed CORTOSS® Bone Augmentation Material
technology platform, which is primarily designed for injections in osteoporotic
spines to treat vertebral compression fractures. We work jointly with Kensey Nash
Corporation to develop and commercialize synthetic-based biomaterial products, we
market VITAGEL under a license granted by Angiotech Pharmaceuticals, Inc., and we
continue to pursue similar relationships with other companies in biomaterials.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s
current expectations of future events that involve risks and uncertainties, including,
without limitation, the development, regulatory approval, demand and market acceptance
of our products; the development of our sales network; the adequacy of inventory;
our ability to manufacture products; timing of any submissions to the FDA related
to CORTOSS approval; the adequacy of available resources; and other aspects of our
business. Such statements are based on management’s current expectations and
are subject to a number of substantial risks and uncertainties that could cause
actual results or timeliness to differ materially from those addressed in the forward-looking
statements. Factors that may cause such a difference are listed from time
to time in reports filed by the Company with the U.S. Securities and Exchange Commission
(SEC), including but not limited to risks described in our most recently filed Form
10-K under the caption "Risks Factors”. Further information about these
and other relevant risks and uncertainties may be found in Orthovita’s filings with
the SEC, all of which are available from the SEC as well as other sources. Orthovita
undertakes no obligation to publicly update any forward-looking statements.
Source: Orthovita, Inc.
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6/25/2007
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Orthovita to Present at the Jefferies Healthcare Conference
MALVERN, Pennsylvania, Monday, June 25, 2007 – Orthovita, Inc. (NASDAQ: VITA), a
spine and orthopedic biosurgery company, announced today that it will present at
the Jefferies Healthcare Conference in New York. Antony Koblish, president
and chief executive officer of Orthovita, is scheduled to present on Thursday, June
28th, at 1:30 p.m. Eastern Time. An audio-only webcast of this presentation
will be available at http://www.wsw.com/webcast/jeff18/vita
and will be archived at the same URL for 90 days following the conference.
About the Company
Orthovita is a spine and orthopedic biosurgery company with proprietary biomaterials
and biologic technologies for the development and commercialization of synthetic,
biologically active, tissue engineering products. We develop and market synthetic-based
biomaterials products for use in spine surgery, the repair of fractures and a broad
range of clinical needs in the trauma, joint reconstruction, revision and extremities
markets. Our near-term commercial business is based on our VITOSS® Bone Graft
Substitute technology platforms, which are designed to address the non-structural
bone graft market by offering synthetic alternatives to the use of autograft or
cadaver-based bone material, and VITAGEL® Surgical Hemostat, which is an adherent
matrix and an impermeable barrier to blood flow. Our longer-term U.S. clinical
development program is focused on our internally developed CORTOSS® Bone Augmentation
Material technology platform, which is primarily designed for injections in osteoporotic
spines to treat vertebral compression fractures. We work jointly with Kensey
Nash Corporation to develop and commercialize novel synthetic-based biomaterial
products, we market VITAGEL under a license granted by Angiotech Pharmaceuticals,
Inc., and we continue to pursue similar relationships with other companies in biomaterials.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s
current expectations of future events that involve risks and uncertainties, including,
without limitation, the development, regulatory approval, demand and market acceptance
of our products; the development of our sales network; the adequacy of inventory;
our ability to manufacture products; timing of any submissions to the FDA related
to CORTOSS approval; the adequacy of available resources; and other aspects of our
business. Such statements are based on management’s current expectations and
are subject to a number of substantial risks and uncertainties that could cause
actual results or timeliness to differ materially from those addressed in the forward-looking
statements. Factors that may cause such a difference are listed from time
to time in reports filed by the Company with the U.S. Securities and Exchange Commission
(SEC), including but not limited to risks described in our most recently filed Form
10-K under the caption "Risks Factors”. Further information about these
and other relevant risks and uncertainties may be found in Orthovita’s filings with
the SEC, all of which are available from the SEC as well as other sources. Orthovita
undertakes no obligation to publicly update any forward-looking statements.
Source: Orthovita, Inc.
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6/12/2007
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Orthovita in Conjunction with Canaccord Adams will Conduct an Institutional Investors
Meeting on Thursday, June 14th, in Chicago
MALVERN, Pennsylvania, June 12, 2007 – Orthovita, Inc. (NASDAQ: VITA), a spine and
orthopedic biosurgery company, announced today that it will conduct an institutional
investor meeting in conjunction with Canaccord Adams, Inc. on Thursday, June 14th,
2007 in Chicago, IL. Antony Koblish, president and chief executive officer
of Orthovita, Albert J. Pavucek, Jr., Chief Financial Officer, and several members
of Orthovita’s management team will present at the meeting scheduled from 1:00 p.m.
to 5:00 p.m. Central Time, in the Washington Room of The Sears Tower, 233 South
Wacker Drive, Chicago, IL. William J. Plovanic, CFA, managing director, equity
research from Canaccord Adams will be co-hosting the meeting.
In addition, the meeting will feature guest speaker H. Paul Hatten, Jr., M.D., from
Indian River Radiology of Vero Beach, Florida, who will give a presentation entitled
“Treatment of Osteoporotic VCF with CORTOSS®: Preliminary Results and Biomechanical
Considerations from the First Prospective Trial at a Single Institution”, at approximately
2:00 p.m. and will cover part of a prospective randomized controlled study being
conducted under an FDA Investigational Device Exemption (IDE). The study assesses
the safety and efficacy of Orthovita’s CORTOSS compared to commercially available
PMMA bone cements in osteoporotic compression fractures of the vertebra(e).
A total of 256 patients have been enrolled at 19 sites using a 2:1 randomization
with 162 patients assigned to CORTOSS and 94 patients assigned to PMMA. Dr.
Hatten is one of the 19 clinical sites involved in the FDA Investigational Device
Exemption (IDE) study and will cover part of a prospective randomized controlled
study being conducted under an FDA IDE study. At the Indian River Radiology
site, 57 patients have been enrolled; 36 treated using CORTOSS and 21 treated using
PMMA bone cement.
About the Company
Orthovita is a spine and orthopedic biosurgery company with proprietary biomaterials
and biologic technologies for the development and commercialization of synthetic,
biologically active, tissue engineering products. We develop and market synthetic-based
biomaterials products for use in spine surgery, the repair of fractures and a broad
range of clinical needs in the trauma, joint reconstruction, revision and extremities
markets. Our near-term commercial business is based on our VITOSS® Bone Graft
Substitute technology platforms, which are designed to address the non-structural
bone graft market by offering synthetic alternatives to the use of autograft or
cadaver-based bone material, and VITAGEL® Surgical Hemostat, which is an adherent
matrix and an impermeable barrier to blood flow. Our longer-term U.S. clinical development
program is focused on our internally developed CORTOSS® Bone Augmentation Material
technology platform, which is primarily designed for injections in osteoporotic
spines to treat vertebral compression fractures. We work jointly with Kensey Nash
Corporation to develop and commercialize novel synthetic-based biomaterial products,
we market VITAGEL under a license granted by Angiotech Pharmaceuticals, Inc., and
we continue to pursue similar relationships with other companies in biomaterials.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s
current expectations of future events that involve risks and uncertainties, including,
without limitation, the development, regulatory approval, demand and market acceptance
of our products; the development of our sales network; the adequacy of inventory;
our ability to manufacture products; timing of any submissions to the FDA related
to CORTOSS approval; the adequacy of available resources; and other aspects of our
business. Such statements are based on management’s current expectations and
are subject to a number of substantial risks and uncertainties that could cause
actual results or timeliness to differ materially from those addressed in the forward-looking
statements. Factors that may cause such a difference are listed from time
to time in reports filed by the Company with the U.S. Securities and Exchange Commission
(SEC), including but not limited to risks described in our most recently filed Form
10-K under the caption "Risks Factors”. Further information about these
and other relevant risks and uncertainties may be found in Orthovita’s filings with
the SEC, all of which are available from the SEC as well as other sources. Orthovita
undertakes no obligation to publicly update any forward-looking statements.
Source: Orthovita, Inc.
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6/11/2007
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Orthovita Announces Podium Presentation of CORTOSS® for the Treatment of Vertebral
Compression Fractures – Vertebral Augmentation to be Presented at the American Society
of Neuroradiology (ASNR) Meeting in Chicago
MALVERN, Pennsylvania, USA, June 11, 2007 – Orthovita, Inc. (NASDAQ: VITA), a spine
and biosurgery company, reported that H. Paul Hatten, Jr., M.D., from Vero Beach,
Florida, will give a presentation entitled “Treatment of Osteoporotic VCF with CORTOSS®:
Preliminary Results and Biomechanical Considerations from the First Prospective
Trial at a Single Institution”, at the American Society of Neuroradiology (ASNR)
meeting being held in Chicago, IL on Thursday June 14, 2007.
The podium presentation is on Thursday June 14, at 11:43 a.m. in Room Columbus I-L
of the Hyatt Regency and will cover part of a prospective randomized controlled
study being conducted under an FDA Investigational Device Exemption (IDE). The study
assesses the safety and efficacy of CORTOSS compared to commercially available PMMA
bone cements in osteoporotic compression fractures of the vertebra(e). A total of
256 patients have been enrolled at 19 sites using a 2:1 randomization with 162 patients
assigned to CORTOSS and 94 patients assigned to PMMA. Patients are evaluated
at pre-op, post-op, 72 hours, 1 week, 1, 3, 6, 12, and 24 months. Patient
outcomes are assessed over time with the use of the Visual Analogue pain Scale (VAS),
the Oswestry Disability Index (ODI), and the SF-12. Furthermore, maintenance of
height and alignment of the level(s) treated are also monitored over time.
Among the inclusion criteria are a minimum VAS pain score of 50/100, a minimum ODI
score of 30% caused by recent (an) osteoporotic compression fracture(s) at one or
two levels as evidenced by the presence of edema on MRI or bone scan. Exclusion
criteria include greater than 70% vertebral collapse, spinal canal compromise, neurologic
deficit at the level (s) to be treated, or tumors. Post-operative CT and radiographs
are used to assess and quantify leakage. The results reported on this week
were collected by Dr. Hatten at Indian River Radiology of Vero Beach, Florida, one
of the 19 clinical sites involved in this IDE study.
At the Indian River Radiology site, 57 patients have been enrolled; 36 treated using
CORTOSS and 21 treated using PMMA bone cement. The most striking difference
between CORTOSS and PMMA seen in this subset of the larger IDE study is that the
average volume of material injected per vertebra was 1.17 cc for CORTOSS and 2.41
cc for PMMA treated group.
“These preliminary results suggest that CORTOSS may provide similar pain relief
compared to PMMA bone cement with approximately 50% less material,” said Dr. Hatten.
“This may be due to the distinct interdigitated trabecular fill pattern obtained
with CORTOSS, as opposed to the more homogenous “ball-like” fill seen with PMMA.
This difference in fill pattern has the potential to reduce the risk of leakage.
Early laboratory investigations also indicate that this fill pattern in combination
with CORTOSS’ strength may result in a more favorable biomechanical environment.”
There are an estimated 700,000 osteoporotic vertebral compression fractures in the
United States each year. Orthovita believes that the CORTOSS clinical study
is the most rigorous trial ever enrolled for vertebral compression fractures of
the spine. The prospective, randomized study protocol was developed in accordance
with the FDA’s vertebral compression fracture guidance document.
CORTOSS has CE Certification for use in the European Union for screw augmentation
and for vertebral augmentation. This enables CORTOSS to be sold in the European
Union as well as in other countries that have adopted the European Union’s regulatory
standards. CORTOSS is not available for sale in the United States and is limited
to investigational use.
About the Company
Orthovita is a spine and orthopedic biosurgery company with proprietary biomaterials
and biologic technologies for the development and commercialization of synthetic,
biologically active, tissue engineering products. We develop and market synthetic-based
biomaterials products for use in spine surgery, the repair of fractures and a broad
range of clinical needs in the trauma, joint reconstruction, revision and extremities
markets. Our near-term commercial business is based on our VITOSS® Bone Graft
Substitute technology platforms, which are designed to address the non-structural
bone graft market by offering synthetic alternatives to the use of autograft or
cadaver-based bone material, and VITAGEL® Surgical Hemostat, which is an adherent
matrix and an impermeable barrier to blood flow. Our longer-term U.S. clinical development
program is focused on our internally developed CORTOSS® Bone Augmentation Material
technology platform, which is primarily designed for injections in osteoporotic
spines to treat vertebral compression fractures. We work jointly with Kensey Nash
Corporation to develop and commercialize synthetic-based biomaterial products, we
market VITAGEL under a license granted by Angiotech Pharmaceuticals, Inc., and we
continue to pursue similar relationships with other biomaterials companies.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s
current expectations of future events that involve risks and uncertainties, including,
without limitation, the development, regulatory clearance or approval, demand and
market acceptance of our products, including CORTOSS; the timing of any submissions
to the FDA related to CORTOSS clearance or approval; the timing of completion of
enrollment of our CORTOSS U.S. pivotal study; and other aspects of our business.
Such statements are based on management’s current expectations and are subject to
a number of substantial risks and uncertainties that could cause actual results
or timeliness to differ materially from those addressed in the forward-looking statements.
Factors that may cause such a difference are listed from time to time in reports
filed by the Company with the U.S. Securities and Exchange Commission (SEC), including
but not limited to risks described in our most recently filed Form 10-K under the
caption "Risk Factors”. Further information about these and other relevant
risks and uncertainties may be found in Orthovita’s filings with the SEC, all of
which are available from the SEC as well as other sources. Orthovita undertakes
no obligation to publicly update any forward-looking statements.
Source: Orthovita, Inc.
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5/18/2007
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Orthovita Announces Maarten Persenaire, M.D. to Lead Next Phase of CORTOSS® Pivotal
Clinical Trial
MALVERN, Pennsylvania, USA, Friday, May 18, 2007 – Orthovita, Inc. (NASDAQ: VITA),
a spine and biosurgery company, today announced that Dr. Maarten Persenaire, its
Chief Medical Officer, will assume lead responsibility for the CORTOSS clinical
program and research and development. As previously announced, the pivotal CORTOSS
clinical trial was fully enrolled in February 2007. If data from the pivotal
study is supportive, Orthovita intends to seek clearance to market CORTOSS through
a 510(k) submission.
Dr. Persenaire has served as Orthovita’s Chief Medical Officer since April 1999.
Prior to joining Orthovita, Dr. Persenaire served in several positions at AcroMed
Corporation, a DePuy-Johnson & Johnson company, most recently as Vice President
of Clinical Affairs. Dr. Persenaire received his medical degree from the Groningen
State University in The Netherlands in 1982 and served his internship and residency
in internal medicine and surgery at the Greertruiden Hospital, The Netherlands,
until 1983.
"Maarten has over 15 years of experience in spine and orthopedics. He
was extensively involved in the CORTOSS clinical trials that resulted in the approval
of CORTOSS in Europe. In addition, he has been an active participant in all
U.S. clinical trial programs, including the current pivotal clinical trial for CORTOSS.
We look forward to his continued contributions toward obtaining clearance of CORTOSS
in the U.S.," stated Antony Koblish, Chief Executive Officer of Orthovita.
About the Company
Orthovita is a spine and orthopedic biosurgery company with proprietary biomaterials
and biologic technologies for the development and commercialization of synthetic,
biologically active, tissue engineering products. We develop and market synthetic-based
biomaterials products for use in spine surgery, the repair of fractures and a broad
range of clinical needs in the trauma, joint reconstruction, revision and extremities
markets. Our near-term commercial business is based on our VITOSS® Bone Graft
Substitute technology platforms, which are designed to address the non-structural
bone graft market by offering synthetic alternatives to the use of autograft or
cadaver-based bone material, and VITAGEL® Surgical Hemostat, which is an adherent
matrix and an impermeable barrier to blood flow. Our longer-term U.S. clinical development
program is focused on our internally developed CORTOSS® Bone Augmentation Material
technology platform, which is primarily designed for injections in osteoporotic
spines to treat vertebral compression fractures. We work jointly with Kensey Nash
Corporation to develop and commercialize synthetic-based biomaterial products, we
market VITAGEL under a license granted by Angiotech Pharmaceuticals, Inc., and we
continue to pursue similar relationships with other companies in biomaterials.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s
current expectations of future events that involve risks and uncertainties, including,
without limitation, the development, regulatory clearance or approval, demand and
market acceptance of our products, including CORTOSS; the development of our sales
network; and other aspects of our business. Such statements are based on management’s
current expectations and are subject to a number of substantial risks and uncertainties
that could cause actual results or timeliness to differ materially from those addressed
in the forward-looking statements. Factors that may cause such a difference
are listed from time to time in reports filed by the Company with the U.S. Securities
and Exchange Commission (SEC), including but not limited to risks described in our
most recently filed Form 10-K under the caption "Risks Factors”. Further
information about these and other relevant risks and uncertainties may be found
in Orthovita’s filings with the SEC, all of which are available from the SEC as
well as other sources. Orthovita undertakes no obligation to publicly update any
forward-looking statements.
Source: Orthovita, Inc.
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5/7/2007
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Orthovita Reports 2007 First Quarter Financial
Results
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5/2/2007
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Orthovita Schedules First Quarter 2007 Financial Results Conference Call
MALVERN, Pennsylvania, USA, Wednesday, May 2, 2007 – Orthovita, Inc. (NASDAQ: VITA),
a spine and biosurgery company, will hold a conference call on Monday, May 7, 2007,
at 8:30 a.m. Eastern Time, to review and discuss its financial results for the first
quarter 2007. Antony Koblish, President and Chief Executive Officer, and Albert
J. Pavucek, Jr., Chief Financial Officer of Orthovita, will host the call.
The phone number to join the conference call from within the U.S. is (888) 815-2919,
and from outside the U.S. is (706) 643-3675. The conference identification
number is 6099428. Participants should dial in ten minutes prior to the scheduled
start time for the conference call.
A replay of the conference call will be available for one week beginning May 7,
2007, at 11:30 a.m. Eastern Time, and ending May 14, 2007, at 11:59 p.m. Eastern
Time. You may listen to the replay by dialing within the U.S. (800) 642-1687
or by dialing from outside the U.S. (706) 645-9291. The replay identification
number is 6099428.
