KFAR SABA, Israel, Oct. 15, 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 first implantation of the Agili-C™ implant, as part of Investigational Device Exemption (IDE) clinical study by Dr. Jason M. Scopp, orthopedic surgeon and Director of Joint Preservation Center at Peninsula Orthopaedic Clinic in Salisbury, Maryland.
The clinical study will involve a minimum of 250 study patients, currently 241 patients have already been enrolled.
Peninsula Orthopaedic Clinic is one of 15 U.S. clinical sites participating in this randomized and controlled IDE clinical study. The primary study objective is to demonstrate the superiority of the Agili-C™ implant over the current surgical standards of care: microfracture and debridement in the treatment of large spectrum cartilage defects.
"Our first patient was a 50-year-old male with moderate osteoarthritis and with two large cartilage defects in a total surface area of 6.8 cm. One defect was located in the trochlea and the second defect was located on the medial femoral condyle. The patient was randomized to the Agili-C™ treatment arm and was treated with 3 implants.
Patients who have cartilage defects are looking for options to not only treat their pain, but also delay the need for joint replacements," said Dr. Scopp. "I was very pleased that this patient was randomized to the Agili-C group, as I believe it will provide the solution he is seeking. As the Director of the Joint Preservation Center at Peninsula Orthopaedic Associates, I am able to offer my patients the state of the art techniques to preserve their joints and maintain an active lifestyle. I am excited to enroll more patients who meet the inclusion criteria."
CartiHeal's founder and CEO, Nir Altschuler, stated: "We are very pleased that Dr. Scopp has joined our study. With 241 patients already enrolled we are expecting to perform an interim analysis very shortly, once the remaining 9 study patients are enrolled."
CartiHeal, a privately-held medical device company headquartered in Israel and New Jersey, 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 500 study patients with knee, ankle, and great toe cartilage lesions in a series of clinical trials at leading centers in Europe and Israel – treating a broad spectrum of cartilage lesions, from single focal lesions to multiple and large defects in osteoarthritic patients.
In the United States, the Agili-C™ implant is not available for sale – it is an investigational device limited for use in the IDE clinical study.