Jul 16, 2015

Cartiva Announces Positive Final Data from its Cartiva SCI Pivotal Trial for Great Toe Arthritis

Cartiva, Inc., a developer of innovative solutions for the treatment of cartilage damage, osteoarthritis and other musculoskeletal conditions, announced today that it has successfully met the primary endpoint of its pivotal (Phase III) randomized controlled trial evaluating the safety and effectiveness of Cartiva Synthetic Cartilage Implant (SCI) for the treatment of osteoarthritis of the first metatarsophalangeal (MTP) joint, the most common arthritic condition of the foot. The objective of the MOTION study, which involved 197 patients treated at 12 centers, was to establish non-inferiority of Cartiva SCI compared to fusion.

Joint fusion is the historical standard of care for the treatment of advanced arthritis in the great toe. While fusion provides durable pain relief, it does so by eliminating joint motion with plates or screws and requires a lengthy recovery period to allow the bones to fuse. The study demonstrated that Cartiva SCI patients can expect durable pain reduction and functional improvement as with arthrodesis, but with a statistically significant improvement in range of motion and a quicker return to function and activities of daily living.

The data was presented this morning at the Annual Meeting of the American Orthopaedic Foot and Ankle Society by Judith F. Baumhauer, MD, Associate Chair of Academic Affairs and Professor, Division of Foot and Ankle Surgery, Department of Orthopaedic Surgery at the University of Rochester and Principal Investigator for the MOTION study. Dr. Baumhauer’s abstract entitled Prospective, Randomized, Multi-Centered Clinical Trial Assessing Safety and Efficacy of a Synthetic Cartilage Implant versus First Metatarsophalangeal Arthrodesis in Advanced Hallux Rigidus was awarded the prestigious Roger A. Mann Award, given in recognition of the outstanding clinical paper presented at the meeting. Nominated studies are selected by the AOFAS Program Committee from blind review of abstracts submitted for consideration for the scientific program. The award, established in 1994 by Dr. Mann's fellows, is presented to the senior author. “These positive results from the MOTION study validate the work of our company and the surgeons who played a critical role in evaluating this new therapy,” said Tim Patrick, President and CEO of Cartiva. “Seeing these positive results from our rigorous study honored at North America’s premier Foot & Ankle surgeons’ meeting is a significant milestone for our company.”

Study Design
The MOTION study was a randomized, prospective study for MTP arthritis conducted at 12 sites in Canada and the United Kingdom where all patients were followed for 24 months. Patients were randomized 2:1, Cartiva implant to arthrodesis (joint fusion), the historical 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 was a composite 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.

The individual subject’s outcome was considered a success if all of the following pre-specified criteria were met: (1) improvement from baseline of ≥ 30% as measured by the VAS; (2) maintenance of function from baseline as measured by the FAAM sports score; and, (3) absence of major safety events and subsequent secondary surgical interventions.

Study Results
The analysis of effectiveness was based on the Primary Analysis Population: 132 randomized Cartiva subjects, and 65 arthrodesis subjects. The proportion of successes in each group was determined and the difference (Cartiva minus arthrodesis) and one-sided 95% confidence interval for the difference between treatment groups was calculated.

Utilizing the primary analysis of intent-to-treat (ITT), which includes all randomized subjects utilizing last observation carried forward (LCOF) for missing data, 79% (104/132) of the subjects in the Cartiva arm met the definition of success compared to 62% (40/65) of subjects in the arthrodesis control arm, demonstrating non-inferiority (p <0.0001).Utilizing the modified intent-to-treat (mITT) study population, which includes all randomized and treated patients utilizing LCOF for missing data, 80% (104/130) of the patients in the Cartiva arm met the definition of subject success compared to 80% (40/50) of subjects in the arthrodesis control arm, demonstrating non-inferiority (p=0.0075).

The analyses of secondary efficacy demonstrate a change that is statistically and clinically meaningful for both treatment groups for all secondary endpoints evaluated. Cartiva subjects demonstrated a quicker return to function as evidenced by a statistically significant improvement over arthrodesis at 6 weeks in FAAM Sports and SF-36 Physical Function scores. The improvements in pain and function experienced by both Cartiva and arthrodesis subjects were durable over the course of the MOTION study (24 months). Cartiva subjects showed a 79% improvement in VAS pain scores and 110% improvement in FAAM Sports Scores at 24 months that well exceeded the minimal clinically important difference (MCID). The incidence of secondary surgical interventions (11%) for the Cartiva subjects and (12%) for the Arthrodesis subjects was comparable and the small incidence of Cartiva subjects requiring removal were easily and successfully converted to arthrodesis. During the course of the study, there were no clinically important radiographic findings such as wear debris or osteolysis in the Cartiva group as reported with other historic implants such as silicone, plastic or metal devices.

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.

Contact

Cartiva, Inc.
Peter Pizzo, 770-754-3855
Chief Financial Officer

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