About the Company
Orthovita is a spine and orthopedic biosurgery company with proprietary biomaterials
and biologic technologies for the development and commercialization of synthetic,
biologically active, tissue engineering products. We develop and market synthetic-based
biomaterials products for use in spine surgery, the repair of fractures and a broad
range of clinical needs in the trauma, joint reconstruction, revision and extremities
markets. Our near-term commercial business is based on our VITOSS® Bone Graft
Substitute technology platforms, which are designed to address the non-structural
bone graft market by offering synthetic alternatives to the use of autograft or
cadaver-based bone material, and VITAGEL® Surgical Hemostat, which is an adherent
matrix and an impermeable barrier to blood flow. Our longer-term U.S. clinical development
program is focused on our internally developed CORTOSS® Bone Augmentation Material
technology platform, which is primarily designed for injections in osteoporotic
spines to treat vertebral compression fractures. We work jointly with Kensey Nash
Corporation to develop and commercialize synthetic-based biomaterial products, we
market VITAGEL under a license granted by Angiotech Pharmaceuticals, Inc., and we
continue to pursue similar relationships with other companies in biomaterials.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s
current expectations of future events that involve risks and uncertainties, including,
without limitation, the development, regulatory clearance or approval, demand and
market acceptance of our products, including CORTOSS; the development of our sales
network; and other aspects of our business. Such statements are based on management’s
current expectations and are subject to a number of substantial risks and uncertainties
that could cause actual results or timeliness to differ materially from those addressed
in the forward-looking statements. Factors that may cause such a difference
are listed from time to time in reports filed by the Company with the U.S. Securities
and Exchange Commission (SEC), including but not limited to risks described in our
most recently filed Form 10-K under the caption "Risks Factors”. Further
information about these and other relevant risks and uncertainties may be found
in Orthovita’s filings with the SEC, all of which are available from the SEC as
well as other sources. Orthovita undertakes no obligation to publicly update any
forward-looking statements.
Source: Orthovita, Inc.
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3/27/2007
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Orthovita, Inc. Appoints New Director
Paul Touhey of Fujirebio Diagnostics, Inc. joins Orthovita’s Board of Directors
MALVERN, Pennsylvania, USA, March 27, 2007 – Orthovita, Inc. (NASDAQ: VITA), a spine
and orthopedic biosurgery company, announced the appointment of Paul Touhey to its
Board of Directors (the “Board”) today.
Mr. Touhey has over twenty-five years of experience in the healthcare, medical device,
diagnostics and biopharmaceutical industries. He is President, Chief Operating Officer
and a member of the Board of Directors of Fujirebio Diagnostics, Inc., which is
a subsidiary of Miraca Holdings, Inc., a healthcare holding company based in Tokyo,
Japan principally engaged in laboratory testing services and in vitro diagnostic
products. Prior to his appointment as President and Chief Operating Officer
in 2003, Mr. Touhey served as Fujirebio Diagnostics’ Senior Vice President (1999-2003)
and Vice President of Operations (1998-1999). Prior to joining Fujirebio Diagnostics,
he served in various executive positions at Centocor, Inc., including Vice President
of Centocor’s Diagnostics Division. Centocor, Inc. is a subsidiary of Johnson
& Johnson.
Mr. Touhey is also a member of the Board of Directors of the Medical Device Manufacturers
Association (MDMA), a position he has held since 1996. From 2000 to 2003,
Mr. Touhey served as Chairman of the Board of MDMA.
Antony Koblish, Orthovita’s Chief Executive Officer, stated, “Paul’s critical skills
and experience will make him a great resource for our company. He has a proven
management track record, significant manufacturing experience and extensive knowledge
of the FDA regulatory process for medical devices. We are very pleased to
have him join our Board.”
About the Company
Orthovita is a spine and orthopedic biosurgery company with proprietary biomaterials
and biologic technologies for the development and commercialization of synthetic,
biologically active, tissue engineering products. We develop and market synthetic-based
biomaterials products for use in spine surgery, the repair of fractures and a broad
range of clinical needs in the trauma, joint reconstruction, revision and extremities
markets. Our near-term commercial business is based on our VITOSS® Bone Graft
Substitute technology platforms, which are designed to address the non-structural
bone graft market by offering synthetic alternatives to the use of autograft or
cadaver-based bone material, and VITAGEL® Surgical Hemostat, which is an adherent
matrix and an impermeable barrier to blood flow. Our longer-term U.S. clinical development
program is focused on our internally developed CORTOSS® Bone Augmentation Material
technology platform, which is primarily designed for injections in osteoporotic
spines to treat vertebral compression fractures. We work jointly with Kensey Nash
Corporation to develop and commercialize synthetic-based biomaterial products, we
market VITAGEL under a license granted by Angiotech Pharmaceuticals, Inc., and we
continue to pursue similar relationships with other biomaterials companies.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s
current expectations of future events that involve risks and uncertainties, including,
without limitation, the development, regulatory clearance or approval, demand and
market acceptance of our products, including CORTOSS; the development of our sales
network; and other aspects of our business. Such statements are based on management’s
current expectations and are subject to a number of substantial risks and uncertainties
that could cause actual results or timeliness to differ materially from those addressed
in the forward-looking statements. Factors that may cause such a difference
are listed from time to time in reports filed by Orthovita with the U.S. Securities
and Exchange Commission (SEC), including but not limited to risks described in our
most recently filed Form 10-K under the caption "Risk Factors.” Further
information about these and other relevant risks and uncertainties may be found
in Orthovita’s filings with the SEC, all of which are available from the SEC as
well as other sources. Orthovita undertakes no obligation to publicly update any
forward-looking statements.
Source: Orthovita, Inc.
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3/12/2007
|
Orthovita Reports 2006 Fourth Quarter and Year-End
Financial Results
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3/5/2007
|
Orthovita Schedules Fourth Quarter and Year-End 2006 Financial Results Conference
Call
MALVERN, Pennsylvania, USA, Monday, March 5, 2007 – Orthovita, Inc. (NASDAQ: VITA),
a spine and biosurgery company, will hold a conference call on Monday, March 12,
2007, at 8:30 a.m. Eastern Time, to review and discuss its financial results for
the fourth quarter and year-end 2006. Antony Koblish, President and Chief
Executive Officer, Albert J. Pavucek, Jr., Chief Financial Officer, and Joseph M.
Paiva, Chief Business Officer of Orthovita, will host the call.
The phone number to join the conference call from within the U.S. is (888) 815-2919,
and from outside the U.S. is (706) 643-3675. The conference identification
number is 1380686. Participants should dial in ten minutes prior to the scheduled
start time for the conference call.
A replay of the conference call will be available for one week beginning March 12,
2007, at 11:30 a.m. Eastern Time, and ending March 19, 2007, at 11:59 p.m. Eastern
Time. You may listen to the replay by dialing within the U.S. (800) 642-1687
or by dialing from outside the U.S. (706) 645-9291. The replay identification
number is 1380686.
About the Company
Orthovita is a spine and orthopedic biosurgery company with proprietary biomaterials
and biologic technologies for the development and commercialization of synthetic,
biologically active, tissue engineering products. We develop and market synthetic-based
biomaterials products for use in spine surgery, the repair of fractures and a broad
range of clinical needs in the trauma, joint reconstruction, revision and extremities
markets. Our near-term commercial business is based on our VITOSS® Bone Graft
Substitute technology platforms, which are designed to address the non-structural
bone graft market by offering synthetic alternatives to the use of autograft or
cadaver-based bone material, and VITAGEL® Surgical Hemostat, which is an adherent
matrix and an impermeable barrier to blood flow. Our longer-term U.S. clinical development
program is focused on our internally developed CORTOSS® Bone Augmentation Material
technology platform, which is primarily designed for injections in osteoporotic
spines to treat vertebral compression fractures. We work jointly with Kensey Nash
Corporation to develop and commercialize novel synthetic-based biomaterial products,
we market VITAGEL under a license granted by Angiotech Pharmaceuticals, Inc., and
we continue to pursue similar relationships with other companies in biomaterials.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s
current expectations of future events that involve risks and uncertainties, including,
without limitation, the development, regulatory approval, demand and market acceptance
of our products; the development of our sales network; the adequacy of inventory;
our ability to manufacture products; timing of any submissions to the FDA related
to CORTOSS approval; the adequacy of available resources; and other aspects of our
business. Such statements are based on management’s current expectations and
are subject to a number of substantial risks and uncertainties that could cause
actual results or timeliness to differ materially from those addressed in the forward-looking
statements. Factors that may cause such a difference are listed from time
to time in reports filed by the Company with the U.S. Securities and Exchange Commission
(SEC), including but not limited to risks described in our most recently filed Form
10-K under the caption "Risks Factors”. Further information about these
and other relevant risks and uncertainties may be found in Orthovita’s filings with
the SEC, all of which are available from the SEC as well as other sources. Orthovita
undertakes no obligation to publicly update any forward-looking statements.
Source: Orthovita, Inc.
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3/2/2007
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CORTOSS® Podium Presentation Scheduled For The 32nd Annual Scientific Meeting Of
The Society Of Interventional Radiology
Treatment of Vertebral Compression Fractures with CORTOSS-Preliminary Results at
a Single Institution in a Prospective Randomized Clinical Trial
MALVERN, Pennsylvania, USA, Friday, March 2, 2007 – Orthovita, Inc. (NASDAQ: VITA),
a spine and biosurgery company, reported that H. Paul Hatten, Jr., M.D., from Indian
River Radiology, Vero Beach, Florida, will make a podium presentation of a scientific
paper titled “Treatment of Vertebral Compression Fractures with CORTOSS - Preliminary
Results at a Single Institution in a Prospective Randomized Clinical Trial” at the
32nd Annual Scientific Meeting of the Society of Interventional Radiology being
held in Seattle from March 1 through March 6, 2007.
The podium presentation is on Monday, March 5, 2007 at 2:45 p.m. Pacific Time in
the Non-Vascular Interventions: Biopsy/Spine session. The presentation will
cover part of a pivotal study being conducted under an FDA Investigational Device
Exemption (IDE) to assess the safety and efficacy of CORTOSS compared to commercially
available PMMA bone cements. A total of 256 patients have been enrolled in
the pivotal study with a 2:1 randomization (162 patients treated using CORTOSS and
94 patients treated using a PMMA bone cement) at 22 clinical sites. Patients
are evaluated at pre-op, post-op, 72 hours, 1 week, 1, 3, 6, 12, and 24 months.
Patient outcome will be assessed by Visual Analog Scale (VAS), Oswestry Disability
Index (ODI), SF-12 and maintenance of height and alignment at the level(s) treated.
Among the inclusion criteria are a minimum VAS score of 50, a minimum ODI score
of 30%, an osteoporotic compression fracture at one or two levels, presence of edema
on MRI or bone scan and an informed patient consent. Exclusionary criteria include
greater than 70% collapse, spinal canal compromise, neurologic deficit at the level(s)
to be treated, or tumors. Post-operative CT and radiographs are being used
to assess and quantify leakage. The results reported in the podium presentation
are from the Indian River Radiology site in Vero Beach, Florida, which is one of
the clinical sites involved in the pivotal study.
At the Indian River Radiology site, 57 patients have been enrolled; 36 treated using
CORTOSS and 21 treated using a PMMA bone cement. A total of 78 vertebral levels
have been treated; 50 in the CORTOSS treated group and 28 in the PMMA treated group.
The average age is 77 in the CORTOSS treated group and 78 in the PMMA treated group.
Improvement in VAS and ODI scores was similar for both groups out to 12 months.
The average volume of material injected in the CORTOSS treated group was 1.9 cc
and 3.5 cc in the PMMA treated group. Leakages were observed on post-operative CT
scans and found to be similar in both groups. All extravasations were asymptomatic
with no cardio-pulmonary complications.
“These preliminary results suggest that CORTOSS may provide similar pain relief
compared to PMMA bone cement with approximately 50% less material,” said Dr. Hatten.
“This may be due to the distinct interdigitated fill pattern obtained with CORTOSS,
which may reduce the risk of leakage and emboli while employing a “start-stop” technique
and precision delivery.”
CORTOSS has CE Certification for use in the European Union for screw augmentation
and for vertebral augmentation of VCFs of the spine, which enables it to be sold
in the European Union as well as in other countries that have adopted the European
Union’s regulatory standards. A prospective, randomized, controlled multi-center
IDE study is underway in the U.S. designed to demonstrate that CORTOSS is safe and
effective for the treatment of osteoporotic vertebral compression fractures.
CORTOSS is not available for sale in the United States and is limited to investigational
use.
About the Company
Orthovita is a spine and orthopedic biosurgery company with proprietary biomaterials
and biologic technologies for the development and commercialization of synthetic,
biologically active, tissue engineering products. We develop and market synthetic-based
biomaterials products for use in spine surgery, the repair of fractures and a broad
range of clinical needs in the trauma, joint reconstruction, revision and extremities
markets. Our near-term commercial business is based on our VITOSS® Bone Graft
Substitute technology platforms, which are designed to address the non-structural
bone graft market by offering synthetic alternatives to the use of autograft or
cadaver-based bone material, and VITAGEL® Surgical Hemostat, which is an adherent
matrix and an impermeable barrier to blood flow. Our longer-term U.S. clinical development
program is focused on our internally developed CORTOSS® Bone Augmentation Material
technology platform, which is primarily designed for injections in osteoporotic
spines to treat vertebral compression fractures. We work jointly with Kensey Nash
Corporation to develop and commercialize novel synthetic-based biomaterial products,
we market VITAGEL under a license granted by Angiotech Pharmaceuticals, Inc., and
we continue to pursue similar relationships with other companies in biomaterials.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s
current expectations of future events that involve risks and uncertainties, including,
without limitation, the development, regulatory approval, demand and market acceptance
of our products; the development of our sales network; the adequacy of inventory;
our ability to manufacture products; timing of any submissions to the FDA related
to CORTOSS approval; the adequacy of available resources; and other aspects of our
business. Such statements are based on management’s current expectations and
are subject to a number of substantial risks and uncertainties that could cause
actual results or timeliness to differ materially from those addressed in the forward-looking
statements. Factors that may cause such a difference are listed from time
to time in reports filed by the Company with the U.S. Securities and Exchange Commission
(SEC), including but not limited to risks described in our most recently filed Form
10-K under the caption "Risks Factors”. Further information about these
and other relevant risks and uncertainties may be found in Orthovita’s filings with
the SEC, all of which are available from the SEC as well as other sources. Orthovita
undertakes no obligation to publicly update any forward-looking statements.
Source: Orthovita, Inc.
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2/27/2007
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Orthovita to Present at Susquehanna Financial Group’s SIGnificant Investment Options
in Healthcare Conference
MALVERN, Pennsylvania, Tuesday, February 27, 2007 – Orthovita, Inc. (NASDAQ: VITA),
a spine and orthopedic biosurgery company, announced today that it will present
at Susquehanna Financial Group’s SIGnificant Investment Options in Healthcare
Conference. Antony Koblish, presid icer of Orthovita,
is scheduled to present on Thursday, March 1st, at 9:00 a.m. Eastern Time, at The
Omni Berkshire Place Hotel, 21 East 52nd Street at Madison Avenue, New York, NY.
A webcast of this presentation will be available at
http://www.wsw.com/webcast/sig4/vita and will be archived at the same URL
for 90 days following the conference.
About the Company
Orthovita is a spine and orthopedic biosurgery company with proprietary biomaterials
and biologic technologies for the development and commercialization of synthetic,
biologically active, tissue engineering products. We develop and market synthetic-based
biomaterials products for use in spine surgery, the repair of fractures and a broad
range of clinical needs in the trauma, joint reconstruction, revision and extremities
markets. Our near-term commercial business is based on our VITOSS® Bone Graft
Substitute technology platforms, which are designed to address the non-structural
bone graft market by offering synthetic alternatives to the use of autograft or
cadaver-based bone material, and VITAGEL® Surgical Hemostat, which is an adherent
matrix and an impermeable barrier to blood flow. Our longer-term U.S. clinical development
program is focused on our internally developed CORTOSS® Bone Augmentation Material
technology platform, which is primarily designed for injections in osteoporotic
spines to treat vertebral compression fractures. We work jointly with Kensey Nash
Corporation to develop and commercialize novel synthetic-based biomaterial products,
we market VITAGEL under a license granted by Angiotech Pharmaceuticals, Inc., and
we continue to pursue similar relationships with other companies in biomaterials.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s
current expectations of future events that involve risks and uncertainties, including,
without limitation, the development, regulatory approval, demand and market acceptance
of our products; the development of our sales network; the adequacy of inventory;
our ability to manufacture products; timing of any submissions to the FDA related
to CORTOSS approval; the adequacy of available resources; and other aspects of our
business. Such statements are based on management’s current expectations and
are subject to a number of substantial risks and uncertainties that could cause
actual results or timeliness to differ materially from those addressed in the forward-looking
statements. Factors that may cause such a difference are listed from time
to time in reports filed by the Company with the U.S. Securities and Exchange Commission
(SEC), including but not limited to risks described in our most recently filed Form
10-K under the caption "Risks Factors”. Further information about these
and other relevant risks and uncertainties may be found in Orthovita’s filings with
the SEC, all of which are available from the SEC as well as other sources. Orthovita
undertakes no obligation to publicly update any forward-looking statements.
Source: Orthovita, Inc.
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2/21/2007
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Orthovita Announces Completion of Patient Enrollment in Its U.S. Pivotal Clinical
Study for the Use of CORTOSS® in the Treatment of Vertebral Compression Fractures
The prospective randomized FDA IDE study assesses the safety and efficacy of CORTOSS
Bone Augmentation Material for the treatment of osteoporotic vertebral compression
fractures as compared to commercially available polymethylmethacrylate (PMMA) bone
cement.
MALVERN, Pennsylvania, USA, Wednesday, February 21, 2007 – Orthovita, Inc. (NASDAQ:
VITA), a spine and orthopedic biosurgery company, reported that it has completed
patient enrollment for its pivotal, prospective, randomized study for CORTOSS® Bone
Augmentation Material in development for the treatment of vertebral compression
fractures. The study is being conducted under an FDA Investigational Device
Exemption (IDE) and is designed to assess the safety and efficacy of CORTOSS for
the treatment of osteoporotic vertebral compression fractures as compared to commercially
available polymethylmethacrylate (PMMA) bone cement. A total of 256 patients
are enrolled in the pivotal study with a randomization of approximately 2:1 (162
patients treated using CORTOSS and 94 patients treated using a PMMA bone cement)
at 22 sites.
In the study, patient outcomes are being assessed by Visual Analog Scale (VAS),
Oswestry Disability Index (ODI), SF-12 and maintenance of height and alignment at
the level(s) treated. The study was open to patients with an osteoporotic
compression fracture at one or two levels who also had a minimum VAS score of 50,
a minimum ODI score of 30%, presence of edema on MRI or bone scan and who met certain
other eligibility criteria. Exclusionary criteria include greater than 70% collapse
of vertebrae, spinal canal compromise, neurologic deficit at the level(s) to be
treated, or tumors. Patients are monitored with post-operative CT scans and
radiographs to assess and quantify any material extravasations.
“We appreciate the recruitment efforts of our dedicated clinical investigators and
their diligent study coordinators for the CORTOSS study. We anticipate that
their work in the study will yield sufficient data for analysis and ultimate submission
to the FDA,” said Dr. Erik Erbe, chief science officer of Orthovita.
“The completion of enrollment in this trial is a major milestone for Orthovita and
an important event in the effort to understand and treat vertebral compression fractures
of the spine,” added Antony Koblish, president & chief executive officer of
Orthovita. “Pending regulatory clearance, CORTOSS is positioned to be the first
new, proprietary biomaterial implant for the treatment of vertebral compression
fractures and an alternative to PMMA bone cements available today.”
