Studies Confirm Orthovita's VITOSS Synthetic Bone Scaffold Effective in Trauma and Spine Surgery


MALVERN, Pa.--(BW HealthWire)--May 10, 2002--

Five Independent Studies Published in Special Supplement to Peer-Reviewed Journal Orthopedics Indicate VITOSS(TM) Synthetic Bone Scaffold's Potential to Improve Patient Outcomes in Trauma and Spinal

Surgery While Eliminating or Reducing Risks and Disadvantages

Associated With Use of Autograft or Allograft

The First Engineered 90% Porous Beta-Tricalcium Phosphate-Based Bone Scaffold Allows for Essential Migration of Nutrients, Growth Factors

and Osteogenic Cells Necessary for Bone Growth and Repair

Orthovita, Inc. (NASDAQ:VITA / EASDAQ:VITA), a biomaterials company that develops synthetic tissue engineering products for restoration of the human skeleton, today announced new clinical data showing that the company's ultraporous beta-tricalcium phosphate (VITOSS(TM) Scaffold) synthetic cancellous bone void filler product is effective in trauma and spinal surgery and has the potential to improve patient outcomes when used alone or in conjunction with autograft or structural allograft tissue.

The clinical data were reported in a special supplement to the May 2002 issue of the peer-reviewed journal Orthopedics published today.

VITOSS is a highly porous scaffold composed of nanometer-sized calcium phosphate particles with 90% interconnecting porosity that replicates the characteristics of human cancellous bone.

According to preliminary results from three separate ongoing studies in the U.S. and Europe, a total of ninety-five patients who underwent spinal fusion procedures (a "welding" process where two or more vertebrae are joined together) all received VITOSS synthetic bone as an adjunct or "extender" to autograft or allograft bone.

At 3-6 month follow-up, all 61 patients who received VITOSS as an autograft extender and all 34 patients who received VITOSS/venous blood mixture as an allograft extender were judged to progress successfully to a solid fusion.

Some patients treated with a combination of VITOSS and autograft appeared to have a somewhat faster consolidation and progression to fusion when compared to patients treated with autologous bone graft alone.

One of the disadvantages for patients undergoing spinal fusion procedures is the need to harvest bone from other areas in the body or use bone collected from cadavers. These results show that VITOSS offers important clinical advantages and helps to reduce the risks associated with spinal fusion for patients who are treated with either of these options.

Further studies are planned to confirm and expand these results.

In one study, VITOSS eliminated the need for harvested autograft in seven (14%) of 50 patients, indicating that VITOSS could be a viable option for patients with no residual graft in the iliac area (hip bone), or with a decreased quality of graft due to osteoporosis.

"While autograft remains the gold standard for lumbar spinal fusions, these studies indicate that VITOSS can offer significant advantages as an extender to autograft or allograft, and in some cases can even be used alone successfully," said Raymond Linovitz, MD, FACS, spine surgeon from San Diego, CA, and a lead researcher on one of the studies.

According to the American Academy of Orthopedic Surgeons, nearly 260,000 spinal fusions are performed each year in the U.S. For many different types of bone injury or damage, bone grafts act as a scaffold to facilitate new bone growth and healing.

The most common form of repair used in spinal fusion or for damaged cancellous bone is the autograft, where the patient's own bone material is harvested from elsewhere in the body (usually the hip bone) and then re-implanted into the affected area. Autograft requires the patient to undergo a second, potentially painful, surgical procedure to retrieve the additional bone material.

Allograft is an option where surgeons implant bone tissue made from cadavers. In addition to concerns about supply and product safety and purity, cadaver bone may be rejected by patients following implantation.

The use of VITOSS can help to reduce some of the disadvantages associated with the use of autograft or allograft, including donor site pain, increased operative time and morbidity linked to autograft harvest, and the possibility of disease transmission and immunologic reactions associated with the use of allograft.

VITOSS was approved in Europe in October 2000. In December 2000, Orthovita was granted 510(k) marketing clearance for VITOSS by the U.S. Food and Drug Administration (FDA) for use in orthopedic surgeries for the repair of bone defects in the spine, extremities and pelvis.

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 Cancellous Bone Void Filler, CORTOSS(TM) Synthetic Cortical Bone Void Filler and RHAKOSS(TM) Synthetic Bone Spinal Implant, 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 is 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. CORTOSS is cleared for sale in Australia and is approved for sale under a CE Mark in Europe. We are also conducting clinical studies with CORTOSS required for its approval in the U.S.

RHAKOSS is under development as a preformed, injection-molded composite that closely mimics the mechanical characteristics 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 regarding our current expectations of future events that involve risks and uncertainties, including without limitations, 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 dependence on the commercial success of our approved products, our history of operating losses and our need for additional funds, our need to obtain and maintain regulatory approvals to sell our products, our ability to manage commercial scale manufacturing capability and capacity, risks and uncertainties in pre-clinical and clinical trial results, market acceptance of our products, 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.

CONTACT:

Orthovita, Inc.

by

Berry & Company

Jim Wetmore, 212/279-2060

jwetmore@berrypr.com

SOURCE: Orthovita, Inc.