Orthovita Granted FDA IDE Approval To Begin U.S. CORTOSS--R-- Pilot Study In Vertebral Compression Fracture Repair Using the Kyphoplasty Technique.

Business Editors/Health/Medical Writers

MALVERN, Pa.--(BUSINESS WIRE)--May 1, 2003

Orthovita, Inc. (NASDAQ NM / NASDAQ Europe:VITA), a leading developer of orthopaedic biomaterials, reported today it has received Investigational Device Exemption approval from the U.S. Food and Drug Administration allowing the company to begin a second pilot human clinical study to evaluate the use of CORTOSS(R) Synthetic Cortical Bone Void Filler in the treatment of vertebral compression fractures ("VCF") utilizing the kyphoplasty treatment technique.

In the kyphoplasty treatment technique employed in this study, an inflatable bone tamp is used to attempt to reduce the fracture and create a void in which the biomaterial can be injected. Orthovita's synthetic biomaterial, CORTOSS, will be injected percutaneously through the skin into the fractured vertebra to stabilize and restore load-bearing capability.

Orthovita's new U.S. study will assess the ability of CORTOSS to provide both pain relief and improvement in function to the patient by providing stability to the fractured vertebra. The new pilot study will be conducted at four sites and will enroll a total of 20 patients.

In January 2003, Orthovita initiated patient enrollment in its first pilot clinical study in the U.S. to evaluate the use of CORTOSS in the treatment of VCF utilizing the vertebroplasty treatment technique. Also in January 2003, Orthovita received approval to market CORTOSS in Europe for vertebral augmentation, including the repair of VCF caused by osteoporosis and invasive tumors.

In Europe, CORTOSS has been used successfully in the treatment of VCF utilizing both the vertebroplasty and kyphoplasty treatment techniques.

"We believe that CORTOSS is the ideal biomaterial for all vertebral compression fracture treatment techniques," said Antony Koblish, president and chief executive officer of Orthovita. "CORTOSS offers several important advantages over the use of PMMA bone cement and calcium phosphate materials for the treatment of vertebral compression fractures. Our CORTOSS VCF strategy is to systematically complete both of our vertebroplasty and kyphoplasty pilot studies, to be followed by a pivotal study that we will design to include both treatment techniques. We also look forward to announcing the completion of patient enrollment for our vertebroplasty pilot study shortly."

CORTOSS is a high-strength, bone-bonding, biocompatible, non-monomer eluting, self-setting composite engineered to mimic the characteristics of human cortical bone. Administered directly to the affected area using a pre-filled, unit dose disposable cartridge, CORTOSS has the capacity to provide immediate weight-bearing support.

In surgery, CORTOSS's inherent radiopacity makes it very easy to see using standard imaging techniques.

Unlike polymethylmethacrylate (PMMA), the orthopedic bone cement that is often used "off-label" in vertebral augmentation procedures, CORTOSS has been engineered for the treatment of vertebral compression fractures. CORTOSS does not contain volatile monomers, which are found in PMMA and can migrate uncontrolled in the body.

The CORTOSS mix-on-demand delivery system also does not require premixing, allowing the physician greater control over when the material can be applied during the procedure, even when spread over multiple time points. Because it is inherently radiopaque, CORTOSS allows for excellent visualization of its placement under fluoroscopy or in post-operative imaging studies.

The polymerization or setting of the material has a much lower temperature when compared to PMMA, and is being investigated for its ability to reduce the risk of thermal tissue damage. Animal studies demonstrated that the CORTOSS-to-bone interface continues to be strengthened over time, with more bone being formed and integrated onto and into the material.

Unlike calcium phosphate biomaterials, CORTOSS has been engineered with the appropriate strength and elasticity to be used in full load-bearing, stand alone applications such as is found in osteoporotic VCF patients.

According to the U.S. National Osteoporosis Foundation, 700,000 vertebral fractures occur annually. The most common causes of vertebral compression fractures are osteoporosis associated with aging or chronic steroid use and metastatic disease. Each year, over 270,000 vertebral compression fractures are clinically diagnosed in the U.S. alone, with the number expected to rise in the years ahead. Patients are typically treated with external bracing, analgesics and bed rest.

In a significant proportion of cases, patients are left with persistent pain and limited mobility. Bed rest and reduced mobility both have significant effects on a patient's quality of life, as well as on subsequent morbidity and mortality. For example, standard medical therapy for vertebral compression fractures may lead to additional bone mineral loss, thus increasing the risk of subsequent fractures.

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(R) Synthetic Cancellous Bone Void Filler, CORTOSS(R) 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.

In addition, we have developed IMBIBE(TM) Bone Marrow Aspirate Syringe used with VITOSS and ALIQUOT(TM) Microdelivery System used with CORTOSS.

Orthovita also pursues opportunities to work jointly with other leaders in biomaterial research and product development. The company recently established a collaboration with Kensey Nash Corporation (Nasdaq:KNSY) to commercialize new products based on Orthovita's proprietary, ultra porous VITOSS bone void filler material in combination with proprietary Kensey Nash biomaterials.

The new products to be developed under this collaboration are expected to broaden the spectrum of surgical operations available to our surgeon customers and enhance the deliverability of our VITOSS product line.

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 for use in screw augmentation and vertebral augmentation procedures including compression fractures caused by osteoporosis and invasive tumors.

CORTOSS is not available for commercial distribution in the U.S. We are conducting clinical studies of CORTOSS required for approval in the U.S. In addition, we completed post-marketing human clinical studies of CORTOSS in Europe for its use in hip compression screw augmentation.

RHAKOSS is under development as a preformed 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.

We are conducting clinical studies of RHAKOSS in Europe required to obtain a CE Mark for its use as an interbody fusion device.

This press release contains forward-looking statements regarding our current expectations of future events that involve risks and uncertainties, including, without limitation, 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 Orthovita'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.

Source: Orthovita, Inc.