There are an estimated 700,000 osteoporotic vertebral compression fractures in the
United States each year. Orthovita believes that the CORTOSS clinical study
is the most rigorous trial ever enrolled for vertebral compression fractures of
the spine. The prospective, randomized study protocol was developed in accordance
with the FDA’s vertebral compression fracture guidance document.
CORTOSS has CE Certification for use in the European Union for screw augmentation
and for vertebral augmentation. This enables CORTOSS to be sold in the European
Union as well as in other countries that have adopted the European Union’s regulatory
standards. CORTOSS is not available for sale in the United States and is limited
to investigational use.
About the Company
Orthovita is a spine and orthopedic biosurgery company with proprietary biomaterials
and biologic technologies for the development and commercialization of synthetic,
biologically active, tissue engineering products. We develop and market synthetic-based
biomaterials products for use in spine surgery, the repair of fractures and a broad
range of clinical needs in the trauma, joint reconstruction, revision and extremities
markets. Our near-term commercial business is based on our VITOSS® Bone Graft
Substitute technology platform, which is designed to address the non-structural
bone graft market by offering synthetic alternatives to the use of autograft or
cadaver-based bone material, and VITAGEL® Surgical Hemostat, which is an adherent
matrix and an impermeable barrier to blood flow. Our longer-term U.S. clinical development
program is focused on our internally developed CORTOSS® Bone Augmentation Material,
which is primarily designed for injections in osteoporotic spines to treat vertebral
compression fractures. We work jointly with Kensey Nash Corporation to develop and
commercialize synthetic-based biomaterial products, we market VITAGEL under a license
granted by Angiotech Pharmaceuticals (US), Inc., and we continue to pursue similar
relationships with other biomaterials companies.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s
current expectations of future events that involve risks and uncertainties, including,
without limitation, the development, regulatory clearance, demand and market acceptance
of our products, including CORTOSS; the timing of any submissions to the FDA related
to CORTOSS clearance; data results from our CORTOSS pivotal study; and other aspects
of our business. Such statements are based on management’s current expectations
and are subject to a number of substantial risks and uncertainties that could cause
actual results or timeliness to differ materially from those addressed in the forward-looking
statements. Factors that may cause such a difference are listed from time
to time in reports filed by the Company with the U.S. Securities and Exchange Commission
(SEC), including but not limited to risks described in our most recently filed Form
10-K under the caption "Risk Factors”. Further information about these
and other relevant risks and uncertainties may be found in Orthovita’s filings with
the SEC, all of which are available from the SEC as well as other sources. Orthovita
undertakes no obligation to publicly update any forward-looking statements.
Source: Orthovita, Inc.
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2/20/2007
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CORTOSS® Podium Presentation Scheduled For American Society of Spine Radiologists
Meeting
MALVERN, Pennsylvania, USA, Tuesday, February 20, 2007 – Orthovita, Inc. (NASDAQ:
VITA), a spine and biosurgery company, reported that H. Paul Hatten, Jr., M.D.,
from Indian River Radiology, Vero Beach, Florida, will make a podium presentation
of a scientific paper titled “Prospective Randomized Trial Of CORTOSS Versus PMMA
In The Treatment Of Vertebral Compression Fractures; Preliminary Results At A Single
Institution” at the American Society of Spine Radiologists Meeting (ASSR) meeting
being held in Marco Island, Florida from February 22 through February 25, 2007.
The podium presentation is on Thursday, February 22, at 2:00 p.m. at the Marco Island
Marriott Beach Resort and will cover part of a pivotal study being conducted under
an FDA Investigational Device Exemption (IDE) to assess the safety and efficacy
of CORTOSS compared to commercially available PMMA bone cements. A total of
256 patients are to be enrolled in the pivotal study with a 2:1 randomization (162
patients treated using CORTOSS and 94 patients treated using a PMMA bone cement)
at 22 clinical sites. Patients are evaluated at pre-op, post-op, 72 hours,
1 week, 1, 3, 6, 12, and 24 months. Patient outcome will be assessed by Visual
Analog Scale (VAS), Oswestry Disability Index (ODI), SF-12 and maintenance of height
and alignment at the level(s) treated. Among the inclusion criteria are a
minimum VAS score of 50, a minimum ODI score of 30%, an osteoporotic compression
fracture at one or two levels, presence of edema on MRI or bone scan and an informed
patient consent. Exclusionary criteria include greater than 70% collapse, spinal
canal compromise, neurologic deficit at the level(s) to be treated, or tumors.
Post-operative CT and radiographs are being used to assess and quantify leakage.
The results reported in the podium presentation are from the Indian River Radiology
site in Vero Beach, Florida, which is one of the clinical sites involved in the
pivotal study.
At the Indian River Radiology site, 57 patients have been enrolled; 36 treated using
CORTOSS and 21 treated using a PMMA bone cement. A total of 78 vertebral levels
have been treated; 50 in the CORTOSS treated group and 28 in the PMMA treated group.
The average age is 77 in the CORTOSS treated group and 78 in the PMMA treated group.
Improvement in VAS and ODI scores was similar for both groups out to 12 months.
The average volume of material injected in the CORTOSS treated group was 1.9 cc
and 3.5 cc in the PMMA treated group. Leakages were observed on post-operative CT
scans and found to be similar in both groups. All extravasations were asymptomatic
with no cardio-pulmonary complications.
“These preliminary results suggest that CORTOSS may provide similar pain relief
compared to PMMA bone cement with approximately 50% less material,” said Dr. Hatten.
“This may be due to the distinct interdigitated fill pattern obtained with CORTOSS,
which may reduce the risk of leakage and emboli while employing a “start-stop” technique
and precision delivery.”
CORTOSS has CE Certification for use in the European Union for screw augmentation
and for vertebral augmentation of VCFs of the spine, which enables it to be sold
in the European Union as well as in other countries that have adopted the European
Union’s regulatory standards. A prospective, randomized, controlled multi-center
IDE study is underway in the U.S. designed to demonstrate that CORTOSS is safe and
effective for the treatment of osteoporotic vertebral compression fractures.
CORTOSS is not available for sale in the United States and is limited to investigational
use.
About the Company
Orthovita is a spine and orthopedic biosurgery company with proprietary biomaterials
and biologic technologies for the development and commercialization of synthetic,
biologically active, tissue engineering products. We develop and market synthetic-based
biomaterials products for use in spine surgery, the repair of fractures and a broad
range of clinical needs in the trauma, joint reconstruction, revision and extremities
markets. Our near-term commercial business is based on our VITOSS® Bone Graft
Substitute technology platform, which is designed to address the non-structural
bone graft market by offering synthetic alternatives to the use of autograft or
cadaver-based bone material, and VITAGEL® Surgical Hemostat, which is an adherent
matrix and an impermeable barrier to blood flow. Our longer-term U.S. clinical development
program is focused on our internally developed CORTOSS® Bone Augmentation Material,
which is primarily designed for injections in osteoporotic spines to treat vertebral
compression fractures. We work jointly with Kensey Nash Corporation to develop and
commercialize synthetic-based biomaterial products, we market VITAGEL under a license
granted by Angiotech Pharmaceuticals (US), Inc., and we continue to pursue similar
relationships with other biomaterials companies.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s
current expectations of future events that involve risks and uncertainties, including,
without limitation, the development, regulatory clearance or approval, demand and
market acceptance of our products, including CORTOSS; the timing of any submissions
to the FDA related to CORTOSS clearance or approval; the timing of completion of
enrollment of our CORTOSS U.S. pivotal study; and other aspects of our business.
Such statements are based on management’s current expectations and are subject to
a number of substantial risks and uncertainties that could cause actual results
or timeliness to differ materially from those addressed in the forward-looking statements.
Factors that may cause such a difference are listed from time to time in reports
filed by the Company with the U.S. Securities and Exchange Commission (SEC), including
but not limited to risks described in our most recently filed Form 10-K under the
caption "Risk Factors”. Further information about these and other relevant
risks and uncertainties may be found in Orthovita’s filings with the SEC, all of
which are available from the SEC as well as other sources. Orthovita undertakes
no obligation to publicly update any forward-looking statements.
Source: Orthovita, Inc.
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2/7/2007
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Orthovita Announces Appointment of Chief Business Officer and Chief Financial Officer
MALVERN, Pennsylvania, USA, February 7, 2007 – Orthovita, Inc. (NASDAQ: VITA), a
spine and orthopedic biosurgery company, announced that effective February 8, 2007,
Orthovita’s Chief Financial Officer Joseph M. Paiva will be appointed Orthovita’s
Chief Business Officer. Mr. Paiva joined Orthovita in 1997 as Chief Financial
Officer. Albert J. Pavucek, Jr. will concurrently be appointed Orthovita’s Chief
Financial Officer. Mr. Pavucek joined Orthovita in September 2006 as Vice
President, Finance and Controller.
Antony Koblish, Chief Executive Officer of Orthovita, commented, “Joe has an established
record of contributing to the success of Orthovita over the years. In the
newly created position of Chief Business Officer, Joe will be responsible for strategic
planning, business development and investor relations. Joe’s extensive financial
and industry knowledge will be very useful in his new role to help support the growth
of the Company and leverage the investment we have made in our biomaterial–focused
sales and distribution channel.”
Mr. Pavucek has over twenty years of progressive experience in the areas of finance,
business planning and operations. Prior to joining Orthovita, Mr. Pavucek
served as Vice President, Finance and Operations of PDI, Inc., a biopharmaceutical
commercialization partner, starting in 2002. Previously at PDI, Inc., Mr. Pavucek
served as Executive Director, Controller since 2001. From 1994 to 2001, he served
at Astra Zeneca, L.P. in finance and operations roles of increasing responsibility,
culminating as Sales Force Controller in 1996.
“Al’s strong finance background, experience and knowledge of the life sciences industry
are important assets to Orthovita. We look forward to Al’s financial leadership
and contribution to our management team,” said Mr. Koblish.
About the Company
Orthovita is a spine and orthopedic biosurgery company with proprietary biomaterials
and biologic technologies for the development and commercialization of synthetic,
biologically active, tissue engineering products. We develop and market synthetic-based
biomaterials products for use in spine surgery, the repair of fractures and a broad
range of clinical needs in the trauma, joint reconstruction, revision and extremities
markets. Our near-term commercial business is based on our VITOSS® Bone Graft
Substitute technology platform, which are designed to address the non-structural
bone graft market by offering synthetic alternatives to the use of autograft or
cadaver-based bone material, and VITAGEL® Surgical Hemostat, which is an adherent
matrix and an impermeable barrier to blood flow. Our longer-term U.S. clinical development
program is focused on our internally developed CORTOSS® Bone Augmentation Material,
which is primarily designed for injections in osteoporotic spines to treat vertebral
compression fractures. We work jointly with Kensey Nash Corporation to develop and
commercialize synthetic-based biomaterial products, we market VITAGEL under a license
granted by Angiotech Pharmaceuticals (US), Inc., and we continue to pursue similar
relationships with other biomaterials companies.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s
current expectations of future events that involve risks and uncertainties, including,
without limitation, the development, regulatory clearance or approval, demand and
market acceptance of our products, including CORTOSS; the timing of any submissions
to the FDA related to CORTOSS clearance or approval; and other aspects of our business.
Such statements are based on management’s current expectations and are subject to
a number of substantial risks and uncertainties that could cause actual results
or timeliness to differ materially from those addressed in the forward-looking statements.
Factors that may cause such a difference are listed from time to time in reports
filed by the Company with the U.S. Securities and Exchange Commission (SEC), including
but not limited to risks described in our most recently filed Form 10-K under the
caption "Risk Factors”. Further information about these and other relevant
risks and uncertainties may be found in Orthovita’s filings with the SEC, all of
which are available from the SEC as well as other sources. Orthovita undertakes
no obligation to publicly update any forward-looking statements.
Source: Orthovita, Inc.
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2/6/2007
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Orthovita Reports 2006 Fourth Quarter and Full Year Sales
MALVERN, Pennsylvania, USA, February 6, 2007 – Orthovita, Inc. (NASDAQ: VITA), a
spine and orthopedic biosurgery company, reported that product sales for the three
months ended December 31, 2006 increased 38% to approximately $13.8 million, as
compared to $10.0 million for the same period in 2005. Product sales for the twelve
months ended December 31, 2006 increased 35% to approximately $46.8 million as compared
to $34.7 million for the same period in 2005.
Product sales results reported for 2006 are unaudited.
Product sales for the three and twelve months ended December 31, 2006 included $0.7
million and $0.9 million, respectively, of Endoskeleton™ product sales compared
to $0.1 million and $0.5 million, respectively, for the same periods in 2005.
On January 15, 2007, Orthovita entered into an Asset Purchase Agreement, pursuant
to which Orthovita will sell the assets associated with the Endoskeleton product
line for approximately $0.45 million, including intellectual property rights, inventory
and the 510(k) clearance for the Endoskeleton TA vertebral body replacement device.
The closing of the asset sale transaction is expected to occur on or before February
15, 2007 and is subject to the satisfaction of due diligence and other customary
closing conditions. Upon the completion of the asset sale, Orthovita will
no longer manufacture or sell the Endoskeleton products.
About the Company
Orthovita is a spine and orthopedic biosurgery company with proprietary biomaterials
and biologic technologies for the development and commercialization of synthetic,
biologically active, tissue engineering products. We develop and market synthetic-based
biomaterials products for use in spine surgery, the repair of fractures and a broad
range of clinical needs in the trauma, joint reconstruction, revision and extremities
markets. Our near-term commercial business is based on our VITOSS® Bone Graft
Substitute technology platforms, which are designed to address the non-structural
bone graft market by offering synthetic alternatives to the use of autograft or
cadaver-based bone material, and VITAGEL® Surgical Hemostat, which is an adherent
matrix and an impermeable barrier to blood flow. Our longer-term U.S. clinical development
program is focused on our internally developed CORTOSS® Synthetic Cortical Bone
technology platform, which is primarily designed for injections in osteoporotic
spines to treat vertebral compression fractures. We work jointly with Kensey Nash
Corporation to develop and commercialize synthetic-based biomaterial products, we
market VITAGEL under a license granted by Angiotech Pharmaceuticals, Inc., and we
continue to pursue similar relationships with other biomaterials companies.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s
current expectations of future events that involve risks and uncertainties, including,
without limitation, the development, regulatory clearance or approval, demand and
market acceptance of our products, including CORTOSS; the development of our sales
network and other aspects of our business; the closing of the Endoskeleton asset
sale transaction; and other aspects of our business. Such statements are based on
management’s current expectations and are subject to a number of substantial risks
and uncertainties that could cause actual results or timeliness to differ materially
from those addressed in the forward-looking statements. Factors that may cause
such a difference are listed from time to time in reports filed by the Company with
the U.S. Securities and Exchange Commission (SEC), including but not limited to
risks described in our most recently filed Form 10-K under the caption "Risk
Factors”. Further information about these and other relevant risks and uncertainties
may be found in Orthovita’s filings with the SEC, all of which are available from
the SEC as well as other sources. Orthovita undertakes no obligation to publicly
update any forward-looking statements.
Source: Orthovita, Inc.
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2/6/2007
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Orthovita to Present at the First Albany Capital
MALVERN, Pennsylvania, Tuesday, February 6, 2007 – Orthovita, Inc. (NASDAQ: VITA),
a spine and orthopedic biosurgery company, announced today that it will present
at the First Albany Capital 2nd Annual Orthopedics Conference. Antony Koblish,
president and chief executive officer of Orthovita, is scheduled to present on Tuesday,
February 13th, at 1:10 p.m. Pacific Time, at Marina Village, 1936 Quivira Way, San
Diego, CA. This presentation will not be webcast.
About the Company
Orthovita is a spine and orthopedic biosurgery company with proprietary biomaterials
and biologic technologies for the development and commercialization of synthetic,
biologically active, tissue engineering products. We develop and market synthetic-based
biomaterials products for use in spine surgery, the repair of fractures and a broad
range of clinical needs in the trauma, joint reconstruction, revision and extremities
markets. Our near-term commercial business is based on our VITOSS® Bone Graft
Substitute technology platforms, which are designed to address the non-structural
bone graft market by offering synthetic alternatives to the use of autograft or
cadaver-based bone material, and VITAGEL® Surgical Hemostat, which is an adherent
matrix and an impermeable barrier to blood flow. Our longer-term U.S. clinical development
program is focused on our internally developed CORTOSS® Synthetic Cortical Bone
technology platform, which is primarily designed for injections in osteoporotic
spines to treat vertebral compression fractures. We work jointly with Kensey Nash
Corporation to develop and commercialize novel synthetic-based biomaterial products,
we market VITAGEL under a license granted by Angiotech Pharmaceuticals, Inc., and
we continue to pursue similar relationships with other companies in biomaterials.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s
current expectations of future events that involve risks and uncertainties, including,
without limitation, the development, regulatory approval, demand and market acceptance
of our products; the development of our sales network; timing of any submissions
to the FDA related to CORTOSS approval; the adequacy of available resources; and
other aspects of our business. Such statements are based on management’s current
expectations and are subject to a number of substantial risks and uncertainties
that could cause actual results or timeliness to differ materially from those addressed
in the forward-looking statements. Factors that may cause such a difference
are listed from time to time in reports filed by the Company with the U.S. Securities
and Exchange Commission (SEC), including but not limited to risks described in our
most recently filed Form 10-K under the caption "Risks Factors”. Further
information about these and other relevant risks and uncertainties may be found
in Orthovita’s filings with the SEC, all of which are available from the SEC as
well as other sources. Orthovita undertakes no obligation to publicly update any
forward-looking statements.
Source: Orthovita, Inc.
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2/5/2007
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Orthovita Confirms That 510(k) Submission May Be Used To Seek Clearance For CORTOSS®
Bone Augmentation Material For The Treatment Of Vertebral Compression Fractures
MALVERN, Pennsylvania, USA, February 5, 2007 – Orthovita, Inc. (NASDAQ: VITA), a
spine and orthopedic biosurgery company, reported that it received confirmation
from the FDA that a 510(k) submission, accompanied by supporting clinical and preclinical
data, is the appropriate regulatory pathway for CORTOSS® Bone Augmentation Material
for vertebroplasty.
Orthovita is nearing completion of patient enrollment for its pivotal, prospective,
randomized clinical study for CORTOSS® Bone Augmentation Material, which has been
conducted under an FDA Investigational Device Exemption (IDE). The protocol
used in the study was developed in accordance with the FDA’s vertebral compression
fracture guidance document. The study is designed to assess the safety and
efficacy of CORTOSS® for the treatment of osteoporotic vertebral compression fractures
as compared to commercially available polymethylmethacrylate (PMMA) bone cement.
