Hadassah Medical Center, Mount Scopus, Jerusalem – For the first time in Israel, an innovative implant designed to repair cartilage lesions has been implanted in the framework of a pivotal trial. The implant, Agili-C, developed by CartiHeal, is currently being tested in an international, multicenter and randomized controlled trial. (The patient knows what treatment he has been given.) To date, about 80 patients in leading hospitals abroad have been recruited for the trial, out of 250 planned patients.
The patient is a 30-year-old who has undergone several operations to repair knee cartilage injury without success. After being randomly assigned to the implant group, she was successfully operated on yesterday by Dr. Adi Friedman, director of the Center for Arthroscopic Surgery and Sports Injuries, of the Department of Orthopedic Surgery at Hadassah.
“The need for an implant that leads to the re-growth of damaged cartilage is a real need in the orthopedic field, and we hope the experiment will succeed, and that the implant will be the breakthrough that we have waited for, for many years,” Dr. Friedman said. “The transplant went smoothly, and I am hopeful that the patient will soon return to a fully functional and pain-free life. We intend to recruit more patients for research. “
Cartiheal, an Israeli start-up founded and managed by Nir Altschuler, specializes in regenerative medicine, and its flagship product is Agili-C, a natural calcium-carbonate implant derived from coral that promotes healing and regrowth of cartilage and bone tissue.
To date, more than 400 patients have been treated with this implant, mainly in Europe. The company is in the midst of recruiting patients for the clinical trial with a goal to receive approval for the implant from the US Food and Drug Administration (FDA). The trial includes centers in the United States, Europe and Israel, with the aim of proving the advantage of Agili-C implants compared with the standard of care treatments currently in place with limited efficacy.
Altschuler said, “We congratulate Dr. Friedman and his team on the first implantation in Israel, as part of the pivotal study of the implant we developed. The transplant was performed professionally and at the highest level. We intend to include additional centers in Israel in the coming months. “
Nir Altschuler founded CartiHeal in 2009, in collaboration with Ben Gurion University. The company operates from Kfar Sava, Israel, and employs 30 people. The Agili-C implant has received European CE certification and has already been implanted in 400 patients in centers in Europe.
Investors in the company include Elron of the IDB Group, Accelmed Fund, Access Medical Ventures, Peregrine Ventures, and the aMoon Fund of Marius Nacht and Dr. Yair Schindel, as well as the strategic investors J & J (through the JJDC investment arm) and Bioventus.