KFAR SABA, Israel, Aug. 7, 2019 /PRNewswire/ -- CartiHeal, developer of Agili-C™, a proprietary implant for the treatment of cartilage lesions in arthritic and non-arthritic joints, announced today the successful enrollment and operation of the first two patients in the Agili-C™ Investigational Device Exemption (IDE) pivotal study at Hospital for Special Surgery (HSS), New York, NY. The surgeries were performed by site Principal Investigator Prof. Andreas Gomoll, MD, a sports medicine orthopedic surgeon.
The multi-site clinical study will involve a minimum of 250 patients, which 228 patients have already been enrolled.
HSS is one of 15 U.S. clinical sites participating in this randomized and controlled Food and Drug Administration (FDA) IDE clinical study. The primary study objective is to show superiority of the Agili-C™ cartilage regeneration implant over the current standards of care: microfracture and debridement.
"I was very pleased that my first two patients in the clinical study were both randomized to the Agili-C™ arm. The first patient had mild osteoarthritis and osteochondral defect on the load bearing area of the medial femoral condyle and was treated with a single Agili-C™ implant. The second patient, also with mild osteoarthritis, had two symptomatic lesions located at the center of the trochlea and on the load bearing area of the medial femoral condyle and was treated with two Agili-C implants," said Prof. Gomoll.
"The two procedures went smoothly and I look forward to enrolling more patients into this important clinical study in the upcoming weeks," concluded Prof. Gomoll.
CartiHeal's founder and CEO Nir Altschuler states: "We are excited that Prof. Gomoll has joined our clinical study as a principal investigator. Prof. Gomoll is one of the most prestigious cartilage surgeons and we expect that his impact on the clinical study will be very significant."
"With top institutions, such as HSS involved in the clinical study, and with 228 patients already enrolled out of 250 patients planned, we hope to meet the clinical study's endpoint and provide a viable treatment option to millions of patients in need."
To find out if you qualify for this study please visit http://www.cartiheal.com
CartiHeal, a privately-held medical device company headquartered in Kfar Saba, Israel and New Jersey, USA, develops proprietary implants for the treatment of cartilage and osteochondral defects in traumatic and osteoarthritic joints.
CartiHeal's cell-free, off-the-shelf implant is CE marked for use in cartilage and osteochondral defects. Agili-C™ has been implanted in over 400 patients with cartilage lesions in the knee, ankle and great toe in a series of clinical studies conducted in leading centers in Europe and Israel. In these clinical studies, the Agili-C™ 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.