When this pivotal study is completed, approximately 2,500 patients will have been
screened and 255 patients enrolled with a randomization of approximately 2:1 (162
patients treated using CORTOSS and the remaining patients treated using a PMMA bone
cement) at 22 sites. Patients will be followed at intervals up to 24 months
post-procedure. Orthovita plans to engage in further discussions with the
FDA concerning the length of follow up data required for the regulatory submission.
If data from the pivotal study is supportive, Orthovita intends to seek clearance
to market CORTOSS through a 510(k) submission.
“We are very pleased that the regulatory pathway for CORTOSS has been determined
to be the 510(k) process, as opposed to the more involved pre-market application,
or PMA, process,” said Antony Koblish, president and chief executive officer of
Orthovita, Inc. “This development provides clarity on the required process
for submitting our extensive CORTOSS clinical and preclinical data package to the
FDA as we seek to bring an important new medical device option to both physicians
and patients for the treatment of vertebral compression fractures.”
CORTOSS has CE Certification for use in the European Union for screw augmentation
and for vertebral augmentation of VCFs of the spine, which enables it to be sold
in the European Union as well as in other countries that have adopted the European
Union’s regulatory standards. CORTOSS is not approved for use or available
for sale in the United States.
About the Company
Orthovita is a spine and orthopedic biosurgery company with proprietary biomaterials
and biologic technologies for the development and commercialization of synthetic,
biologically active, tissue engineering products. We develop and market synthetic-based
biomaterials products for use in spine surgery, the repair of fractures and a broad
range of clinical needs in the trauma, joint reconstruction, revision and extremities
markets. Our near-term commercial business is based on our VITOSS® Bone Graft
Substitute technology platform, which are designed to address the non-structural
bone graft market by offering synthetic alternatives to the use of autograft or
cadaver-based bone material, and VITAGEL® Surgical Hemostat, which is an adherent
matrix and an impermeable barrier to blood flow. Our longer-term U.S. clinical development
program is focused on our internally developed CORTOSS® Bone Augmentation Material,
which is primarily designed for injections in osteoporotic spines to treat vertebral
compression fractures. We work jointly with Kensey Nash Corporation to develop and
commercialize synthetic-based biomaterial products, we market VITAGEL under a license
granted by Angiotech Pharmaceuticals (US), Inc., and we continue to pursue similar
relationships with other biomaterials companies.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s
current expectations of future events that involve risks and uncertainties, including,
without limitation, the development, regulatory clearance or approval, demand and
market acceptance of our products, including CORTOSS; the timing of any submissions
to the FDA related to CORTOSS clearance or approval; the timing of completion of
enrollment of our CORTOSS U.S. pivotal study; and other aspects of our business.
Such statements are based on management’s current expectations and are subject to
a number of substantial risks and uncertainties that could cause actual results
or timeliness to differ materially from those addressed in the forward-looking statements.
Factors that may cause such a difference are listed from time to time in reports
filed by the Company with the U.S. Securities and Exchange Commission (SEC), including
but not limited to risks described in our most recently filed Form 10-K under the
caption "Risk Factors”. Further information about these and other relevant
risks and uncertainties may be found in Orthovita’s filings with the SEC, all of
which are available from the SEC as well as other sources. Orthovita undertakes
no obligation to publicly update any forward-looking statements.
Source: Orthovita, Inc.
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1/22/2007
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FDA Approves Orthovita's PMA Supplement for the CELLPAKER(R) Plasma Collection System
Used in Conjunction with the VITAGEL(R) Surgical Hemostat
MALVERN, Pennsylvania, USA, Monday, January 22, 2007 – Orthovita, Inc. (NASDAQ:
VITA), a spine and orthopedic biosurgery company, reported today that the U.S. Food
and Drug Administration approved its Pre-Market Approval (PMA) Supplement for the
CELLPAKER® plasma collection system. The new approval permits Orthovita to sell
CELLPAKER product that is manufactured at its subcontractor’s facility.
The CELLPAKER plasma collection system is used in conjunction with Orthovita’s VITAGEL®
Surgical Hemostat product. VITAGEL is a composite liquid hemostat used in
surgical procedures as an adjunct to hemostasis when control of bleeding by ligature
or conventional procedures is ineffective or impractical. VITAGEL stimulates hemostasis
and healing through multiple mechanisms, amplifying the patient’s own biology. Upon
application, VITAGEL works by combining a thrombin/collagen suspension with the
patient’s own plasma. The resultant fibrin/collagen clot stems bleeding and provides
a robust three-dimensional matrix for soft tissue healing.
Orthovita has been distributing VITAGEL and CELLPAKER since January 2005 under a
distribution agreement with Angiotech BioMaterials Corp. (“ABC”). Pursuant
to a March 2006 License Agreement with ABC’s affiliate, Angiotech Pharmaceuticals
(US), Inc., manufacturing obligations for the VITAGEL and CELLPAKER products shifted
from Angiotech to Orthovita. Orthovita commenced manufacturing VITAGEL in
July 2006 (after receiving FDA approval for its Vitagel PMA in June 2006) and will
immediately commence the sale of CELLPAKER manufactured on its behalf under the
new PMA Supplement approval. As a result of Orthovita’s purchase in December
2006 of the profit-sharing royalty rights for VITAGEL and CELLPAKER under the License
Agreement with Angiotech, Orthovita now sells VITAGEL and CELLPAKER on a royalty-free
basis.
About the Company
Orthovita is a spine and orthopedic biosurgery company with proprietary biomaterials
and biologic technologies for the development and commercialization of synthetic,
biologically active, tissue engineering products. We develop and market synthetic-based
biomaterials products for use in spine surgery, the repair of fractures and a broad
range of clinical needs in the trauma, joint reconstruction, revision and extremities
markets. Our near-term commercial business is based on our VITOSS® Bone Graft
Substitute technology platforms, which are designed to address the non-structural
bone graft market by offering synthetic alternatives to the use of autograft or
cadaver-based bone material, and VITAGEL® Surgical Hemostat, which is an adherent
matrix and an impermeable barrier to blood flow. Our longer-term U.S. clinical development
program is focused on our internally developed CORTOSS® Synthetic Cortical Bone
technology platform, which is primarily designed for injections in osteoporotic
spines to treat vertebral compression fractures. We work jointly with Kensey Nash
Corporation to develop and commercialize synthetic-based biomaterial products, we
market VITAGEL under a license granted by Angiotech Pharmaceuticals (US), Inc.,
and we continue to pursue similar relationships with other biomaterials companies.
This press release may contain forward-looking statements regarding Orthovita’s
current expectations of future events that involve risks and uncertainties, including,
without limitation, the development, regulatory approval, demand and market acceptance
of our products; the timing of any submissions to the FDA related to CORTOSS approval;
and other aspects of our business. Such statements are based on management’s current
expectations and are subject to a number of substantial risks and uncertainties
that could cause actual results or timeliness to differ materially from those addressed
in the forward-looking statements. Factors that may cause such a difference
are listed from time to time in reports filed by the Company with the U.S. Securities
and Exchange Commission (SEC), including but not limited to risks described in our
most recently filed Form 10-K under the caption "Risk Factors”. Further
information about these and other relevant risks and uncertainties may be found
in Orthovita’s filings with the SEC, all of which are available from the SEC as
well as other sources. Orthovita undertakes no obligation to publicly update any
forward-looking statements.
Source: Orthovita, Inc.
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1/3/2007
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Orthovita to Present at the 9th Annual Needham & Company, LLC Growth Conference
Contact: Joseph M. Paiva
Orthovita, Inc.
610-640-1775 or 800-676-8482
MALVERN, Pennsylvania, Wednesday, January 3, 2007 – Orthovita, Inc. (NASDAQ: VITA),
a spine and orthopedic biosurgery company, announced today that it will present
at the 9th Annual Needham & Company, LLC Growth Conference. Antony Koblish,
president and chief executive officer of Orthovita, is scheduled to present on Wednesday,
January 10th, at 2:00 p.m. Eastern Time, at The New York Palace Hotel, 455 Madison
Avenue, New York, NY. A webcast of this presentation will be available at
http://www.wsw.com/webcast/needham16/vita
and will be archived at the same URL for 30 days following the conference.
About the Company
Orthovita is a spine and orthopedic biosurgery company with proprietary biomaterials
and biologic technologies for the development and commercialization of synthetic,
biologically active, tissue engineering products. We develop and market synthetic-based
biomaterials products for use in spine surgery, the repair of fractures and a broad
range of clinical needs in the trauma, joint reconstruction, revision and extremities
markets. Our near-term commercial business is based on our VITOSS(R) Bone
Graft Substitute technology platforms, which are designed to address the non-structural
bone graft market by offering synthetic alternatives to the use of autograft or
cadaver-based bone material, and VITAGEL™ Surgical Hemostat, which is an adherent
matrix and an impermeable barrier to blood flow. Our longer-term U.S. clinical development
program is focused on our internally developed CORTOSS(R) Synthetic Cortical Bone
technology platform, which is primarily designed for injections in osteoporotic
spines to treat vertebral compression fractures. We work jointly with Kensey Nash
Corporation to develop and commercialize novel synthetic-based biomaterial products,
we market VITAGEL under a license granted by Angiotech Pharmaceuticals, Inc., and
we continue to pursue similar relationships with other companies in biomaterials.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s
current expectations of future events that involve risks and uncertainties, including,
without limitation, the development, regulatory approval, demand and market acceptance
of our products; the development of our sales network; the adequacy of inventory;
our ability to manufacture products; timing of any submissions to the FDA related
to CORTOSS approval; the adequacy of available resources; and other aspects of our
business. Such statements are based on management’s current expectations and
are subject to a number of substantial risks and uncertainties that could cause
actual results or timeliness to differ materially from those addressed in the forward-looking
statements. Factors that may cause such a difference are listed from time
to time in reports filed by the Company with the U.S. Securities and Exchange Commission
(SEC), including but not limited to risks described in our most recently filed Form
10-K under the caption "Risks Factors”. Further information about these
and other relevant risks and uncertainties may be found in Orthovita’s filings with
the SEC, all of which are available from the SEC as well as other sources. Orthovita
undertakes no obligation to publicly update any forward-looking statements.
Source: Orthovita, Inc.
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12/7/2006
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Orthovita to Participate in the 2006 RBC Capital Markets Healthcare Conference
MALVERN, Pa.--(BUSINESS WIRE)--Dec. 7, 2006--Orthovita, Inc. (NASDAQ: VITA), a spine
and orthopedic biosurgery company, announced today that it will participate in the
2006 RBC Capital Markets Healthcare Conference. Antony Koblish, President and Chief
Executive Officer of Orthovita, is scheduled to participate on the "Motion
& Fusion - The Future of Spinal Surgery" panel on Wednesday, December 13th,
at 1:30 p.m. Eastern Time, at The Westin New York at Times Square Hotel, 270 West
43rd Street, New York, NY. An audio-only webcast of this presentation will be available
at http://www.wsw.com/webcast/rbc62/panel12
and will be archived at the same URL for 30 days following the conference.
About the Company
Orthovita is a spine and orthopedic biosurgery company with proprietary biomaterials
and biologic technologies for the development and commercialization of synthetic,
biologically active, tissue engineering products. We develop and market synthetic-based
biomaterials products for use in spine surgery, the repair of fractures and a broad
range of clinical needs in the trauma, joint reconstruction, revision and extremities
markets. Our near-term commercial business is based on our VITOSS(R) Bone Graft
Substitute technology platforms, which are designed to address the non-structural
bone graft market by offering synthetic alternatives to the use of autograft or
cadaver-based bone material, and VITAGEL(TM) Surgical Hemostat, which is an adherent
matrix and an impermeable barrier to blood flow. Our longer-term U.S. clinical development
program is focused on our internally developed CORTOSS(R) Synthetic Cortical Bone
technology platform, which is primarily designed for injections in osteoporotic
spines to treat vertebral compression fractures. We work jointly with Kensey Nash
Corporation to develop and commercialize novel synthetic-based biomaterial products,
we market VITAGEL under a license granted by Angiotech Pharmaceuticals, Inc., and
we continue to pursue similar relationships with other companies in biomaterials.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita's
current expectations of future events that involve risks and uncertainties, including,
without limitation, the development, regulatory approval, demand and market acceptance
of our products; the development of our sales network; the adequacy of inventory;
our ability to manufacture products; timing of any submissions to the FDA related
to CORTOSS approval; the adequacy of available resources; and other aspects of our
business. Such statements are based on management's current expectations and are
subject to a number of substantial risks and uncertainties that could cause actual
results or timeliness to differ materially from those addressed in the forward-looking
statements. Factors that may cause such a difference are listed from time to time
in reports filed by the Company with the U.S. Securities and Exchange Commission
(SEC), including but not limited to risks described in our most recently filed Form
10-K under the caption "Risks Factors". Further information about these
and other relevant risks and uncertainties may be found in Orthovita's filings with
the SEC, all of which are available from the SEC as well as other sources. Orthovita
undertakes no obligation to publicly update any forward-looking statements.
CONTACT: Orthovita, Inc.
Joseph M. Paiva, 610-640-1775 or 800-676-8482
SOURCE: Orthovita, Inc.
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12/6/2006
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Orthovita Enters into Definitive Agreement to Purchase the VITAGEL™ Profit-Sharing
Royalty Rights From Angiotech Pharmaceuticals (US), Inc.
MALVERN, Pennsylvania, USA, December 6, 2006 – Orthovita, Inc. (NASDAQ: VITA), a
spine and orthopedic biosurgery company, reported that it has entered into a Royalty
Sale Agreement with Angiotech Pharmaceuticals (US), Inc., pursuant to which Orthovita
will purchase the profit-sharing royalty rights for its VITAGEL™ Surgical Hemostat
and CELLPAKER® Collection Device products under its License Agreement with Angiotech.
Under the terms of the Royalty Sale Agreement, Orthovita will pay $9.0 million in
cash to Angiotech, and the License Agreement will be amended and restated to eliminate
Orthovita’s obligations to make royalty payments on VITAGEL and CELLPAKER sales
and meet minimum sales requirements, extend the term of the License Agreement from
December 31, 2014 through July 2017 (which covers the life of the licensed VITAGEL
and CELLPAKER patent portfolio), and eliminate certain termination rights in favor
of Angiotech.
The closing of the royalty purchase transaction is scheduled for December 29, 2006,
subject to the satisfaction of certain closing conditions.
Antony Koblish, President and Chief Executive Officer, said, “The profit-sharing
royalty buyout gives us the potential to increase gross margins on one of our fastest
growing products. We plan to further maximize long-term financial benefits
from VITAGEL sales by improving manufacturing efficiencies for the product.”
About the Company
Orthovita is a spine and orthopedic biosurgery company with proprietary biomaterials
and biologic technologies for the development and commercialization of synthetic,
biologically active, tissue engineering products. We develop and market synthetic-based
biomaterials products for use in spine surgery, the repair of fractures and a broad
range of clinical needs in the trauma, joint reconstruction, revision and extremities
markets. Our near-term commercial business is based on our VITOSS® Bone Graft
Substitute technology platforms, which are designed to address the non-structural
bone graft market by offering synthetic alternatives to the use of autograft or
cadaver-based bone material, and VITAGEL™ Surgical Hemostat, which is an adherent
matrix and an impermeable barrier to blood flow. Our longer-term U.S. clinical development
program is focused on our internally developed CORTOSS® Synthetic Cortical Bone
technology platform, which is primarily designed for injections in osteoporotic
spines to treat vertebral compression fractures. We work jointly with Kensey Nash
Corporation to develop and commercialize synthetic-based biomaterial products, we
market VITAGEL under a license granted by Angiotech Pharmaceuticals (US), Inc.,
and we continue to pursue similar relationships with other biomaterials companies.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s
current expectations of future events that involve risks and uncertainties, including,
without limitation, the closing of the purchase of the royalty rights from Angiotech;
our ability to increase VITAGEL and CELLPAKER gross margins; our ability to improve
manufacturing efficiencies; our ability to manufacture products; the development,
regulatory approval, demand and market acceptance of our products; the development
of our sales network; the adequacy of inventory; timing of any submissions to the
FDA related to CORTOSS approval; capital expenditures; the adequacy of available
resources; and other aspects of our business. Such statements are based on management’s
current expectations and are subject to a number of substantial risks and uncertainties
that could cause actual results or timeliness to differ materially from those addressed
in the forward-looking statements. Factors that may cause such a difference
are listed from time to time in reports filed by the Company with the U.S. Securities
and Exchange Commission (SEC), including but not limited to risks described in our
most recently filed Form 10-K under the caption "Risk Factors”. Further
information about these and other relevant risks and uncertainties may be found
in Orthovita’s filings with the SEC, all of which are available from the SEC as
well as other sources. Orthovita undertakes no obligation to publicly update any
forward-looking statements.
Source: Orthovita, Inc.
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11/29/2006
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Orthovita Announces Underwriters’ Exercise of Over-Allotment Option for 1,119,128
Shares in Connection with Offering of Orthovita Common Stock
For Immediate Release
Contact: Joseph M. Paiva
Orthovita, Inc.
610-640-1775 or 800-676-8482
MALVERN, Pennsylvania, USA, November 29, 2006
Orthovita, Inc. (NASDAQ: VITA), a spine and orthopedic biosurgery company, today
announced that the underwriters of its common stock offering that closed on November
22, 2006 have exercised their over-allotment option with respect to the purchase
of 1,119,128 additional shares of common stock at $3.25 per share. All of
the shares of common stock are being offered by the Company pursuant to an effective
shelf registration statement previously filed with the Securities and Exchange Commission.
The net proceeds to the Company from the exercise of the over-allotment option will
total approximately $3.4 million (after deducting underwriting commissions and estimated
expenses), increasing the total net proceeds to the Company from the offering to
approximately $26.5 million. The purchase of the over-allotment shares is
expected to close on December 1, 2006, subject to customary closing conditions.
UBS Securities LLC acted as the sole book-running manager for the offering and First
Albany Capital acted as co-manager for the offering.
Copies of the final prospectus supplement and accompanying base prospectus can be
obtained from UBS Securities LLC, Prospectus Department, 299 Park Avenue, New York,
New York 10171. This press release does not constitute an offer to sell or
the solicitation of an offer to buy any of the securities nor shall there be any
sale of these securities in any state in which such offer, solicitation or sale
would be unlawful prior to registration or qualification under the securities laws
of any such state.
About the Company
Orthovita is a spine and orthopedic biosurgery company with proprietary biomaterials
and biologic technologies for the development and commercialization of synthetic,
biologically active, tissue engineering products. We develop and market synthetic-based
biomaterials products for use in spine surgery, the repair of fractures and a broad
range of clinical needs in the trauma, joint reconstruction, revision and extremities
markets.
