First Hungarian patient enters Agili-C implant study
CartiHeal, developer of the Agili-C implant for the treatment of joint surface lesions, together with principle investigator Professor László Hangody of the Uzsoki Street Hospital, announced today the successful enrollment of the first Hungarian patient in the Agili-C investigational device exemption (IDE) pivotal study.
Prof. László Hangody
"Iʼm excited to take part in this pivotal study," said Hangody, according to a press release sent to the Budapest Business Journal. "I have great hopes that this study will demonstrate the superiority of this novel implant over the current surgical standard of care."
The first patient in the study was described as a highly competitive 25-year-old sportswoman, and was treated with a single implant.
"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," said Nir Altschuler, CartiHealʼs founder and CEO. He added that the IDE study is currently underway in the U.S., EU and Israel, aiming for an FDA PMA application, with over 80 patients already enrolled.
"The trialʼs 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," Altschuler explained.
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. The implant was used in these trials 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.
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