KFAR SABA, Israel and BUDAPEST, Hungary, September 17, 2018 /PRNewswire/ --
CartiHeal, developer of the Agili-C implant for the treatment of joint surface lesions, and the Principle Investigator Professor László Hangody, of the Uzsoki Street Hospital, announced today the successful enrollment of the first Hungarian patient in the Agili-C IDE pivotal study.
"I'm excited to take part in this Pivotal study," said Prof. Hangody. "I have great hopes that this study will demonstrate the superiority of this novel implant over the current surgical standard of care. My first patient in the study, a highly competitive 25 -year-old sportswoman, was randomized to the Agilli-C arm. The patient had a painful osteochondral defect at the load bearing area of the Medial Femoral condyle and was treated with a single implant."
Nir Altschuler, CartiHeal's founder & CEO said, "Prof. Hangody is a prominent surgeon with vast experience in cartilage repair, it is a great honor that he is participating as an Investigator in the Agili-C IDE study." Altschuler added that the IDE study is currently ongoing in the US, EU and Israel, aiming for an FDA PMA application, with over 80 patients already enrolled. "The trial's objective is to demonstrate the superiority of the Agili-C implant over surgical standard of care (microfracture and debridement) for the treatment of cartilage or osteochondral defects, in arthritic knees and also in knees without degenerative changes."
CartiHeal's cell-free, off-the-shelf implant is CE marked for use in cartilage and osteochondral defects. Agili-C has already been implanted in a series of trials conducted in leading centers in Europe and Israel, in over 400 patients with cartilage lesions in the knee, ankle or 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.
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.
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.