Orthovita receives 510(k) clearance to market Vitoss BA Bimodal Bone Graft Substitute

Feb 10 2011

Orthovita, Inc. (NASDAQ: VITA), an orthobiologics and biosurgery company, announced today that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market Vitoss™ BA Bimodal Bone Graft Substitute as a non-structural bone void filler for use in the extremities, pelvis and posterolateral spine. Vitoss™ Bimodal is anticipated to launch in the United States in 9-12 months after the introduction of Vitoss™ BA2X which will be commercially introduced by Orthovita next week at the 2011 Meeting of the American Academy of Orthopedic Surgeons.

“Our goal is to develop best in class orthobiologic products that meet these needs. By introducing a broader array of product offerings, we better serve the needs of patients, surgeons and hospitals.”

Vitoss BA Bimodal differs from previous versions of Vitoss BA by modifying the size distribution of the bioactive glass particles to accelerate resorption of the bioactive glass. Orthopedic and spine surgeons believe accelerated resorption is an important characteristic in grafting material.

"Surgeons need an array of spine and orthopedic bone grafting products with properties designed to fit the unique patient challenges that present each day," said Antony Koblish, President and Chief Executive Officer of Orthovita. "Our goal is to develop best in class orthobiologic products that meet these needs. By introducing a broader array of product offerings, we better serve the needs of patients, surgeons and hospitals."

In addition, said Koblish, "We are pleased by our success in effectively working with FDA to continue to gain product clearances and execute against our strategy of progressing sequential versions of Vitoss including new bioactive technologies."

Vitoss™ BA Bimodal contains Orthovita's proprietary Vitoss beta-tricalcium phosphate bone graft substitute scaffold and Kensey Nash Corporation's proprietary collagen material. In the event Orthovita launches Vitoss BA Bimodal, Orthovita would be obligated to pay Kensey Nash to manufacture the product as well as make certain royalty payments to Kensey Nash based on the net sales of such product in accordance with Orthovita's development, manufacturing and supply agreement with Kensey Nash Corporation.