KFAR SABA, ISRAEL; LSU, New Orleans, USA – CartiHeal, developer of Agili-C, proprietary implant for the treatment of joint surface lesions; Principle Investigator Dr. Vinod Dasa, Sports Medicine & Arthroplasty Specialist, Vice Chairman academic affairs at LSU; and Dr. Michael Hartman, Associate Professor of Orthopedic Surgery at LSU, announced today the successful enrollment of the first two US patients in the Agili-C IDE pivotal study.
The Agili-C IDE study is revolutionizing the way health care providers look at chronic knee pain. For patients who are not eligible for knee replacements, the Agili-C implant and procedure can alleviate debilitating knee pain in a way no other treatment plan has been able to before.
“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 Dr. 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 active lifestyle.”
The first US patient to receive an Agilli-C implant came to LSU and was a 53-year-old male. This patient suffered from a chronic painful cartilage lesion in the trochlea’s center of the knee and the patient received a single implant through a minimally invasive surgery method, mini-arthrotomy.
80 patients worldwide have been enrolled and treated in the study, which will include a minimum of 250 patients in US and OUS centers, with a goal of an FDA PMA application.
Nir Altschuler, Cartiheal’s founder & CEO said: “We would like to congratulate Dr. Dasa and Dr. Hartman for enrolling the first two US 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 US sites in the near future.”
The trial’s objective is to demonstrate the superiority of the Agili-C implant over the current surgical standard of care (microfracture and debridement) for the treatment of cartilage or osteochondral defects, in both arthritic knees and knees without degenerative changes.
About the Agili-C Implant
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. 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.
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.