First patient treated in Carticept Medical's Cartiva SCI study

Carticept Medical, Inc., a developer of innovative products for the treatment of cartilage injuries and osteoarthritis, today announced that the first patient has been treated in an international, multi-center study of the Company's Cartiva Synthetic Cartilage Implant (SCI). The study aims to determine the effectiveness of Cartiva SCI in comparison to arthrodesis (joint fusion), the current standard of care, for reducing the debilitating pain associated with osteoarthritis of the first metatarsophalangeal (MTP) joint.

Cartiva SCI is a proprietary polyvinyl alcohol (PVA) cryogel device designed to mimic natural cartilage. The device is intended to maintain natural joint mechanics by repairing focal cartilage defects while minimizing the resection of healthy tissue. Due to its similar properties to native cartilage, joint resurfacing with Cartiva SCI does not require replacement of the opposing surface. It is expected that patients may be able to return to normal activities more quickly than when treated with joint fusion.

"Initiating patient enrollment is an important milestone for Carticept as we progress toward our goal of making this therapy commercially available to our first target patient population in the United States--those suffering from the pain and limited function associated with metatarsophalangeal osteoarthritis," said Timothy J. Patrick, President and Chief Executive Officer. "Several thousand patients have been treated with Cartiva SCI outside the United States and we believe it is ideal not only for the toe, but also for other joints in the foot, as well as the knee and hand."

Cartiva SCI is currently available in Canada, Europe and South America where it is primarily used for resurfacing of the MTP joint, the carpometacarpal joint and the knee.

More than two million people in the United States suffer from osteoarthritis of the MTP joint. The pain associated with this condition frequently leads patients to make adjustments to movement that can have an adverse impact on other joints or even to a more sedentary lifestyle, which can place sufferers at elevated risk for unhealthy weight gain and cardiovascular disease.

"Cartiva SCI may not only reduce pain, but also maintain mobility of the joint. This will certainly improve the quality of life for patients with great toe arthritis," said Judith F. Baumhauer, MD, Associate Chair of Academic Affairs and Professor, Division of Foot and Ankle Surgery, Department of Orthopaedics at the University of Rochester and principal investigator of the Cartiva SCI trial. “These patients seek care because they are a young, active group.”

The first patient in the pivotal trial was treated at St. Michael’s Hospital in Toronto, ON. The lead investigator at this site, Dr. Timothy Daniels, MD, Associate Professor at the University of Toronto, said, “Osteoarthritis of the MTP joint is a significant problem for millions of patients worldwide and many desire pain relief with preservation of motion, so we are excited to be able to initiate such an important study.”

Carticept expects to enroll 249 patients at 13 sites throughout Canada, the United Kingdom and the United States.