Cartiva Announces FDA Premarket Approval For Cartiva Synthetic Cartilage Implant

First PMA Approved Alternative to Fusion for Arthritis of the Big Toe Joint

ALPHARETTA, Ga.--(BUSINESS WIRE)--Cartiva, Inc., a developer of innovative products for the treatment of cartilage damage and osteoarthritis, announced today that it received Premarket Approval (PMA) from the U.S. Food and Drug Administration (FDA) for its Cartiva Synthetic Cartilage Implant (SCI) for arthritis of the big toe joint. The approval allows the Company to begin marketing in the United States the first synthetic cartilage device approved by the FDA.

“We are thrilled with the approval of Cartiva SCI and appreciate the hard work and collaboration of the U.S. Food and Drug Administration orthopaedic branch. We’re grateful to our clinical investigators, their study coordinators and, of course, our patients in helping us reach this critical milestone”

Cartiva SCI is intended for the treatment of painful arthritis at the base of the big toe, the most common arthritic condition in the foot. The current standard of care involves fusing the bones in the arthritic joint with screws and plates. While fusion is an effective procedure for eliminating pain, it permanently prevents movement of the joint.

The Cartiva SCI device, an alternative to fusion, is a biocompatible, biomedical polymer implant designed to have physical properties similar to those of articular cartilage. Damaged cartilage is replaced with a small Cartiva SCI implant that provides a cartilage-like compressible, low-friction and durable bearing surface. The implant provides pain relief and improves both function and motion.

The FDA’s decision was supported by the MOTION clinical study, a 236-patient, multi-center, prospective, randomized study comparing Cartiva SCI to fusion – the largest study ever conducted for this condition.

Key findings from the Level I clinical study include:

• The Cartiva patient group demonstrated clinical success of 80% for the composite primary endpoint (pain, function and safety) at 24 months compared to 79% success for the fusion group
• Cartiva patients achieved a 93% reduction in median pain
• Cartiva patients demonstrated a 168% improvement in median function of sporting activities and 65% improvement in activities of daily living
• Cartiva patients experienced a 26% improvement in range of motion from baseline

“The landmark MOTION study clearly shows Cartiva SCI to be a safe and effective alternative to fusion for patients wishing to maintain motion in their great toe,” said Dr. Judith Baumhauer, Professor and Associate Chair of Academic Affairs, University of Rochester Medical Center, and Principal Investigator on the MOTION study. “Based on these compelling results, I have eagerly awaited the FDA approval and the ability to offer this treatment option to my patients.”

Cartiva SCI has been approved for use outside the United States since 2002 and is currently available in Europe, Canada and Brazil. To date, more than 4,000 implants have been used. It is performed in a simple outpatient procedure lasting approximately 35 minutes. Unlike a fusion procedure, patients may begin weight bearing immediately as tolerated.

“Before Cartiva SCI, the options we could provide to patients with osteoarthritis of the great toe were limited, as the fusion procedure often necessitates sacrificing range of motion to get pain relief,” said Dr. Mark Glazebrook of the Queen Elizabeth II Health Sciences Centre in Halifax, Nova Scotia, who uses Cartiva SCI in his practice. “Due to the simplicity of the procedure, speed of recovery and range of motion benefits, I see that patients are relieved to have this option available to them and the majority are electing Cartiva over fusion.”

“We are thrilled with the approval of Cartiva SCI and appreciate the hard work and collaboration of the U.S. Food and Drug Administration orthopaedic branch. We’re grateful to our clinical investigators, their study coordinators and, of course, our patients in helping us reach this critical milestone,” said Tim Patrick, president and CEO, Cartiva, Inc. “We look forward to introducing Cartiva SCI at the American Orthopaedic Foot and Ankle Society Annual Meeting in Toronto later this month.”

About Cartiva, Inc.

Based in Alpharetta, Ga., Cartiva, Inc. develops and markets innovative solutions for patients with cartilage damage and osteoarthritis. Cartiva’s venture investors include New Enterprise Associates, Windham Venture Partners and Domain Associates. Additional information is available on the company’s website at www.cartiva.net.