Orthovita Issued Patent For Filled Canister That Prepares and Delivers Synthetic Biomaterial in Surgical Procedures To Repair Human Bone.

Business Editors/Health/Medical Writers

BIOWIRE2K

MALVERN, Pa.--(BUSINESS WIRE)--June 2, 2004

U.S. Patent No. 6,736,799 Claims Include Apparatus for Preparing a

Biological Composite That Provides New Options and Flexibility for

Orthopaedic Surgeons

Orthovita, Inc. (NASDAQ NM / NASDAQ Europe: VITA), a leading developer of orthopaedic biomaterials, announced today that it has been granted a U.S. patent covering the company's Filled Canister apparatus used in preparing a biological composite for use in a range of bone repair procedures. Orthovita's VITOSS(R) Filled Canister offers surgeons a more efficient way to administer synthetic biomaterial products including VITOSS Scaffold Synthetic Cancellous Bone Void Filler.

The patent covers Orthovita's Filled Canister apparatus for preparing a biological composite, as well as a kit for the preparation and delivery of biologically active composites. In addition to simplifying the preparation of materials for surgery, the Filled Canister improves the delivery process for synthetic biomaterials used in bone repair.

"This patent provides Orthovita with broad claims to protect our rapidly expanding technology base using our VITOSS biomaterial platform," said Erik Erbe, Ph.D., chief science officer at Orthovita. "The Filled Canister takes advantage of the benefits of VITOSS and other porous calcium phosphate materials to create composites that represent the optimal combination of biological fluids and cells to drive bone growth."

VITOSS is a synthetic biomaterial that helps promote the body's natural process for bone healing and regrowth. Use of synthetic biomaterials in bone repair may help patients to avoid treatment options including painful bone grafts or the use of bone harvested from cadavers. This new patent for delivery and preparation of VITOSS supports the ongoing functionality of Orthovita's strong product line of synthetic biomaterial for bone repair.

VITOSS Scaffold Synthetic Cancellous Bone Void Filler is made using nanometer-sized particles, creating a highly porous (90% interconnected porosity) structure that is able to soak and hold up to 300% of its own weight in autogenous blood or bone marrow that, in turn, promotes bone growth. The composition of VITOSS enriched with marrow cells is used to repair bone defects in the spine, extremities and pelvis caused by trauma and surgery. The absorbed bone marrow is a proven source of bone healing cells and signaling factors.

The Filled Canister includes a material chamber that houses calcium phosphate materials having macro-, meso- and micro-porosity. The apparatus also includes a dismountable end cap provided with a point of attachment for an aspiration needle. The kit includes an instrument for the injection and withdrawal of one or more biological fluids and a porous, biocompatible material, representing a convenient option to help surgeons use biomaterials in bone repair procedures.

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 several 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 are marketing IMBIBE(R) Bone Marrow Aspirate Syringe to be used with VITOSS, ALIQUOT(TM) Microdelivery System to be used with CORTOSS, and ENDOSKELETON(TM) to be used in the thoracolumbar spine to replace all or part of a collapsed, damaged or unstable vertebral body due to trauma or tumor.

Orthovita also pursues opportunities to work jointly with other leaders in biomaterials research and product development. Orthovita 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 options 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, 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. for use in vertebral augmentation procedures. 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 in Europe 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 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, the rate at which we invest in our field sales network, the ability of our field sales network to generate new sales, our ability to enter into an agreement to commercialize and distribute VITOSS in Japan, 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.