Disclosure Notice
This press release contains forward-looking statements regarding Orthovita’s future
plans. Such statements are based on management’s current expectations and
are subject to a number of substantial risks and uncertainties that could cause
actual results or timeliness to differ materially from those addressed in the forward-looking
statements. Factors that may cause such a difference are listed from time
to time in reports filed by the Company with the U.S. Securities and Exchange Commission
(SEC), including but not limited to risks described in our most recently filed Form
10-K under the caption “Risk Factors”. Further information about these and
other relevant risks and uncertainties may be found in Orthovita’s filings with
the SEC, all of which are available from the SEC as well as other sources. Orthovita
undertakes no obligation to publicly update any forward-looking statements.
Source: Orthovita, Inc.
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11/22/2006
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CORTOSS® Podium Presentation and Poster To Be Presented At Radiological Society
of North America Meeting In Chicago
Orthovita Inc (ticker: VITA, exchange: NASDAQ Stock Exchange (.O)) News Release
- 11/22/2006
----
CORTOSS® Podium Presentation and Poster To Be Presented At Radiological Society
of North America Meeting In Chicago
Prospective Randomized Pivotal Trial Of CORTOSS Versus PMMA In The Treatment Of
Vertebral Compression Fractures; Preliminary Results At A Single Institution Business
Editors/Health/Medical Writers RSNA 2006
MALVERN, Pa.--(BUSINESS WIRE)--Nov. 22, 2006--Orthovita, Inc. (NASDAQ:VITA), a spine
and biosurgery company, reported that H. Paul Hatten, Jr., M.D., from Indian River
Radiology, Vero Beach, Florida, will make a podium presentation of a scientific
paper titled "Prospective Randomized Trial Of CORTOSS Versus PMMA In The Treatment
Of Vertebral Compression Fractures; Preliminary Results At A Single Institution",
and that Phillip Maurer, M.D., from Pennsylvania Hospital, Philadelphia, Pennsylvania,
will present a scientific poster titled "Clinical Experience In Two Pilot Studies
Using CORTOSS(R) For Treating Vertebral Compression Fractures In Vertebroplasty
And Kyphoplasty; 1 To 2 Year Follow-Up Of 40 Patients" at the Radiological
Society of North America (RSNA) meeting being held in Chicago from November 26 through
December 1, 2006.
The podium presentation is on Tuesday, November 28, at 10:30 a.m. in Room N226 and
will cover part of a pivotal study being conducted under an FDA Investigational
Device Exemption (IDE) to assess the safety and efficacy of CORTOSS compared to
commercially available PMMA bone cements. A total of 243 patients are to be enrolled
in the pivotal study with a 2:1 randomization (162 patients treated using CORTOSS
and 81 patients treated using a PMMA bone cement) at 19 sites. Patients are evaluated
at pre-op, post-op, 72 hours, 1 week, 1, 3, 6, 12, and 24 months. Patient outcome
will be assessed by Visual Analogue Scale (VAS), Oswestry Disability Index (ODI),
SF-12 and maintenance of height and alignment at the level(s) treated. Among the
inclusion criteria are a minimum VAS score of 50, a minimum ODI score of 30%, an
osteoporotic compression fracture at one or two levels, presence of edema on MRI
or bone scan and an informed patient consent. Exclusionary criteria include greater
than 70% collapse, canal compromise, neurologic deficit at the level(s) to be treated
or tumors. Post-operative CT and radiographs are being used to assess and quantify
leakage. The results reported in the podium presentation are from the Indian River
Radiology site in Vero Beach, Florida, which is one of approximately 19 clinical
sites involved in the pivotal study.
At the Indian River Radiology site, 46 patients have been enrolled; 27 treated using
CORTOSS and 19 treated using a PMMA bone cement. A total of 59 vertebral levels
have been treated; 36 in the CORTOSS treated group and 23 in the PMMA treated group.
The average age is 77 in the CORTOSS treated group and 78 in the PMMA treated group.
Improvement in VAS and ODI scores was similar for both groups out to 6 months.
The average volume of material injected in the CORTOSS treated group was 1.17 cc
and 2.41 cc in the PMMA treated group. Leakages were observed on post-operative
CT scans and found to be similar in both groups. All extravasations were asymptomatic
with no cardio-pulmonary complications.
"These preliminary results suggest that CORTOSS may provide similar pain relief
compared to PMMA bone cement with approximately 50% less material," said Dr.
Hatten. "This may be due to the distinct interdigitated fill pattern obtained
with CORTOSS, which may reduce the risk of leakage and emboli while employing a
"start-stop" technique and precision delivery."
The scientific poster presentation is on Sunday, November 26, at 12:30 p.m. in Hall
D and will cover a preliminary review of two pilot studies to assess the feasibility
and clinical outcome using CORTOSS in treating osteoporotic vertebral compression
fractures. The two FDA approved pilot IDE studies enrolled 40 patients using CORTOSS
for the treatment of vertebral compression fractures using the vertebroplasty technique
at three centers (20 patients) and the kyphoplasty technique at five centers (20
patients). Treatment was limited to one or two levels from T6 to L5. The objective
was to compare the patients' condition prior to and after treatment, with each patient
serving as his own control.
Of the 20 patients treated using the vertebroplasty technique, eight were male and
twelve were female, with an average age of 72, and 26 vertebrae were treated, with
an average of 2.0 cc injected per vertebra. Of the 20 patients treated using the
kyphoplasty technique, six were male and fourteen were female, with an average age
of 79, and 26 vertebrae were treated, with an average of 4.2 cc per vertebra.
For the patients treated with CORTOSS using the vertebroplasty technique, VAS scores
improved from 73 pre-op to 44 at 1 week, 32 at 1 month, 24.1 at 3 months, 33 at
12 months and 49 at 24 months. Similarly, ODI scores decreased from 52% pre-op to
42% at 1 week, 36% at 1 month, 29% at 3 months, 27% at 12 months and 33 % at 24
months.
For the patients treated with CORTOSS using the kyphoplasty technique, VAS scores
improved from 78 pre-op to 38 at 1 week, 27 at 1 month, 22 at 3 months, 23 at 6
months, 13 at 12 months and 23 at 24 months. Similarly, ODI scores decreased from
61% pre-op to 50% at 1 week, 38% at 1 month, 33% at 3 months, 33% at 6 months 38%
at 12 months and 33% at 24 months.
Leakages were analyzed on post-op CT scans and found to be similar in both groups.
All extravasations were anatomically close to the vertebra and asymptomatic. No
cardiac irregularities or pulmonary emboli were observed. Similar rates of secondary
fractures were observed in each group.
"The preliminary results obtained in these two pilot IDE studies indicate that
CORTOSS may be appropriate for the treatment of osteoporotic vertebral compression
fractures," said Dr. Maurer. "These studies suggest a smaller volume of
CORTOSS provides pain relief, as compared to the volumes reported in the literature
for PMMA."
Other investigators in this study include Hyun Bae, M.D., from The Spine Institute
at Saint John's Health Center, Santa Monica, California; William Beutler, M.D.,
and Walter Peppelman, M.D., from the Pennsylvania Spine Institute, Harrisburg, Pennsylvania;
Raymond Linovitz, M.D., Timothy A. Peppers, M.D., and Erik Westerlund, M.D., from
the CORE Orthopedic Medical Center, Encinitas, California; Isador Lieberman, M.D.,
from the Cleveland Clinic, Cleveland, Ohio; Choll Kim, M.D., from the University
of California San Diego, San Diego, California; and Federico Girardi, M.D., from
The Hospital for Special Surgery, New York, New York.
A prospective, randomized, controlled multi-center IDE study is underway in the
U.S. designed to demonstrate that CORTOSS is safe and effective for the treatment
of osteoporotic vertebral compression fractures. CORTOSS is not available for sale
in the United States and is limited to investigational use.
About the Company
Orthovita is a spine and orthopedic biosurgery company with proprietary biomaterials
and biologic technologies for the development and commercialization of synthetic,
biologically active, tissue engineering products. We develop and market synthetic-based
biomaterials products for use in spine surgery, the repair of fractures and a broad
range of clinical needs in the trauma, joint reconstruction, revision and extremities
markets. Our near-term commercial business is based on our VITOSS(R) Bone Graft
Substitute technology platforms, which are designed to address the non-structural
bone graft market by offering synthetic alternatives to the use of autograft or
cadaver-based bone material, and VITAGEL(TM) Surgical Hemostat, which is an adherent
matrix and an impermeable barrier to blood flow. Our longer-term U.S. clinical development
program is focused on our internally developed CORTOSS(R) Synthetic Cortical Bone
technology platform, which is primarily designed for injections in osteoporotic
spines to treat vertebral compression fractures. We work jointly with Kensey Nash
Corporation to develop and commercialize synthetic-based biomaterial products, we
market VITAGEL under a license granted by Angiotech Pharmaceuticals (US), Inc.,
and we continue to pursue similar relationships with other biomaterials companies.
This press release may contain forward-looking statements regarding Orthovita's
current expectations of future events that involve risks and uncertainties, including,
without limitation, our products; product safety, efficacy, regulatory approval,
development and marketability; any future business relationships; and other aspects
of our business. Such statements are based on management's current expectations
and are subject to a number of substantial risks and uncertainties that could cause
actual results or timeliness to differ materially from those addressed in the forward-looking
statements. Factors that may cause such a difference are listed from time to time
in reports filed by the Company with the U.S. Securities and Exchange Commission
(SEC), including but not limited to risks described in our most recently filed Form
10-K under the caption "Certain Risks Related to Our Business". Further
information about these and other relevant risks and uncertainties may be found
in Orthovita's filings with the SEC, all of which are available from the SEC as
well as other sources. Orthovita undertakes no obligation to publicly update any
forward-looking statements.
CONTACT: Orthovita, Inc.
Joseph M. Paiva, 610-640-1775 or 800-676-8482
SOURCE: Orthovita, Inc.
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11/17/2006
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Orthovita Announces Pricing of Underwritten Offering of Common Stock
MALVERN, Pennsylvania, USA, November 17, 2006 – Orthovita, Inc. (NASDAQ: VITA),
a spine and orthopedic biosurgery company, today announced that it has priced a
firm commitment underwritten offering of 7.7 million shares of its common stock
at a price of $3.25 per share. The Company has also granted to the underwriters
a 30-day option to purchase an additional 1.155 million shares of common stock,
solely for the purpose of covering over-allotments, if any. The closing of
the offering is expected to take place on November 22, 2006, subject to the satisfaction
of customary closing conditions. All of the shares of common stock are being
offered by the Company pursuant to an effective shelf registration statement previously
filed with the Securities and Exchange Commission.
The Company expects to receive net proceeds from the offering of approximately $23.1
million after deducting underwriting commissions and expenses (assuming the underwriters’
over-allotment option is not exercised). The Company anticipates using $9
million of net proceeds from the offering to purchase the profit-sharing royalty
rights for the VITAGEL™ Surgical Hemostat and CELLPAKER® Collection Device products
that it sells under its license agreement with Angiotech Pharmaceuticals (US), Inc.,
and anticipates using the remainder of the net proceeds to fund working capital
and for general corporate purposes, including expansion of manufacturing capacity.
On November 7, 2006, the Company entered into a binding letter of intent with Angiotech
to purchase the profit-sharing royalty rights for the VITAGEL and CELLPAKER products
sold by it under its license agreement with Angiotech.
UBS Securities LLC acted as the sole book-running manager for the offering and First
Albany Capital acted as co-manager for the offering.
Copies of the final prospectus supplement and accompanying base prospectus can obtained
from UBS Securities LLC, Prospectus Department, 299 Park Avenue, New York, New York
10171. This press release does not constitute an offer to sell or the solicitation
of an offer to buy any of the securities nor shall there be any sale of these securities
in any state in which such offer, solicitation or sale would be unlawful prior to
registration or qualification under the securities laws of any such state.
About the Company
Orthovita is a spine and orthopedic biosurgery company with proprietary biomaterials
and biologic technologies for the development and commercialization of synthetic,
biologically active, tissue engineering products. We develop and market synthetic-based
biomaterials products for use in spine surgery, the repair of fractures and a broad
range of clinical needs in the trauma, joint reconstruction, revision and extremities
markets.
Disclosure Notice
This press release contains forward-looking statements regarding Orthovita’s anticipated
use of proceeds from the offering. Such statements are based on management’s
current expectations and are subject to a number of substantial risks and uncertainties
that could cause actual results or timeliness to differ materially from those addressed
in the forward-looking statements. Factors that may cause such a difference
are listed from time to time in reports filed by the Company with the U.S. Securities
and Exchange Commission (SEC), including but not limited to risks described in our
most recently filed Form 10-K under the caption “Risk Factors”. Further information
about these and other relevant risks and uncertainties may be found in Orthovita’s
filings with the SEC, all of which are available from the SEC as well as other sources.
Orthovita undertakes no obligation to publicly update any forward-looking statements.
Source: Orthovita, Inc.
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10/30/2006
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Orthovita Reports 2006 Third Quarter Financial
Results
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11/8/2006
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Orthovita Enters into Binding Letter of Intent to Purchase the VITAGEL(TM) Profit-Sharing
Royalty Rights From Angiotech Pharmaceuticals (US), Inc.
Orthovita Enters into Binding Letter of Intent to Purchase the VITAGEL(TM) Profit-Sharing
Royalty Rights From Angiotech Pharmaceuticals (US), Inc.
MALVERN, Pa., Nov 08, 2006 (BUSINESS WIRE) -- Orthovita, Inc. (NASDAQ: VITA), a
spine and orthopedic biosurgery company, reported that it has entered into a binding
letter of intent to purchase the profit-sharing royalty rights for its VITAGEL(TM)
Surgical Hemostat and CELLPAKER(R) Collection Device products under its license
agreement with Angiotech Pharmaceuticals (US), Inc. Angiotech Pharmaceuticals (US),
Inc. is a subsidiary of Angiotech Pharmaceuticals, Inc. (NASDAQ: ANPI). VITAGEL
is approved for use in conjunction with CELLPAKER. Under the provisions of the binding
letter of intent, Orthovita will pay $9.0 million in cash to Angiotech, subject
to the satisfaction of financing and other closing conditions and the negotiation
and execution of a definitive agreement. The binding letter of intent also provides
for the extension of the term of the license agreement from December 31, 2014 through
July 2017, which covers the life of the licensed VITAGEL and CELLPAKER patent portfolio.
Product sales under Orthovita's VITAGEL product platform were $5.6 million for the
nine months ended September 30, 2006, an increase of $3.6 million, or 178%, over
the same period in 2005. VITAGEL sales accounted for 17% of Orthovita's total product
sales for the nine months ended September 30, 2006. The purchase of the profit-sharing
royalty rights is expected to enable Orthovita to increase its gross margins on
product sales of VITAGEL and CELLPAKER.
The license agreement with Angiotech currently provides for Orthovita to pay a royalty
based on a share of profit, as defined in the license agreement, on VITAGEL and
CELLPAKER product sales. For the third quarter of 2006, the royalty was approximately
7% of VITAGEL and CELLPAKER product sales. Orthovita began manufacturing VITAGEL
in July 2006 and is awaiting FDA action on its application to manufacture CELLPAKER.
The purchase of the royalty arrangement, if completed, will give Orthovita a royalty-free
license to sell and manufacture VITAGEL and CELLPAKER and enable it to retain for
itself all profits on these product sales.
About the Company
Orthovita is a spine and orthopedic biosurgery company with proprietary biomaterials
and biologic technologies for the development and commercialization of synthetic,
biologically active, tissue engineering products. We develop and market synthetic-based
biomaterials products for use in spine surgery, the repair of fractures and a broad
range of clinical needs in the trauma, joint reconstruction, revision and extremities
markets. Our near-term commercial business is based on our VITOSS(R) Bone Graft
Substitute technology platforms, which are designed to address the non-structural
bone graft market by offering synthetic alternatives to the use of autograft or
cadaver-based bone material, and VITAGEL(TM) Surgical Hemostat, which is an adherent
matrix and an impermeable barrier to blood flow. Our longer-term U.S. clinical development
program is focused on our internally developed CORTOSS(R) Synthetic Cortical Bone
technology platform, which is primarily designed for injections in osteoporotic
spines to treat vertebral compression fractures. We work jointly with Kensey Nash
Corporation to develop and commercialize synthetic-based biomaterial products, we
market VITAGEL under a license granted by Angiotech Pharmaceuticals (US), Inc.,
and we continue to pursue similar relationships with other biomaterials companies.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita's
current expectations of future events that involve risks and uncertainties, including,
without limitation, the closing of the purchase of the royalty rights from Angiotech,
our ability to raise sufficient funds to complete the purchase of Angiotech's royalty
rights, our ability to increase VITAGEL and CELLPAKER gross margins, the development,
regulatory approval, demand and market acceptance of our products, the development
of our sales network and other aspects of our business, our ability to manufacture
products, the adequacy of inventory, timing of any submissions to the FDA related
to CORTOSS approval, capital expenditures, future financing and liquidity, uses
of cash, expected sales product mix and related margins, and the adequacy of available
resources. Such statements are based on management's current expectations and are
subject to a number of substantial risks and uncertainties that could cause actual
results or timeliness to differ materially from those addressed in the forward-looking
statements. Factors that may cause such a difference are listed from time to time
in reports filed by the Company with the U.S. Securities and Exchange Commission
(SEC), including but not limited to risks described in our most recently filed Form
10-K under the caption "Risk Factors". Further information about these
and other relevant risks and uncertainties may be found in Orthovita's filings with
the SEC, all of which are available from the SEC as well as other sources. Orthovita
undertakes no obligation to publicly update any forward-looking statements.
SOURCE: Orthovita, Inc.
Orthovita, Inc.
About the Company
Orthovita is a spine and orthopedic biosurgery company with proprietary biomaterials
and biologic technologies for the development and commercialization of synthetic,
biologically active, tissue engineering products. We develop and market synthetic-based
biomaterials products for use in spine surgery, the repair of fractures and a broad
range of clinical needs in the trauma, joint reconstruction, revision and extremities
markets. Our near-term commercial business is based on our VITOSS Bone Graft
Substitute technology platforms, which are designed to address the non-structural
bone graft market by offering synthetic alternatives to the use of autograft or
cadaver-based bone material, and VITAGEL™ Surgical Hemostat, which is an adherent
matrix and an impermeable barrier to blood flow. Our longer-term U.S. clinical development
program is focused on our internally developed CORTOSS Synthetic Cortical Bone technology
platform, which is primarily designed for injections in osteoporotic spines to treat
vertebral compression fractures. We work jointly with Kensey Nash Corporation to
develop and commercialize novel synthetic-based biomaterial products, we market
VITAGEL under a license granted by Angiotech Pharmaceuticals, Inc., and we continue
to pursue similar relationships with other companies in biomaterials.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s
current expectations of future events that involve risks and uncertainties, including,
without limitation, the development, regulatory approval and market acceptance of
our products, the development of our sales network and other aspects of our business,
our ability to manufacture products, timing and expected results of our pivotal
U.S. clinical trial for CORTOSS, and timing of any submissions to the FDA related
to CORTOSS approval. Such statements are based on management’s current expectations
and are subject to a number of substantial risks and uncertainties that could cause
actual results or timeliness to differ materially from those addressed in the forward-looking
statements. Factors that may cause such a difference are listed from time
to time in reports filed by the Company with the U.S. Securities and Exchange Commission
(SEC), including but not limited to risks described in our most recently filed Form
10-K under the caption "Certain Risks Related to Our Business”. Further
information about these and other relevant risks and uncertainties may be found
in Orthovita’s filings with the SEC, all of which are available from the SEC as
well as other sources. Orthovita undertakes no obligation to publicly update any
forward-looking statements.
