According to a Two-Year Randomized and Controlled Multinational IDE Study
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
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.
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."
About CartiHeal
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.
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