KFAR SABA, Israel, Aug. 3, 2021 /PRNewswire/ -- CartiHeal Ltd, developer of Agili-C™, a proprietary implant for the treatment of cartilage lesions in arthritic and non-arthritic joints, which was granted Breakthrough Device Designation by the FDA last year, announced today two-year results of the pivotal IDE Study. The Agili-C™ clinical study was conducted to test the potential superiority of the Agili-C™ implant over the current Surgical Standard of Care (SSOC) – microfracture and debridement, for the treatment of joint surface lesions, chondral and osteochondral defects, in the knee joint. The IDE study is a multicenter, 2:1 randomized, open-labeled and controlled trial. 251 Subjects, 167 in the Agili-C™ arm and 84 in the SSOC arm, were enrolled in 26 sites in the US and outside the US.
The primary endpoint for this study was the change from baseline to 24 months in average of the 5 subscales of the Knee injury and Osteoarthritis Outcome Score (KOOS Overall): Pain, Other Symptoms, Quality of Life - QOL, Activities of Daily Living - ADL and Sports. The KOOS Overall Score ranges from 0 to 100, where higher values represent better outcomes.
The data generated from this trial demonstrated superiority of Agili-C™ to the current surgical standard of care (debridement or microfracture, SSOC). The Bayesian posterior probability of superiority at Month 24 was determined to be 1.000, exceeding the prespecified threshold of 0.98 required to demonstrate superiority.
The baseline KOOS Overall score was similar in both groups: 41.2 in the Agili-C™ arm and 41.7 in the SSOC arm. At Month 24, the posterior mean for the treatment group improvement from baseline in the Agili-C™ arm was 42.7 compared to 21.4 for the SSOC arm.
The degree of improvement for Agili-C™ compared to SSOC was similar for subjects with Mild-moderate Osteoarthritis (Kellgren-Lawrence Grades of 2 or 3) and for subjects with Large Lesions (total lesion areas larger than 3 cm2).
The posterior probability of superiority of Agili-C™ relative to SSOC was also 1.000 for all 4 Secondary Confirmatory Endpoints: KOOS Pain, KOOS ADL and KOOS QOL and Responder Rate.
The responder rate, which was a-priori defined as improvement of at least 30 points in Overall KOOS at 24 months compared to baseline, was 77.8% in the Agili-C™ arm compared to 33.6% in the SSOC arm.
According to Dr. Ken Zaslav, CartiHeal's Chief Medical Officer and past President of the International Cartilage Repair Society (ICRS) "the idea of the study design was to treat patients that we, as orthopedic surgeons, see on a daily basis in our clinics and operating rooms. This is the first multinational, randomized and controlled study which enrolled subjects with such a wide range of indications. We are very pleased with the fact that the top knee surgeons in the world have elected to participate in this important IDE clinical study".
"Study results, which demonstrate the superiority of the Agili-C™ implant over the current surgical standard of care, offers an important potential benefit, as reflected in our Breakthrough Designation by the FDA, for patients who lack other sufficient treatment options", said Nir Altschuler, CartiHeal's founder and CEO. "We are looking forward to working closely with the FDA and plan to submit the PMA application later this year."
CartiHeal, a privately-held medical device company headquartered in Israel and New Jersey, develops proprietary implants for the treatment of cartilage and osteochondral defects in traumatic and osteoarthritic joints.
CartiHeal's cell-free, off-the-shelf implant is CE marked for use in cartilage and osteochondral defects. Agili-C™ has been implanted in over 500 study patients with knee, ankle, and great toe cartilage lesions in a series of clinical trials at leading centers in Europe and Israel – treating a broad spectrum of cartilage lesions, from single focal lesions to multiple and large defects in osteoarthritic patients.
In the United States, the Agili-C™ implant is not available for sale – it is an investigational device limited to use in the IDE clinical study.