Source: Orthovita, Inc.
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10/26/2006
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Orthovita Schedules Third Quarter 2006 Financial Results Conference Call
MALVERN, Pennsylvania, USA, Thursday, October 26, 2006
Orthovita, Inc. (NASDAQ: VITA), a spine and orthopedic biosurgery company, will
hold a conference call on Tuesday, October 31, 2006, at 8:30 a.m. ET, to review
and discuss its financial results for the third quarter 2006. Antony Koblish,
president and chief executive officer, and Joseph M. Paiva, chief financial officer
of Orthovita, will host the call.
The phone number to join the conference call from within the U.S. is (888) 815-2919,
and from outside the U.S. is (706) 643-3675. The conference identification
number is 8401845. Participants should dial in ten minutes prior to the scheduled
start time for the conference call.
A replay of the conference call will be available for one week beginning October
31, 2006, at 11:30 a.m. ET, and ending November 7, 2006, at 11:59 p.m. ET.
You may listen to the replay by dialing within the U.S. (800) 642-1687 or by dialing
from outside the U.S. (706) 645-9291. The replay identification number is
8401845.
About the Company
Orthovita is a spine and orthopedic biosurgery company with proprietary biomaterials
and biologic technologies for the development and commercialization of synthetic,
biologically active, tissue engineering products. We develop and market synthetic-based
biomaterials products for use in spine surgery, the repair of fractures and a broad
range of clinical needs in the trauma, joint reconstruction, revision and extremities
markets. Our near-term commercial business is based on our VITOSS Bone Graft
Substitute technology platforms, which are designed to address the non-structural
bone graft market by offering synthetic alternatives to the use of autograft or
cadaver-based bone material, and VITAGEL™ Surgical Hemostat, which is an adherent
matrix and an impermeable barrier to blood flow. Our longer-term U.S. clinical development
program is focused on our internally developed CORTOSS Synthetic Cortical Bone technology
platform, which is primarily designed for injections in osteoporotic spines to treat
vertebral compression fractures. We work jointly with Kensey Nash Corporation to
develop and commercialize novel synthetic-based biomaterial products, we market
VITAGEL under a license granted by Angiotech Pharmaceuticals, Inc., and we continue
to pursue similar relationships with other companies in biomaterials.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita’s
current expectations of future events that involve risks and uncertainties, including,
without limitation, the development, regulatory approval and market acceptance of
our products, the development of our sales network and other aspects of our business,
our ability to manufacture products, timing and expected results of our pivotal
U.S. clinical trial for CORTOSS, and timing of any submissions to the FDA related
to CORTOSS approval. Such statements are based on management’s current expectations
and are subject to a number of substantial risks and uncertainties that could cause
actual results or timeliness to differ materially from those addressed in the forward-looking
statements. Factors that may cause such a difference are listed from time
to time in reports filed by the Company with the U.S. Securities and Exchange Commission
(SEC), including but not limited to risks described in our most recently filed Form
10-K under the caption "Certain Risks Related to Our Business”. Further
information about these and other relevant risks and uncertainties may be found
in Orthovita’s filings with the SEC, all of which are available from the SEC as
well as other sources. Orthovita undertakes no obligation to publicly update any
forward-looking statements.
Source: Orthovita, Inc.
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10/9/2006
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First U.S. Presentation Of CORTOSS® IDE Pivotal Clinical Preliminary Data To Be
Presented In A Poster At The Congress Of Neurological Surgeons In Chicago
MALVERN, Pennsylvania, USA, Monday, October 9, 2006 – Orthovita,
Inc. (NASDAQ: VITA), a developer of orthopedic biomaterials, reported that Hyun
Bae, M.D., from The Spine Institute at Saint John’s Health Center, Santa Monica,
California, will present a scientific poster titled “Prospective Randomized Trial
Of CORTOSS® Versus PMMA In The Treatment Of Vertebral Compression Fractures; Preliminary
Results At A Single Institution” at the Congress of Neurological Surgeons (CNS)
meeting being held in Chicago from October 7 through October 12, 2006.
The results reported in the scientific paper cover 38 patients enrolled at this
site; 22 treated with CORTOSS and 14 treated with PMMA. A total of 55 levels
were treated; 35 in the CORTOSS treated group and 20 in the PMMA treated group.
The average age is 81 for both the CORTOSS treated group and the PMMA treated group.
Improvement in VAS and ODI scores was similar for both groups out to 6 months. The
average volume of material injected was 2.3 cc in the CORTOSS treated group and
4.6 cc in the PMMA treated group. Leakages were asymptomatic and similar in both
groups with no cardiac irregularities or pulmonary emboli.
“The preliminary results suggest that CORTOSS, with much lower injection volume
per treated vertebra, may provide similar pain relief compared to PMMA bone cement,”
said Dr. Bae. “These results are consistent with those obtained in the prospective
vertebroplasty study using CORTOSS conducted in Europe.”
Ben P. Pradhan, MD, from The Spine Institute at Saint John’s Health Center, Santa
Monica, California, also contributed to this scientific paper.
The purpose of this study is to assess the safety and efficacy of CORTOSS for the
treatment of osteoporotic vertebral compression fractures as compared to commercially
available PMMA bone cement via an FDA IDE pivotal, prospective, randomized clinical
study. The total number of patients to be enrolled in the study is 243 with
a 2:1 randomization (162 CORTOSS and 81 PMMA) at 19 sites. Patients are being evaluated
at the following time points: pre-op, post-op, 72 hours, 1 week, 1, 3, 6, 12, and
24 months. Patient outcome will be assessed by Visual Analogue Scale (VAS), Oswestry
Disability Index (ODI), SF-12 and maintenance of height and alignment at the level(s)
treated. Among the inclusion criteria are a minimum VAS score of 50, a minimum
ODI score of 30%, an osteoporotic compression fracture at one or two levels, presence
of edema on MRI or bone scan and an informed patient consent. Among the exclusion
criteria are a greater than 70% collapse, spinal canal compromise, neurologic deficit
at the level(s) to be treated or tumors. CORTOSS is not available for sale
in the United States and is limited to investigational use.
About the Company
Orthovita is a biosurgery company with proprietary biomaterial technologies for
the development and commercialization of synthetic, biologically active, tissue
engineering products for orthopedic and neurosurgical applications. Our products
are used in the regeneration of bone and soft tissue. Our near-term commercial
business is based on our VITOSS? Bone Graft Substitute technology platforms, which
are designed to address the non-structural bone graft market by offering synthetic
alternatives to the use of autograft or cadaver-derived bone material to meet a
broad range of orthopedic clinical needs in the spine, trauma, joint reconstruction,
revision surgery and extremities markets, and VITAGEL™ Surgical Hemostat, which
is an adherent matrix and an impermeable barrier to blood flow. Our longer-term
U.S. clinical development program is focused on our CORTOSS? Synthetic Cortical
Bone technology platform, which is designed for injections in osteoporotic spines
to treat vertebral compression fractures. Orthovita works jointly with Kensey Nash
Corporation and Angiotech Pharmaceuticals, Inc., to develop and market novel synthetic-based
biomaterial products, and continues to pursue similar relationships with other companies
in biomaterials.
This press release may contain forward-looking statements regarding Orthovita’s
current expectations of future events that involve risks and uncertainties, including,
without limitation, our products, product safety, efficacy, regulatory approval,
development and marketability, any future business relationships and other aspects
of our business. Such statements are based on management’s current expectations
and are subject to a number of substantial risks and uncertainties that could cause
actual results or timeliness to differ materially from those addressed in the forward-looking
statements. Factors that may cause such a difference are listed from time
to time in reports filed by the Company with the U.S. Securities and Exchange Commission
(SEC), including but not limited to risks described in our most recently filed Form
10-K under the caption "Certain Risks Related to Our Business”. Further
information about these and other relevant risks and uncertainties may be found
in Orthovita’s filings with the SEC, all of which are available from the SEC as
well as other sources. Orthovita undertakes no obligation to publicly update any
forward-looking statements.
Source: Orthovita, Inc.
Contact: Joseph M. Paiva
Orthovita, Inc.
610-640-1775 or 800-676-8482
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9/20/2006
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Orthovita to Present at UBS Global Life Sciences Conference
MALVERN, Pa., Sep 20, 2006 (BUSINESS WIRE) -- Orthovita, Inc. (NASDAQ:VITA), a developer
of orthopedic biomaterials, announced today that it will participate as a presenting
company at the UBS Global Life Sciences Conference. Antony Koblish, president and
chief executive officer of Orthovita, is scheduled to present on Monday, September
25th, at 1:30p.m. Eastern Time, at the Grand Hyatt Hotel, Park Avenue at Grand Central,
New York, NY. A live webcast of this presentation will be available at
www.ibb.ubs.com by clicking on the "Conferences" link.
About the Company
Orthovita is a biosurgery company with proprietary biomaterial technologies for
the development and commercialization of synthetic, biologically active, tissue
engineering products for orthopedic and neurosurgical applications. Our products
are used in the regeneration of bone and soft tissue. Our near-term commercial business
is based on our VITOSS(R) Bone Graft Substitute technology platforms, which are
designed to address the non-structural bone graft market by offering synthetic alternatives
to the use of autograft or cadaver-derived bone material to meet a broad range of
orthopedic clinical needs in the spine, trauma, joint reconstruction, revision surgery
and extremities markets, and VITAGEL(TM) Surgical Hemostat, which is an adherent
matrix and an impermeable barrier to blood flow. Our longer-term U.S. clinical development
program is focused on our CORTOSS(R) Synthetic Cortical Bone technology platform,
which is designed for injections in osteoporotic spines to treat vertebral compression
fractures. Orthovita works jointly with Kensey Nash Corporation and Angiotech Pharmaceuticals,
Inc. to develop and market novel synthetic-based biomaterial products, and continues
to pursue similar relationships with other companies in biomaterials.
Cautionary Note Regarding Forward-Looking Statements
This press release may contain forward-looking statements regarding Orthovita's
current expectations of future events that involve risks and uncertainties as listed
from time to time in reports we file with the U.S. Securities and Exchange Commission
(SEC), including but not limited to risks described in our most recently filed Form
10-K and Form 10-Q under the caption "Certain Risks Related to Our Business".
Further information about these and other relevant risks and uncertainties may be
found in Orthovita's filings with the SEC, all of which are available from the SEC
as well as from Orthovita upon request. Orthovita undertakes no obligation to publicly
update any forward-looking statements.
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9/14/2006
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Orthovita Announces First Public Podium Presentation of CORTOSS(R) IDE Pivotal Clinical
Data in the Treatment of Vertebral Compression Fractures at the European Society
of Neuroradiology Meeting in Geneva
MALVERN, Pa.--(BUSINESS WIRE)--Sept. 14, 2006--Orthovita, Inc. (NASDAQ:VITA), a
developer of orthopedic biomaterials, reported that H. Paul Hatten, Jr., M.D., from
Indian River Radiology, Vero Beach, Florida, will make a podium presentation of
a scientific paper titled "Comparison Of CORTOSS(R) To PMMA In The Treatment
Of Vertebral Compression Fractures; Characteristics And Preliminary Clinical Results
At A Single Institution" at the European Society of Neuroradiology meeting
being held in Geneva from September 13 through September 16, 2006. The presentation
of this paper number 39.3 can be seen in the Main Session SS39: Spine Intervention
(Room: ICS/Interventional: 8:30-10:00 a.m.) on Saturday, September 16, 2006 from
8:40-8:50 a.m. Indian River Radiology is one of approximately 19 clinical sites
involved in an ongoing prospective, randomized controlled pivotal study to examine
the use of CORTOSS vertebroplasty in patients with osteoporotic compression fractures.
The results reported in the scientific paper by this clinical site cover 42 patients,
of which 24 patients were treated using CORTOSS and 18 patients were treated using
a PMMA bone cement. A total of 55 levels were treated; 34 in the CORTOSS treated
group and 24 in the PMMA treated group. The average age is 77 in the CORTOSS treated
group and 78 in the PMMA treated group. Improvement in VAS and ODI scores was similar
for both groups out to 6 months. The average volume of material injected in the
CORTOSS treated group was 2.1cc using a low-injection volume Cortoplasty(TM) technique,
as compared to 3.5cc in the PMMA treated group. Leakages were observed on post-operative
CT scans and found to be similar in both groups. All extravasations were asymptomatic
with no cardio-pulmonary complications. These results appear to be consistent with
those obtained in the prospective vertebroplasty study using CORTOSS conducted in
Europe.
"These preliminary results suggest CORTOSS may provide pain relief similar
to PMMA while using about 40% less CORTOSS than PMMA," said Dr. Hatten. "In
my experience performing vertebroplasties using CORTOSS as compared to PMMA, CORTOSS
is easier to use and is superior in its interdigitated fill pattern to provide biomechanical
stabilization of vertebral body compression fractures."
The purpose of this study is to assess the safety and efficacy of CORTOSS compared
to commercially available PMMA bone cement via an FDA IDE pivotal, prospective,
randomized clinical study. A total of 243 patients are to be enrolled in the pivotal
study with a 2:1 randomization (162 patients treated using CORTOSS and 81 patients
treated using a PMMA bone cement) at 19 sites. Patients are evaluated at the following
time points: pre-op, post-op, 72 hours, 1 week, 1, 3, 6, 12, and 24 months. Patient
outcome will be assessed by Visual Analogue Scale (VAS), Oswestry Disability Index
(ODI), SF-12 and maintenance of height and alignment at the level(s) treated. Among
the inclusion criteria are a minimum VAS score of 50, a minimum ODI score of 30%,
an osteoporotic compression fracture at one or two levels, presence of edema on
MRI or bone scan and an informed patient consent. Among the exclusion criteria are
greater than 70% collapse, canal compromise, neurologic deficit at the level(s)
to be treated, and tumors. Post-operative CT and radiographs are being used to assess
and quantify leakage.
A prospective, randomized, controlled multi-center IDE study underway in the U.S.
is designed to demonstrate that CORTOSS is safe and effective for the treatment
of osteoporotic vertebral compression fractures. CORTOSS is not available for sale
in the United States and is limited to investigational use.
About the Company
Orthovita is a biosurgery company with proprietary biomaterial technologies for
the development and commercialization of synthetic, biologically active, tissue
engineering products for orthopedic and neurosurgical applications. Our products
are used in the regeneration of bone and soft tissue. Our near-term commercial business
is based on our VITOSS(R) Bone Graft Substitute technology platforms, which are
designed to address the non-structural bone graft market by offering synthetic alternatives
to the use of autograft or cadaver-derived bone material to meet a broad range of
orthopedic clinical needs in the spine, trauma, joint reconstruction, revision surgery
and extremities markets, and VITAGEL(TM) Surgical Hemostat, which is an adherent
matrix and an impermeable barrier to blood flow. Our longer-term U.S. clinical development
program is focused on our CORTOSS(R) Synthetic Cortical Bone technology platform,
which is designed for injections in osteoporotic spines to treat vertebral compression
fractures. Orthovita works jointly with Kensey Nash Corporation and Angiotech Pharmaceuticals,
Inc., to develop and market novel synthetic-based biomaterial products, and continues
to pursue similar relationships with other companies in biomaterials.
This press release may contain forward-looking statements regarding Orthovita's
current expectations of future events that involve risks and uncertainties, including,
without limitation, our products and other aspects of our business. Such statements
are based on management's current expectations and are subject to a number of substantial
risks and uncertainties that could cause actual results or timeliness to differ
materially from those addressed in the forward-looking statements. Factors that
may cause such a difference are listed from time to time in reports filed by the
Company with the U.S. Securities and Exchange Commission (SEC), including but not
limited to risks described in our most recently filed Form 10-K under the caption
"Certain Risks Related to Our Business". Further information about these
and other relevant risks and uncertainties may be found in Orthovita's filings with
the SEC, all of which are available from the SEC as well as other sources. Orthovita
undertakes no obligation to publicly update any forward-looking statements.
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9/12/2006
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Albert J. Pavucek, Jr. Joins Orthovita as Vice President Corporate Controller
MALVERN, Pa., Sep 12, 2006 (BUSINESS WIRE) -- Orthovita, Inc. (NASDAQ:VITA), a developer
of orthopedic biomaterials, reported that Albert J. Pavucek, Jr. joined the company
as Vice President Corporate Controller. In this position, Mr. Pavucek will be responsible
for day-to-day internal accounting operations within the company.
Mr. Pavucek served since 2002 as Vice President, Finance and Operations of PDI,
Inc., a biopharmaceutical commercialization partner. Previously at PDI, Inc., Mr.
Pavucek served as Executive Director, Controller since 2001. Mr. Pavucek served
at Astra Zeneca, L.P. since 1994 in finance and operations roles of increasing responsibility,
cumulating as Sales Force Controller in 1996. Mr. Pavucek is a graduate of Temple
University with Bachelor and Master Degrees in Business Administration and is a
Fellow Alumni of the Wharton School of Business at the University of Pennsylvania.
"We are very pleased to have Al Pavucek join our finance organization,"
said Joseph Paiva, Chief Financial Officer of Orthovita. "Al's broad operating
experience will add to the depth of our management team."
About the Company
Orthovita is a biosurgery company with proprietary biomaterial technologies for
the development and commercialization of synthetic, biologically active, tissue
engineering products for orthopedic and neurosurgical applications. Our products
are used in the regeneration of bone and soft tissue. Our near-term commercial business
is based on our VITOSS(R) Bone Graft Substitute technology platforms, which are
designed to address the non-structural bone graft market by offering synthetic alternatives
to the use of autograft or cadaver-derived bone material to meet a broad range of
orthopedic clinical needs in the spine, trauma, joint reconstruction, revision surgery
and extremities markets, and VITAGEL(TM) Surgical Hemostat, which is an adherent
matrix and an impermeable barrier to blood flow. Our longer-term U.S. clinical development
program is focused on our CORTOSS(R) Synthetic Cortical Bone technology platform,
which is designed for injections in osteoporotic spines to treat vertebral compression
fractures. Orthovita works jointly with Kensey Nash Corporation and Angiotech Pharmaceuticals,
Inc., to develop and market novel synthetic-based biomaterial products, and continues
to pursue similar relationships with other companies in biomaterials.
