KFAR SABA, ISRAEL; Budapest, Hungary, Uzsoki Street Hospital, – CartiHeal, developer of Agili-C, proprietary implant for the treatment of joint surface lesions, and the Principle Investigator Professor Dr. László Hangody, MD of the Uzsoki Street Hospital, announced today the successful enrollment of the first Hungarian patient in the Agili-C IDE pivotal study.
“Taking part in this study is truly paving the way to address the problem of untreatable cartilage lesions and to better patient’s quality of life by giving them the ability to achieve what they have dreamed – to go back to full movement and active life. During the years, as a leading Orthopedist, I have witnessed the pain and frustration of patients that had to go through the standard surgical treatment of care, without being able to really fix their cartilage.
The innovation in the Agili-C implant, relies on the fact that it is made from a natural source and gives the body the ability to heal itself without further medical interventions. My first patient in the study, a highly competitive 25 -year-old sportswoman, was randomized to the Agilli-C arm and treated with the Agili-C implant. I believe that it is an important step for the Uzsoki Street Hospital, and for me to perform the first Hungarian Agili-C implantation in the IDE Pivotal Study” said Professor Dr. László Hangody.
Nir Altschuler, CartiHeal’s founder & CEO said: “Adding Hungary to the countries in our multinational IDE Study is very exciting. Prof. Hangody is a highly qualified professional and a leading surgeon in Hungary and the Uzsoki Street Hospital, is one of the main Hospitals in Hungary.
We are honored have him in the study and look forward to the active enrollment of patients in the study and the full collaboration with Professor Dr. László Hangody”.
Altschuler also added that the IDE study is currently ongoing in the US, EU and Israel, aiming for a FDA PMA application with over 80 patients that have been 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 was 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 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.
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.