CORTOSS Receives European Regulatory Approval; Second Orthovita Biostructures Product Approved to Market.

Business Editors & Health/Medical Writers

BIOWIRE2K

MALVERN, Pa. & LEUVEN, BELGIUM--(BW HealthWire)--Oct. 30, 2001

CORTOSS is a new high strength, bone bonding synthetic structural

graft material engineered to mimic the characteristics of human

cortical bone and to aid in the treatment of patients with

osteoporotic fractures.

Orthovita, Inc. (NASDAQ-NM / NASDAQ-Europe: VITA), a leading developer of orthopaedic biomaterials, announced today that it has received approval to market CORTOSS Synthetic Cortical Bone Void Filler in Europe for the fixation of bone screws used in patients with weak bone caused by osteoporosis.

The company expects to make CORTOSS available to surgeons beginning in December 2001.

There are 2.3 million osteoporotic fractures in Europe and the United States each year. One in three women over the age of 50 is affected by osteoporosis and one in eight men over the age of 50 is considered at risk for the disease.

The International Osteoporosis Foundation estimates that every 30 seconds someone in the European Union fractures a bone as a result of osteoporosis. Osteoporotic fractures most commonly occur in the hip, long bones and spine. The market potential for anchoring bone screws used to repair these fractures is currently estimated to be $200,000,000.

"One of the great challenges in treating fractures of the hip, spine and long bones in patients with severe osteoporosis is helping them to quickly get back on their feet and return to normal activity. Osteoporotic fracture patients that remain bedridden for an extended length of time often develop secondary complications due to inactivity. Because CORTOSS mimics the strength and flexibility of cortical bone, we now have an effective synthetic structural graft to provide needed fixation for bone screws that otherwise would not hold," said Marek Szpalski, MD, a senior consultant at Centre Hospitalier Moliere Longchamps, in Brussels, Belgium. "CORTOSS allows bone screws to immediately hold in osteoporotic bone, helping to provide much needed fracture stability that can assist in getting osteoporotic patients up and moving."

"The approval of CORTOSS in Europe represents an important milestone for Orthovita," said Bruce Peacock, president and CEO of Orthovita. "CORTOSS and Orthovita's first approved product, VITOSS scaffold, are both synthetic biostructures designed for the in-vivo restoration of the human skeleton."

"Both products are designed to meet the clinical needs of specific types of patients," explained Mr. Peacock. "VITOSS is designed to help patients with good bone quality to heal rapidly. CORTOSS provides immediate structural stability for osteoporotic patients with diminished capacity to regenerate new bone while offering significant advantages for surgeons who treat patients with fractures due to osteoporosis."

CORTOSS has been used successfully in recent trials to treat a variety of osteoporotic fracture patients. The results of a recent clinical study of 35 osteoporotic patients in Norway were presented at the British Orthopaedic Association in September, 2001. The patients, all of whom had experienced ankle fractures, were treated with more than 80 screws reinforced using CORTOSS.

Ninety nine percent of those screws remained immobilized and well fixed at one year follow up. All patients in the clinical study went on to heal successfully.

"Following the launch of VITOSS, in October, 2000, Orthovita is now solidly positioned as the international leader in the development and marketing of synthetic biostructures to treat a broad range of bone defects," said Antony Koblish, senior vice president of marketing at Orthovita. "We are the first company to offer synthetic bone alternatives for use in repairing both damaged cancellous and damaged cortical bone."

CORTOSS is a proprietary biocompatible, resin-polymer composite that is aseptically packaged and easily injected into weakened, osteoporotic bone. The delivery system offers surgeons "mix-on-demand" flexibility and allows for accurate dosing and placement into the surgical site. Orthovita has filed an IDE application with the Food and Drug Administration (FDA) seeking to initiate CORTOSS clinical studies in the United States.

About the Company

Orthovita is a biomaterials company with proprietary technologies applied to the development of biostructures, synthetic biologically active tissue engineering products for restoration of the human skeleton. 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.

We have applied our technologies to the development of three products, VITOSS(TM) Synthetic Bone Scaffold, CORTOSS(TM) Synthetic Cortical Structural Graft and RHAKOSS(TM) Synthetic Bone Spinal Implants, that we believe offer a wide range of clinical applications at various anatomical sites.

VITOSS is a resorbable calcium phosphate scaffold that 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 a high-strength, bone-bonding, self-setting composite engineered specifically to mimic the strength characteristics of human cortical bone. In the U.S. we are pursuing clinical studies for multiple indications of CORTOSS, including the augmentation of screws and vertebral fractures. CORTOSS is cleared for sale in Australia and is approved for sale in Europe.

RHAKOSS is under development as a preformed, injection-molded composite that mimics the natural dual cortical-cancellous composition of human bone, providing high-strength while also allowing for 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 VITOSS, CORTOSS and RHAKOSS products and other aspects of our business.

Such statements are based on our 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 include, but are not limited to, our history of operating losses and our need for additional funds, as well as the risks and uncertainties in preclinical and clinical trial results, gaining regulatory approvals, scaling-up manufacturing, market acceptance, the sales levels of our products, research and development, competition and other risk factors listed from time to time in reports filed by the Company with the Securities and Exchange Commission, 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 the Company's filings with the Commission, all of which are available from the Commission as well as other sources. Orthovita undertakes no obligation to publicly update any forward-looking statements.