This press release may contain forward-looking statements regarding Orthovita's
current expectations of future events that involve risks and uncertainties, including,
without limitation, our products and other aspects of our business. Such statements
are based on management's current expectations and are subject to a number of substantial
risks and uncertainties that could cause actual results or timeliness to differ
materially from those addressed in the forward-looking statements. Factors that
may cause such a difference are listed from time to time in reports filed by the
Company with the U.S. Securities and Exchange Commission (SEC), including but not
limited to risks described in our most recently filed Form 10-K under the caption
"Certain Risks Related to Our Business". Further information about these
and other relevant risks and uncertainties may be found in Orthovita's filings with
the SEC, all of which are available from the SEC as well as other sources. Orthovita
undertakes no obligation to publicly update any forward-looking statements.
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8/29/2006
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Orthovita to Present at Thomas Weisel Partners Healthcare Conference
MALVERN, Pa.--(BUSINESS WIRE)--Aug. 29, 2006--Orthovita, Inc. (NASDAQ: VITA), a
developer of orthopedic biomaterials, announced today that it will participate as
a presenting company at the Thomas Weisel Partners Healthcare Conference. Antony
Koblish, president and chief executive officer of Orthovita, is scheduled to present
on Friday, September 8th, at 12:05p.m. Eastern Time, at the Four Seasons Hotel,
200 Boylston Street, Boston, MA. A live webcast of this presentation will be available
at http://www.veracast.com/webcasts/twp/healthcare06/54308266.cfm
and will be archived at the same URL for 30 days following the conference.
About the Company
Orthovita is a biosurgery company with proprietary biomaterial technologies for
the development and commercialization of synthetic, biologically active, tissue
engineering products for orthopedic and neurosurgical applications. Our products
are used in the regeneration of bone and soft tissue. Our near-term commercial business
is based on our VITOSS(R) Bone Graft Substitute technology platforms, which are
designed to address the non-structural bone graft market by offering synthetic alternatives
to the use of autograft or cadaver-derived bone material to meet a broad range of
orthopedic clinical needs in the spine, trauma, joint reconstruction, revision surgery
and extremities markets, and VITAGEL(TM) Surgical Hemostat, which is an adherent
matrix and an impermeable barrier to blood flow. Our longer-term U.S. clinical development
program is focused on our CORTOSS(R) Synthetic Cortical Bone technology platform,
which is designed for injections in osteoporotic spines to treat vertebral compression
fractures. Orthovita works jointly with Kensey Nash Corporation and Angiotech Pharmaceuticals,
Inc. to develop and market novel synthetic-based biomaterial products, and continues
to pursue similar relationships with other companies in biomaterials.
Cautionary Note Regarding Forward-Looking Statements
This press release may contain forward-looking statements regarding Orthovita's
current expectations of future events that involve risks and uncertainties as listed
from time to time in reports we file with the U.S. Securities and Exchange Commission
(SEC), including but not limited to risks described in our most recently filed Form
10-K and Form 10-Q under the caption "Certain Risks Related to Our Business".
Further information about these and other relevant risks and uncertainties may be
found in Orthovita's filings with the SEC, all of which are available from the SEC
as well as from Orthovita upon request. Orthovita undertakes no obligation to publicly
update any forward-looking statements.
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8/3/2006
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Orthovita Reports 2006 Second Quarter Financial Results; Second Quarter 2006 Sales
of $11.2 Million Reflect 32% Growth Over Second Quarter 2005; Year-to-Date June
30, 2006 Sales of $22.0 Million Reflect 34% Growth Over Same Period 2005
MALVERN, Pa.--(BUSINESS WIRE)--Aug. 3, 2006-- Completion of CORTOSS(R) U.S. Pivotal
Clinical Trial Enrollment Expected by 2006 Year End
Orthovita, Inc. (NASDAQ:VITA), a developer of orthopedic biomaterials, reported
financial results for the three and six months ended June 30, 2006. Product sales
for the three months ended June 30, 2006 increased 32% to $11,180,000, as compared
to $8,470,000 for the same period in 2005. Product sales for the six months ended
June 30, 2006 increased 34% to $21,997,000, as compared to $16,356,000 for the same
period in 2005. Sales growth for the reported periods was primarily attributable
to increased sales of our VITOSS(R) FOAM and VITAGEL(TM) product portfolios in the
U.S. as we further develop our U.S. field sales network. Approximately 19% and 18%
of our product sales during the three and six months ended June 30, 2006, respectively,
were from our VITOSS FOAM Pack product introduced during the third quarter of 2005.
Approximately 61% and 60% of our product sales during the three and six months ended
June 30, 2006, respectively, were from products based upon our VITOSS FOAM platform
co-developed with Kensey Nash Corporation, which includes VITOSS FOAM Pack, as compared
to approximately 58% of our product sales during each of the three and six months
ended June 30, 2005. Additionally, VITAGEL, which was launched at the start of 2005,
contributed approximately 17% and 16% of product sales for the three and six months
ended June 30, 2006, respectively, as compared to approximately 8% and 7% of product
sales during the three and six months ended June 30, 2005, respectively.
Gross profit for the three months ended June 30, 2006 was $6,782,000 in comparison
to $5,622,000 for the same quarter in 2005. As a percentage of sales, gross profit
was 61% and 66% for the three months ended June 30, 2006 and 2005, respectively.
Gross profit for the six months ended June 30, 2006 was $14,088,000 in comparison
to $11,011,000 for the same period in 2005. As a percentage of sales, gross profit
was 64% and 67% for the six months ended June 30, 2006 and 2005, respectively. The
lower gross profit percentage for each of the three and six months ended June 30,
2006 is primarily attributable to the shift in product mix toward VITAGEL product
sales, which have a lower gross profit than our other product sales.
"We continue to be pleased with the growth in size and development of our specialized
biosurgery, biomaterials and biologics sales team and with the sales increase for
both the VITOSS FOAM Pack and VITAGEL products. Additionally, patient enrollment
for our pivotal CORTOSS clinical trial has reached 75%. While additional patient
enrollment caused our research & development costs to increase during the second
quarter of 2006, the expense for the CORTOSS clinical program should drop off after
submitting the FDA approval filing, which could occur as early as mid-2007,"
said Antony Koblish, President and CEO of Orthovita. "We look forward to more
detailed discussions during the earnings conference call."
Operating expenses for the three months ended June 30, 2006 and 2005 were $12,110,000
and $8,304,000, respectively. Operating expenses for the three months ended June
30, 2006 include non-cash net compensation expense of $403,000 related to stock
option accounting. These non-cash charges are equivalent to 4% of product sales
for the three month period. For the six months ended June 30, 2006 and 2005, operating
expenses were $23,268,000 and $16,486,000, respectively. Operating expenses for
the six months ended June 30, 2006 include non-cash net compensation expense of
$893,000 related to stock option accounting. These non-cash charges are equivalent
to 4% of product sales for the 2006 six month period.
General & administrative expenses for the three months ended June 30, 2006 increased
to $2,234,000 from $1,697,000 for the same period in 2005, primarily due to increased
headcount, audit related costs and information technology infrastructure related
expenses. General & administrative expenses for the six months ended June 30,
2006 increased to $4,340,000 from $3,413,000 for the same period in 2005, primarily
due to increased headcount, general legal expenses, audit related costs and information
technology infrastructure related expenses.
Selling & marketing expenses were $7,056,000 for the three months ended June
30, 2006, as compared to $4,893,000 for the three months ended June 30, 2005. Selling
& marketing expenses were $14,003,000 for the six months ended June 30, 2006,
as compared to $9,980,000 for the six months ended June 30, 2005. Selling and marketing
expenses increased for the three and six months ended June 30, 2006 primarily due
to higher salary and benefit costs incurred by expanding our field sales team from
35 employees at June 30, 2005 to 69 employees at June 30, 2006 in order to support
the growth of U.S. product sales, as well as higher commissions paid in the U.S.
as a result of increased product sales in 2006.
Research & development expenses increased to $2,820,000 for the three months
ended June 30, 2006 from $1,713,000 for the same period in 2005. Research &
development expenses increased to $4,925,000 for the six months ended June 30, 2006
from $3,093,000 for the same period in 2005. The increase for both the three and
six month periods ended June 30, 2006 was primarily due to costs associated with
our VITAGEL product development and our CORTOSS product development and U.S. clinical
trial.
The net loss for the three months ended June 30, 2006 and 2005 was $5,461,000 and
$2,742,000, respectively. Accordingly, the net loss per common share was $.10 and
$.06 in the periods reported based upon 52,376,000 and 47,869,000 common shares
outstanding, respectively. Excluding the non-cash net compensation expense of $403,000
recorded during the three months ended June 30, 2006, which resulted from the application
of stock option accounting rules effective as of January 1, 2006, the non-GAAP net
loss would have been $5,057,000 or $.10 per common share for the three months ended
June 30, 2006. The net loss for the six months ended June 30, 2006 and 2005 was
$9,388,000 and $5,631,000, respectively. Accordingly, the net loss per common share
was $.18 and $.12 in the periods reported based upon 52,349,000 and 47,853,000 common
shares outstanding, respectively. Excluding the non-cash net compensation expense
of $893,000 recorded during the six months ended June 30, 2006, which resulted from
the application of stock option accounting rules effective as of January 1, 2006,
the non-GAAP net loss would have been $8,495,000 or $.16 per common share for the
six months ended June 30, 2006.
"The net loss for the second quarter was impacted by low absorption of manufacturing
overhead, as well as a reduction in our gross profit margin. Due to the timing of
FDA approval of our VITAGEL manufacturing facility in June, we did not manufacture
VITAGEL product during the second quarter of 2006. In addition, we manufactured
very little VITOSS during the second quarter as we continue to reduce inventory
levels of this product. We expect our overhead absorption to increase during the
second half of 2006 as we commenced the manufacture of VITAGEL in July 2006. We
are pleased with the increase in VITAGEL sales for the three and six month periods
of 2006. However, VITAGEL sales growth has affected our gross margins as it has
a lower margin than our other products. As a result, we may have fluctuating gross
margins from quarter to quarter," said Joseph Paiva, CFO of Orthovita.
Cash, cash equivalents, and investments were $19,254,000 at June 30, 2006 in comparison
to cash, cash equivalents and investments of $27,672,000 at December 31, 2005. For
the six months ended June 30, 2006, the net cash and cash equivalents used in operating
activities were $8,202,000 compared to $7,507,000 for the six months ended June
30, 2005. Net cash and cash equivalents used in operating activities for the six
months ended June 30, 2006 increased due to higher operating expenses, and also
included (i) a $573,000 net increase in prepaid revenue interest expense resulting
from the contractually required annual advance payment at the beginning of each
year to Paul Capital Royalty Acquisition Fund, L.P., (ii) a net decrease of $1,304,000
in accounts payable primarily as a result of vendor payments for VITAGEL inventories
purchased during the fourth quarter of 2005, and (iii) a net increase of $405,000
in accounts receivable which is primarily a result of increased product sales, which
amounts were partially offset by a net decrease in inventories of $1,477,000.
CORTOSS U.S. Pivotal Clinical Trial Status
Patient enrollment for the Company's pivotal CORTOSS clinical trial in the U.S.
for vertebroplasty is currently ahead of schedule. As of August 3, 2006, there are
184 patients enrolled in the clinical trial. The final patient enrollment requirements
for the clinical trial are 162 CORTOSS treatment patients and 81 PMMA bone cement
control patients. As of August 3, 2006, the Company has enrolled 108 CORTOSS treatment
patients and 76 PMMA control patients. The Company expects to complete enrollment
of the pivotal CORTOSS trial by the end of 2006.
Non-GAAP Disclosures
This press release includes non-GAAP financial information relating to the Company's
net loss excluding the effect of equity compensation expense resulting from the
Company's adoption of SFAS No. 123R and EITF Issue No. 00-19 in 2006. Management
believes that the presentation of this information will be useful to investors because
the Company did not recognize compensation expense during the three or six month
periods ended June 30, 2005 for options granted to employees and did not record
a mark-to-market adjustment at the end of the quarter for the change in the Black-Scholes
value of our fully-vested non-employee consultant stock options outstanding. Management
believes that a presentation of net loss excluding the effect of such equity compensation
expense will enhance comparability of the Company's financial results for the three
and six month periods ended June 30, 2006 with those of the same periods of the
prior year.
Conference Call
Antony Koblish, President and Chief Executive Officer, and Joseph M. Paiva, Chief
Financial Officer of Orthovita, will host a conference call at 8:30 a.m. Eastern
time on August 4, 2006 to review and discuss the second quarter 2006 financial results.
The phone number to join the conference call from within the U.S. is (888) 815-2919,
and from outside the U.S. is (706) 643-3675; the conference identification number
is 2836509. Listeners are advised to dial in ten minutes prior to the scheduled
start time for the conference call. The replay of the conference call will be available
for one week beginning August 4, 2006, at 11:30 a.m. Eastern time, and ending August
11, 2006, at 11:59 p.m. Eastern time. You may listen to the replay by dialing within
the U.S. (800) 642-1687 or by dialing from outside the U.S. (706) 645-9291. The
replay identification number is 2836509.
About the Company
Orthovita is a biomaterials company with proprietary technologies for the development
and commercialization of synthetic, biologically active, tissue engineering products
for orthopedic and neurosurgical applications. Our products are used in the regeneration
of bone and soft tissue. Our near-term commercial business is based on our VITOSS(R)
Bone Graft Substitute technology platforms, which are designed to address the non-structural
bone graft market by offering synthetic alternatives to the use of autograft or
cadaver-derived bone material to meet a broad range of orthopedic clinical needs
in the spine, trauma, joint reconstruction, revision surgery and extremities markets,
and VITAGEL(TM) Surgical Hemostat, which is an adherent matrix and an impermeable
barrier to blood flow. Our longer-term U.S. clinical development program is focused
on our CORTOSS(R) Synthetic Cortical Bone technology platform, which is designed
for injections in osteoporotic spines to treat vertebral compression fractures.
Orthovita works jointly with Kensey Nash Corporation and Angiotech Pharmaceuticals,
Inc. to develop and market novel synthetic-based biomaterial products, and continues
to pursue similar relationships with other companies in biomaterials.
Disclosure Notice
This press release may contain forward-looking statements regarding Orthovita's
current expectations of future events that involve risks and uncertainties, including,
without limitation, the development, regulatory approval and market acceptance of
our products, the development of our sales network and other aspects of our business,
our ability to manufacture products, the adequacy of inventory, timing and expected
results of our pivotal U.S. clinical trial for CORTOSS, timing of any submissions
to the FDA related to CORTOSS approval, capital expenditures, future financing and
liquidity, uses of cash, expected sales product mix and related margins, equity
compensation expense and the adequacy of available resources. Such statements are
based on management's current expectations and are subject to a number of substantial
risks and uncertainties that could cause actual results or timeliness to differ
materially from those addressed in the forward-looking statements. Factors that
may cause such a difference are listed from time to time in reports filed by the
Company with the U.S. Securities and Exchange Commission (SEC), including but not
limited to risks described in our most recently filed Form 10-K under the caption
"Certain Risks Related to Our Business". Further information about these
and other relevant risks and uncertainties may be found in Orthovita's filings with
the SEC, all of which are available from the SEC as well as other sources. Orthovita
undertakes no obligation to publicly update any forward-looking statements.
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8/22/2006
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Orthovita to Present at Roth Capital Partners 2006 NY Conference
MALVERN, Pa.--(BUSINESS WIRE)--Aug. 22, 2006--Orthovita, Inc. (NASDAQ:VITA), a developer
of orthopedic biomaterials, announced today that it will participate as a presenting
company at the Roth Capital Partners 2006 NY Conference. Antony Koblish, president
and chief executive officer of Orthovita, is scheduled to present on Thursday, September
7th, at 2:00 p.m. Eastern Time, at the Westin New York at Times Square, 270 West
43rd Street, New York, NY. A live webcast of this presentation will be available
at http://www.wsw.com/webcast/roth8/vita/
and will be archived at the same URL for 90 days following the conference.
About the Company
Orthovita is a biomaterials company with proprietary technologies for the development
and commercialization of synthetic, biologically active, tissue engineering products
for orthopedic and neurosurgical applications. Our products are used in the regeneration
of bone and soft tissue. Our near-term commercial business is based on our VITOSS(R)
Bone Graft Substitute technology platforms, which are designed to address the non-structural
bone graft market by offering synthetic alternatives to the use of autograft or
cadaver-derived bone material to meet a broad range of orthopedic clinical needs
in the spine, trauma, joint reconstruction, revision surgery and extremities markets,
and VITAGEL(TM) Surgical Hemostat, which is an adherent matrix and an impermeable
barrier to blood flow. Our longer-term U.S. clinical development program is focused
on our CORTOSS(R) Synthetic Cortical Bone technology platform, which is designed
for injections in osteoporotic spines to treat vertebral compression fractures.
Orthovita works jointly with Kensey Nash Corporation and Angiotech Pharmaceuticals,
Inc. to develop and market novel synthetic-based biomaterial products, and continues
to pursue similar relationships with other companies in biomaterials.
Cautionary Note Regarding Forward-Looking Statements
This press release may contain forward-looking statements regarding Orthovita's
current expectations of future events that involve risks and uncertainties as listed
from time to time in reports we file with the U.S. Securities and Exchange Commission
(SEC), including but not limited to risks described in our most recently filed Form
10-K and Form 10-Q under the caption "Certain Risks Related to Our Business".
Further information about these and other relevant risks and uncertainties may be
found in Orthovita's filings with the SEC, all of which are available from the SEC
as well as from Orthovita upon request. Orthovita undertakes no obligation to publicly
update any forward-looking statements.
CONTACT: Orthovita, Inc.
Joseph M. Paiva, 610-640-1775 or 800-676-8482
SOURCE: Orthovita, Inc.
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7/28/2006
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Orthovita Schedules Second Quarter 2006 Financial Results Conference Call
MALVERN, Pa.--(BUSINESS WIRE)--July 28, 2006--Orthovita, Inc. (NASDAQ:VITA), a developer
of orthopedic biomaterials, will hold a conference call on Friday, August 4, 2006,
at 8:30 a.m. ET, to review and discuss its financial results for the second quarter
2006. Antony Koblish, President and Chief Executive Officer, and Joseph M. Paiva,
Chief Financial Officer of Orthovita, will host the call.
The phone number to join the conference call from within the U.S. is (888) 815-2919,
and from outside the U.S. is (706) 643-3675. The conference identification number
is 2836509. Participants should dial in ten minutes prior to the scheduled start
time for the conference call.
A replay of the conference call will be available for one week beginning August
4, 2006, at 11:30 a.m. ET, and ending August 11, 2006, at 11:59 p.m. ET. You may
listen to the replay by dialing within the U.S. (800) 642-1687 or by dialing from
outside the U.S. (706) 645-9291. The replay identification number is 2836509.
