CartiHeal, developer of Agili-C, a proprietary implant for the treatment of joint surface lesions, and two LSU Health New Orleans orthopaedic surgeons announced today the successful enrollment of the first two U.S. patients in the Agili-C IDE pivotal study. The first two cases in the United States were performed by Principle Investigator Dr. Vinod Dasa, associate professor and director of orthopaedic research, and Dr. Michael Hartman, associate professor of orthopaedic surgery at LSU Health New Orleans School of Medicine, on Aug. 14, 2018.
The first patient who was randomized to receive an Agili-C implant in the United States is a 53-year-old male. He suffered from a chronic painful cartilage lesion in the trochlea's center and received a single implant in a mini-arthrotomy approach.
"Currently we lack good treatment options for patients who experience persistent knee pain due to cartilage problems and are too young for knee replacement" said Dasa. "The Agili-C implantation was smooth without complications. We plan to enroll more patients in the upcoming weeks and hope that this lDE trial finds that the Agili-C implant alleviates pain in these patients, allowing them to return to an active lifestyle."
In Europe and Israel, 80 patients have already been enrolled and treated in the study, which will include a minimum of 250 patients in U.S. and O.U.S. centers, aiming for an FDA PMA application. 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 both arthritic knees and knees without degenerative changes.
Nir Altschuler, Cartiheal's founder & CEO said, "We would like to congratulate Dr. Dasa and Dr. Hartman for enrolling the first two U.S. patients. This is a significant milestone for our company and for our study. We are very pleased with the enrollment rate to date, and plan to open more U.S. sites in the near future."
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 more than 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.