CartiHeal, developer of Agili-C, proprietary implants for the treatment of joint surface lesions, announced today the initiation of Its IDE clinical study. 16 patients were enrolled and operated on during the first week of the study in 3 leading European centers.
Agili-C IDE study is set to include a minimum of 250 patients in US and OUS centers, aiming for a PMA submission. The trial's objective is to demonstrate superiority of the Agili-C implant over surgical standard of care (microfracture and debridement) for the treatment of cartilage or osteochondral defects, in both osteoarthritic knees and knees without degenerative changes.
"Enrollment of 16 subjects in such a short time is a promising start to our pivotal study," says CartiHeal Founder and CEO Nir Altschuler. "This reinforces the existence of a significant unmet need. The study was designed to includes patients with a broad range of cartilage lesions, as orthopedic surgeons often see in their clinics. Currently we are working on opening more sites in the US, Europe and Israel".
"We look forward to seeing the Agili-C implant become a viable solution for the millions of patients who suffer from pain and lack effective treatment options", says Dr. Zvika Slovin, Elron's VP of medical devices and Chairman of CartiHeal's BOD. "We have great hopes that the pivotal study will prove Agili-C to be a paradigm shift in treating focal cartilage defects and mild to moderate osteoarthritis."
CartiHeal's cell-free, off-the-shelf implant is CE marked for use in cartilage and osteochondral defects. Agili-C was implanted in a series of trials conducted in leading centers in Europe and Israel, in over 300 patients with cartilage lesions in the knee, ankle and great toe. In these trials, the implant was used to treat a broad spectrum of cartilage lesions, from single focal lesions to multiple and large defects in patients suffering from osteoarthritis.
In the United States the Agili-C implant is not available for sale - it is an investigational device limited for use in the IDE study.
CartiHeal, a privately-held medical device company with headquarters in Israel, develops proprietary implants for the treatment of cartilage and osteochondral defects in traumatic and osteoarthritic joints.