About the Company
Orthovita is a biomaterials company with proprietary technologies for the development
and commercialization of synthetic, biologically active, tissue engineering products
for orthopedic and neurosurgical applications. Our products are used in the regeneration
of bone and soft tissue healing. Our near-term commercial business is based on our
internally developed VITOSS(R) Bone Graft Substitute technology platforms, which
are designed to address the non-structural bone graft market by offering synthetic
alternatives to the use of autograft or cadaver-derived bone material to meet a
broad range of orthopedic clinical needs in the spine, trauma, joint reconstruction,
revision surgery and extremities markets, and VITAGEL(TM) Surgical Hemostat, which
is an adherent matrix and an impermeable barrier to blood flow. Our longer-term
U.S. clinical development program is focused on our internally developed CORTOSS(R)
Synthetic Cortical Bone technology platform, which is designed for injections in
osteoporotic spines to treat vertebral compression fractures. Orthovita works jointly
with Kensey Nash Corporation and Angiotech Pharmaceuticals, Inc., to develop and
market synthetic-based biomaterial products, and continues to pursue similar relationships
with other companies in biomaterials.
Cautionary Note Regarding Forward-Looking Statements
This press release may contain forward-looking statements regarding Orthovita's
current expectations of future events that involve risks and uncertainties as listed
from time to time in reports we file with the U.S. Securities and Exchange Commission
(SEC), including but not limited to risks described in our most recently filed Form
10-K and Form 10-Q under the caption "Certain Risks Related to Our Business".
Further information about these and other relevant risks and uncertainties may be
found in Orthovita's filings with the SEC, all of which are available from the SEC
as well as from Orthovita upon request. Orthovita undertakes no obligation to publicly
update any forward-looking statements.
CONTACT: Orthovita, Inc.
Joseph M. Paiva, 610-640-1775 or 800-676-8482
SOURCE: Orthovita, Inc.
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6/16/2006
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Orthovita Receives FDA Approval to Market its VITAGEL(TM) Surgical Hemostat
MALVERN, Pa.--(BUSINESS WIRE)--June 16, 2006--Orthovita, Inc. (NASDAQ NM:VITA),
a developer of orthopedic biomaterials, reported today that it has obtained pre-market
approval (PMA) from the U.S. Food and Drug Administration to market its VITAGEL(TM)
surgical hemostat. The new approval permits Orthovita to sell VITAGEL surgical hemostat
manufactured at its Malvern, Pennsylvania facility. Orthovita has already manufactured
three lots of VITAGEL at its facility and will begin shipping and selling this product
immediately.
"A high level of coordination and performance was required throughout our organization
to manage existing VITAGEL supply and obtain the pre-market approval within a short
time frame," said Antony Koblish, President and Chief Executive Officer of
Orthovita. "I am very pleased and proud of our team's performance, particularly
from our regulatory affairs, quality and manufacturing groups. We are looking forward
to now applying all our energy to driving VITAGEL sales growth."
VITAGEL is a composite liquid hemostat used in surgical procedures as an adjunct
to hemostasis when control of bleeding by ligature or conventional procedures is
ineffective or impractical. VITAGEL stimulates hemostasis and healing through multiple
mechanisms, amplifying the patient's own biology. VITAGEL is approved for use only
in conjunction with the CELLPAKER(R) plasma collection system. Upon application,
VITAGEL works by combining a thrombin/collagen suspension with the patient's own
plasma. The resultant fibrin/collagen clot stems bleeding and provides a robust
three-dimensional matrix for soft tissue healing.
Orthovita has been distributing VITAGEL and CELLPAKER since January 2005 under a
distribution agreement with Angiotech BioMaterials Corp. Pursuant to a March 2006
License Agreement, manufacturing obligations for the VITAGEL and CELLPAKER products
shifted from Angiotech to Orthovita. Prior to entering into the License Agreement,
Orthovita had purchased from Angiotech all of its existing VITAGEL and CELLPAKER
inventory that had been manufactured by or on behalf of Angiotech. Of this inventory
purchased from Angiotech, Orthovita believes that it has sufficient CELLPAKER inventory
remaining to meet sales demand through the end of 2006. Orthovita will immediately
commence the sale of VITAGEL with this existing inventory while simultaneously pursuing
pre-marketing approval for the manufacture of the CELLPAKER system.
About the Company
Orthovita is a biomaterials company with proprietary technologies for the development
and commercialization of synthetic, biologically active, tissue engineering products
for orthopedic and neurosurgical applications. Our products are used in the regeneration
of bone and soft tissue. Our near-term commercial business is based on our VITOSS(R)
Bone Graft Substitute technology platforms, which are designed to address the non-structural
bone graft market by offering synthetic alternatives to the use of autograft or
cadaver-derived bone material to meet a broad range of orthopedic clinical needs
in the spine, trauma, joint reconstruction, revision surgery and extremities markets,
and VITAGEL(TM) Surgical Hemostat, which is an adherent matrix and an impermeable
barrier to blood flow. Our longer-term U.S. clinical development program is focused
on our CORTOSS(R) Synthetic Cortical Bone technology platform, which is designed
for injections in osteoporotic spines to treat vertebral compression fractures.
Orthovita works jointly with Kensey Nash Corporation and Angiotech Pharmaceuticals,
Inc., to develop and market novel synthetic-based biomaterial products, and continues
to pursue similar relationships with other companies in biomaterials.
This press release contains forward-looking statements that address, among other
things, market acceptance of Orthovita's products and their use in approved applications,
regulatory approval for our products and the manufacture of our products, existing
inventory amounts of our products, our strategic relationships and other aspects
of our business. Such statements are based on management's current expectations
and are subject to a number of substantial risks and uncertainties that could cause
actual results or timeliness to differ materially from those addressed in the forward-looking
statements. Factors that may cause such a difference are listed from time to time
in reports filed by Orthovita with the U.S. Securities and Exchange Commission (SEC),
including but not limited to risks described in our most recently filed Form 10-K
under the caption "Certain Risks Related to Our Business". Further information
about these and other relevant risks and uncertainties may be found in Orthovita's
filings with the SEC, all of which are available from the SEC as well as other sources.
Orthovita undertakes no obligation to publicly update any forward-looking statements.
CONTACT: Orthovita, Inc.
Joseph M. Paiva, 610-640-1775 or 800-676-8482
SOURCE: Orthovita, Inc.
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5/1/2006
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Orthovita Reports First Quarter 2006 Financial Results;
First Quarter 2006 Sales of $10.8 Million Reflect 37% Growth Over First Quarter
2005
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5/12/2006
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Abstract On Augmentation Of Prodisc(R) With CORTOSS(R) To Be Presented At SAS 2006
In Montreal
MALVERN, Pa.--(BUSINESS WIRE)--May 12, 2006--Orthovita, Inc. (NASDAQ NM:VITA), a
developer of orthopedic biomaterials, reported that James Yue, M.D., from Yale University
School of Medicine, will present a scientific paper titled "A prospective,
non-randomized analysis of the adjunctive use of CORTOSS(R) vertebroplasty in lumbar
disc arthroplasty utilizing the Prodisc(R) prosthesis" at the SAS 2006 meeting
being held in Montreal on May 13 at 11:20 a.m. in Session G, Innovative Technologies:
Clinical Papers. The co-authors of this scientific paper include Dr. Rudolf Bertagnoli
who is associated with the St. Elizabeth Klinikum, Straubing, Germany, as well as
Andrea Fenk-Mayer, M.D., Richard Lee, M.D., Jessica Kirk, A.B., and Armin Karg,
A.B.
The expanded use of lumbar disc arthroplasty in osteopenic patients has not been
advised due to the possibility of subsidence/compression fractures. This is because
a significant number of women will develop osteoporosis, which makes them susceptible
to suffering vertebral compression fractures in the future. Given that osteoporosis
is a contra-indication for lumbar total disc arthroplasty, there may be a need for
materials and techniques to prevent and treat subsidence in this patient group.
Accordingly, the objective of the prospective, non-randomized study was to examine
the use of adjunctive CORTOSS vertebroplasty in osteopenic patients undergoing Prodisc-L(R)
surgery. The median age of all patients was 49 years old, and they presented with
symptomatic lumbar degenerative disc disease, with or without radicular pain. Post-operative
follow-up with radiographic analysis was performed at 3, 6 and 12 months. The 35
patients included in the analysis fulfilled all follow-up criteria and underwent
a procedure that included both a Prodisc lumbar disc arthroplasty and an adjunctive
anterior vertebroplasty using CORTOSS bone augmentation material.
Statistically significant improvements in VAS, Oswestry and patient satisfaction
scores occurred 3 months post-op, and these improvements were maintained 12 months
post-op. No additional surgeries were necessary either at the affected or unaffected
levels in vertebroplasty patients. There were no cases where neurologic adverse
effects or hemodynamic or pulmonary instability were experienced. In addition, there
were no cases of subsidence, loosening or migration seen in patients undergoing
adjunctive vertebroplasty.
"Our early results indicate that adjunctive use of CORTOSS vertebroplasty during
lumbar total disc arthroplasty in patients with less than optimal bone density appears
to decrease the risk of subsidence as compared to historical controls," said
Dr. Bertagnoli.
A prospective, randomized, controlled multi-center IDE study is underway in the
U.S. designed to demonstrate that CORTOSS is safe and effective for the treatment
of osteoporotic vertebral compression fractures. CORTOSS is not available for sale
in the United States and is limited to investigational use.
About the Company
Orthovita is a biomaterials company with proprietary technologies for the development
and commercialization of synthetic, biologically active, tissue engineering products
for orthopedic and neurosurgical applications. Our products are used in the regeneration
of bone and soft tissue. Our near-term commercial business is based on our VITOSS(R)
Bone Graft Substitute technology platforms, which are designed to address the non-structural
bone graft market by offering synthetic alternatives to the use of autograft or
cadaver-derived bone material to meet a broad range of orthopedic clinical needs
in the spine, trauma, joint reconstruction, revision surgery and extremities markets,
and VITAGEL(TM) Surgical Hemostat, which is an adherent matrix and an impermeable
barrier to blood flow. Our longer-term U.S. clinical development program is focused
on our CORTOSS(R) Synthetic Cortical Bone technology platform, which is designed
for injections in osteoporotic spines to treat vertebral compression fractures.
Orthovita works jointly with Kensey Nash Corporation and Angiotech Pharmaceuticals,
Inc., to develop and market novel synthetic-based biomaterial products, and continues
to pursue similar relationships with other companies in biomaterials.
This press release may contain forward-looking statements regarding Orthovita's
current expectations of future events that involve risks and uncertainties, including,
without limitations, our products and other aspects of our business. Such statements
are based on management's current expectations and are subject to a number of substantial
risks and uncertainties that could cause actual results or timeliness to differ
materially from those addressed in the forward-looking statements. Factors that
may cause such a difference are listed from time to time in reports filed by the
Company with the U.S. Securities and Exchange Commission (SEC), including but not
limited to risks described in our most recently filed Form 10-K under the caption
"Certain Risks Related to Our Business". Further information about these
and other relevant risks and uncertainties may be found in Orthovita's filings with
the SEC, all of which are available from the SEC as well as other sources. Orthovita
undertakes no obligation to publicly update any forward-looking statements.
CONTACT: Orthovita, Inc.
Joseph M. Paiva, 610-640-1775 or 800-676-8482
SOURCE: Orthovita, Inc.
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6/7/2006
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Orthovita to Present at Pacific Growth Equities 2006 Life Sciences Growth Conference
MALVERN, Pa.--(BUSINESS WIRE)--June 7, 2006--Orthovita, Inc. (NASDAQ NM:VITA), a
leading developer of orthopedic biomaterials, announced today that it will participate
as a presenting company at the Pacific Growth Equities 2006 Life Sciences Growth
Conference. Joseph Paiva, chief financial officer of Orthovita, is scheduled to
present on Tuesday, June 13th, at 1:30 p.m. Pacific Time, at the InterContinental
Mark Hopkins Hotel, Number One Nob Hill, San Francisco, CA. A live webcast of this
presentation will be available at
http://www.corporate-ir.net/ireye/confLobby.zhtml?ticker= VITA&item_id=1315818
(Due to its length, this URL may need to be copied/pasted into your Internet browser's
address field. Remove the extra space if one exists) and will be archived at the
same URL for on-demand listening for one year following the conference.
About the Company
Orthovita is a biomaterials company with proprietary technologies for the development
and commercialization of synthetic, biologically active, tissue engineering products
for orthopedic and neurosurgical applications. Our products are used in the regeneration
of bone and soft tissue healing. Our near-term commercial business is based on our
internally developed VITOSS(R) Bone Graft Substitute technology platforms, which
are designed to address the non-structural bone graft market by offering synthetic
alternatives to the use of autograft or cadaver-derived bone material to meet a
broad range of orthopedic clinical needs in the spine, trauma, joint reconstruction,
revision surgery and extremities markets, and VITAGEL(TM) Surgical Hemostat, which
is an adherent matrix and an impermeable barrier to blood flow. Our longer-term
U.S. clinical development program is focused on our internally developed CORTOSS(R)
Synthetic Cortical Bone technology platform, which is designed for injections in
osteoporotic spines to treat vertebral compression fractures. Orthovita works jointly
with Kensey Nash Corporation and Angiotech Pharmaceuticals, Inc., to develop and
market synthetic-based biomaterial products, and continues to pursue similar relationships
with other companies in biomaterials.
Cautionary Note Regarding Forward-Looking Statements
This press release may contain forward-looking statements regarding Orthovita's
current expectations of future events that involve risks and uncertainties as listed
from time to time in reports we file with the U.S. Securities and Exchange Commission
(SEC), including but not limited to risks described in our most recently filed Form
10-K and Form 10-Q under the caption "Certain Risks Related to Our Business".
Further information about these and other relevant risks and uncertainties may be
found in Orthovita's filings with the SEC, all of which are available from the SEC
as well as from Orthovita upon request. Orthovita undertakes no obligation to publicly
update any forward-looking statements.
CONTACT: Orthovita, Inc.
Joseph M. Paiva, 610-640-1775 or 800-676-8482
SOURCE: Orthovita, Inc.
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6/8/2006
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Orthovita to Present at Needham & Company, LLC, Fifth Annual Biotechnology and
Medical Technology Conference
MALVERN, Pa.--(BUSINESS WIRE)--June 8, 2006--Orthovita, Inc. (NASDAQ NM: VITA),
a leading developer of orthopedic biomaterials, announced today that it will participate
as a presenting company at the Needham & Company, LLC, Fifth Annual Biotechnology
and Medical Technology Conference. Antony Koblish, chief executive officer of Orthovita,
is scheduled to present on Wednesday, June 14th, at 2:30 p.m. Eastern Time, at the
New York Palace Hotel, 455 Madison Avenue, New York, NY. A live webcast of this
presentation will be available at
http://www.wsw.com/webcast/needham15/vita/ and will be archived at the same
URL for on-demand listening for 30 days following the conference.
About the Company
Orthovita is a biomaterials company with proprietary technologies for the development
and commercialization of synthetic, biologically active, tissue engineering products
for orthopedic and neurosurgical applications. Our products are used in the regeneration
of bone and soft tissue healing. Our near-term commercial business is based on our
internally developed VITOSS(R) Bone Graft Substitute technology platforms, which
are designed to address the non-structural bone graft market by offering synthetic
alternatives to the use of autograft or cadaver-derived bone material to meet a
broad range of orthopedic clinical needs in the spine, trauma, joint reconstruction,
revision surgery and extremities markets, and VITAGEL(TM) Surgical Hemostat, which
is an adherent matrix and an impermeable barrier to blood flow. Our longer-term
U.S. clinical development program is focused on our internally developed CORTOSS(R)
Synthetic Cortical Bone technology platform, which is designed for injections in
osteoporotic spines to treat vertebral compression fractures. Orthovita works jointly
with Kensey Nash Corporation and Angiotech Pharmaceuticals, Inc., to develop and
market synthetic-based biomaterial products, and continues to pursue similar relationships
with other companies in biomaterials.
Cautionary Note Regarding Forward-Looking Statements
This press release may contain forward-looking statements regarding Orthovita's
current expectations of future events that involve risks and uncertainties as listed
from time to time in reports we file with the U.S. Securities and Exchange Commission
(SEC), including but not limited to risks described in our most recently filed Form
10-K and Form 10-Q under the caption "Certain Risks Related to Our Business".
Further information about these and other relevant risks and uncertainties may be
found in Orthovita's filings with the SEC, all of which are available from the SEC
as well as from Orthovita upon request. Orthovita undertakes no obligation to publicly
update any forward-looking statements.
CONTACT: Orthovita, Inc.
Joseph M. Paiva, 610-640-1775 or 800-676-8482
SOURCE: Orthovita, Inc.
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6/22/2006
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Orthovita to Present at Jefferies Life Sciences Conference
MALVERN, Pa.--(BUSINESS WIRE)--June 22, 2006--Orthovita, Inc. (NASDAQ NM:VITA),
a leading developer of orthopedic biomaterials, announced today that it will participate
as a presenting company at the Jefferies Life Sciences Conference. Joseph Paiva,
chief financial officer of Orthovita, is scheduled to present on Wednesday, June
28th, at 8:30 a.m. Eastern Time, at the Mandarin Oriental Hotel, 80 Columbus Circle
at 60th Street, New York, NY. A live, audio-only webcast of this presentation will
be available at http://www.wsw.com/webcast/jeff11/vita/
and will be archived at the same URL for 90 days following the conference.
About the Company
Orthovita is a biomaterials company with proprietary technologies for the development
and commercialization of synthetic, biologically active, tissue engineering products
for orthopedic and neurosurgical applications. Our products are used in the regeneration
of bone and soft tissue healing. Our near-term commercial business is based on our
internally developed VITOSS(R) Bone Graft Substitute technology platforms, which
are designed to address the non-structural bone graft market by offering synthetic
alternatives to the use of autograft or cadaver-derived bone material to meet a
broad range of orthopedic clinical needs in the spine, trauma, joint reconstruction,
revision surgery and extremities markets, and VITAGEL(TM) Surgical Hemostat, which
is an adherent matrix and an impermeable barrier to blood flow. Our longer-term
U.S. clinical development program is focused on our internally developed CORTOSS(R)
Synthetic Cortical Bone technology platform, which is designed for injections in
osteoporotic spines to treat vertebral compression fractures. Orthovita works jointly
with Kensey Nash Corporation and Angiotech Pharmaceuticals, Inc., to develop and
market synthetic-based biomaterial products, and continues to pursue similar relationships
with other companies in biomaterials.
Cautionary Note Regarding Forward-Looking Statements
This press release may contain forward-looking statements regarding Orthovita's
current expectations of future events that involve risks and uncertainties as listed
from time to time in reports we file with the U.S. Securities and Exchange Commission
(SEC), including but not limited to risks described in our most recently filed Form
10-K and Form 10-Q under the caption "Certain Risks Related to Our Business".
Further information about these and other relevant risks and uncertainties may be
found in Orthovita's filings with the SEC, all of which are available from the SEC
as well as from Orthovita upon request. Orthovita undertakes no obligation to publicly
update any forward-looking statements.
CONTACT: Orthovita, Inc.
Joseph M. Paiva, 610-640-1775 or 800-676-8482
SOURCE: Orthovita, Inc.
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