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Orthovita Continues the U.S. Introduction of VITOSS Synthetic Cancellous Bone Void Filler; Presents Data at the American Association of Neurological Surgeons Annual Meeting.

Business Editors/Health & Medical Writers

MALVERN, Pa. & TORONTO--(BW HealthWire)--April 23, 2001

Orthovita, Inc. (Nasdaq: VITA / Nasdaq Europe: VITA) today outlined the applications of its new synthetic cancellous bone void filler, VITOSS(TM), for use in surgical bone repair procedures in the spine, extremities and pelvis.

The update was provided at the annual meeting of the American Academy of Neurological Surgeons (AANS) in Toronto, Canada, and follows the February 2001 launch of VITOSS in the United States.

At the AANS meeting, Orthovita presented pre-clinical data showing that VITOSS rapidly healed 10mm X 25mm sized bone defects. Bone healing throughout the defect site was concurrent with evidence of cell-mediated resorption of VITOSS at all time points. The newly formed bone underwent maturation and remodeling in response to physiologic loads.

Histologically and radiographically, the newly formed bone within the defect sites was virtually indistinguishable from the surrounding undisturbed bone at 12-, 24- and 52-week follow up. Approximately 76% of VITOSS morsels were resorbed at six weeks and 86% were resorbed at 12 weeks.

"The VITOSS data presented at today's meeting look promising," said Edward Benzel, M.D. Director of Spinal Disorders at the Cleveland Clinic. "Evidence of rapid healing in the model presented appears to be driven by the highly porous structure of VITOSS and by its ability to readily absorb and transport nutrients and bone forming cells into the defect while healing proceeds."

VITOSS received U.S. Food and Drug Administration (FDA) marketing clearance in late December, 2000, for the repair of bone defects created surgically or through injury or trauma. The product was also successfully launched in Europe in October 2000.

At 52 weeks in the pre-clinical study, virtually all of the VITOSS implant had been resorbed through cell driven processes and was replaced by healthy viable bone.

"VITOSS synthetic cancellous bone void filler is the first 90% porous Beta-Tricalcium Phosphate scaffold designed to soak and hold 300% of its own weight in blood and bone marrow," said Maarten Persenaire, M.D., vice president of medical affairs at Orthovita. "This ability to soak and retain a large volume of cells and nutrients in the defect site helps to drive a rapid bone healing process."

In another pre-clinical study, the Urist Osteoinduction test, VITOSS and bone marrow aspirate (BMA) showed the ability to form bone in a subcutaneous pouch, where no bone had previously existed, without contact with native bone.

These data demonstrate that VITOSS, when mixed with bone marrow aspirate (BMA), exhibited a faster rate of bone formation, with more consistent bone formation throughout the graft material at two, four and eight weeks when compared to the leading demineralized bone matrix (DBM) human cadaver allograft.

VITOSS mixed with BMA yielded significantly better bone architecture and maturity at each time point when compared to the leading DBM.

VITOSS is the first engineered 90% porous beta-tricalcium phosphate synthetic cancellous bone void filler designed to resemble natural human cancellous bone in both chemistry and structure.

The product is formed using Orthovita's patented solution-based chemistry process that assembles nanometer-sized calcium phosphate particles into an interconnecting lattice structure and is available in a scaffold matrix in both morsel and block forms.

Injury or trauma to the bone, as well as degenerative conditions, disease and aging, affect the health and viability of the human skeleton. These conditions often result in the need for the repair of bone defects through a bone grafting procedure.

Approximately 500,000 bone-grafting procedures occur each year in the spine, extremities and pelvis, representing a market potential of $300 million. Currently, grafts use bone taken from the patient (autograft) and re-implanted in the damaged area, or grafts using bone material harvested from cadaver bone (allograft).

VITOSS eliminates the additional, painful surgical procedure required in bone grafting, as well as the use of bone repair materials developed from cadaver bone.

About the Company

Orthovita is a biomaterials company with proprietary techniques for the development of novel products for use in orthopedics. Our focus is on developing novel products for use in spine surgery and in the repair of osteoporotic fractures. We are also addressing a broad range of clinical needs in the trauma market.

Our dedicated focus has resulted in the development of three products, VITOSS Synthetic Cancellous Bone Void Filler, CORTOSS(TM) Cortical Bone Void Filler and RHAKOSS(TM) Synthetic Bone Implants, that we believe offer a wide range of clinical applications at various anatomical sites.

VITOSS is a resorbable calcium phosphate scaffold that, like human cancellous bone, is highly porous and composed of extremely fine calcium phosphate mineral that allows for resorption, cell seeding and ingrowth of host bone. VITOSS was cleared for sale in the U.S. and Australia, and approved for sale under a CE Mark in Europe.

CORTOSS is under development as a high-strength, bone-bonding, self-setting composite engineered specifically to mimic the strength characteristics of human cortical bone. We are pursuing clinical studies for multiple indications of CORTOSS, including the augmentation of screws and vertebral fractures. CORTOSS was cleared for sale in Australia.

RHAKOSS is under development as preformed, injection-molded composites that mimic the natural dual cortical-cancellous composition of human bone, providing high-strength while also allowing for resorption, cell seeding and the ingrowth of host bone to address the vertebral interbody fusion and spinal reconstruction market.

This press release contains forward-looking statements by the Company regarding our expectations as to our CORTOSS, VITOSS and RHAKOSS products, and other aspects of our business, which involve risks and uncertainties and may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.

Such statements are based on our current expectations and are subject to a number of risks and uncertainties that could cause results to differ materially from those addressed in the forward-looking statements.

Factors that may cause such a difference include, but are not limited to, our history of operating losses and our need for additional funds, as well as uncertainties in preclinical and clinical trial results, in gaining regulatory approvals, in scaling-up manufacturing, in market acceptance and in the sales levels of our products.

Further information about these and other relevant risks and uncertainties may be found in the Company's filings with the Securities and Exchange Commission, all of which are available from the Commission as well as other sources.
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Publication:Business Wire
Date:Apr 23, 2001
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