Cartiva Announces Completion of Multicenter Trial of Synthetic Cartilage Implant for Osteoarthritis in the Great Toe

ALPHARETTA, Ga.–(BUSINESS WIRE)–Cartiva, Inc., a developer of innovative solutions for the treatment of cartilage damage and osteoarthritis, announced today that all scheduled two-year follow up patient visits have been completed in the MOTION study, its multicenter clinical trial evaluating the safety and effectiveness of Cartiva Synthetic Cartilage Implant (SCI) for the treatment of osteoarthritis of the first MTP joint. The MOTION study represents the largest prospective, randomized clinical study performed to date for this clinical condition.

“Cartiva SCI has the potential to be a game-changer for those suffering from the debilitating pain of this condition but who wish to maintain motion in their joint”

“The completion of the MOTION study is an important milestone for the Company and our technology that puts us one step closer to a potential new alternative for patients with osteoarthritis of the first MTP joint,” said Timothy J. Patrick, president and chief executive officer of Cartiva. “We have commenced final data analysis and look forward to presenting the results next year.”

“Cartiva SCI has the potential to be a game-changer for those suffering from the debilitating pain of this condition but who wish to maintain motion in their joint,” said Judith F. Baumhauer, M.D., 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 MOTION study. “The MOTION study was a very well designed study conducted by leading foot and ankle surgeons in Canada and the United Kingdom, and should provide us a wealth of clinically significant data on this promising technology.”

In April 2014, the Food and Drug Administration agreed to a modular review process for Cartiva’s premarket approval (PMA) application for Cartiva SCI. The Company has submitted three of the five planned modules, and will submit the final module, including the data from the MOTION study, in the second quarter of 2015.

Study Design

The MOTION study, which completed enrollment in June 2012, is a 236 patient, randomized, prospective study conducted at 12 sites in Canada and the United Kingdom where patients were followed for two years. Patients were randomized to receive a Cartiva implant or arthrodesis (joint fusion), the current standard of care for reducing the debilitating pain associated with osteoarthritis of the MTP joint in the great toe. The primary endpoint for the study is a composite evaluation of three study outcomes – Pain as measured by a Visual Analog Scale (VAS), function as measured by the Foot and Ankle Ability Measure (FAAM) Sports sub-scale score, and absence of key safety events. Secondary endpoints include great toe range of motion, VAS pain and return to function as measured by the FAAM Activities of Daily Living Score.

About Osteoarthritis of the first MTP Joint

Also known as hallux rigidus, osteoarthritis of the first MTP joint is the most common site of osteoarthritis (OA) in the foot, affecting one in 45 Americans over the age of 50, or approximately 2 million people. The MTP joint, which serves the function of pushing the foot away from the ground when walking, can become painful and stiff when affected by arthritis, leading patients to make adjustments to their movement that can have an adverse impact on other joints or lead to a more sedentary lifestyle.

The current standard of care for moderate to severe osteoarthritis of the first MTP joint is arthrodesis, a procedure involving removal of cartilage, bone resection and fusion of the joint using plates and screws. The main advantage of this procedure is that it is a permanent correction and usually successful in the elimination of the arthritis pain. The major disadvantage is the restriction of movement of the big toe and the resulting limitations on certain daily activities, sports and footwear. Cartiva SCI, made from polyvinyl alcohol (PVA) is designed to replace the damaged cartilage surface. Through a proprietary manufacturing process, Cartiva SCI is designed to mimic the properties of natural cartilage.

About Cartiva, Inc.

Based in Alpharetta, Ga., Cartiva, Inc. develops and markets innovative solutions for patients with osteoarthritis or cartilage damage. Cartiva’s primary investor is New Enterprise Associates. Additional information is available on the Company’s website at www.cartiva.net.