The sale of Cartiheal to Bioventus can now go through. In August of 2021 Bioventus, an American orthologics company, exercised an option that it held to acquire Israeli medtech company CartiHeal for as much as $500 million. But the deal was contingent on U.S. Food and Drug Administration (FDA) has granted Premarket Approval (PMA) for its Agili-C™ implant. That approval has now been given.
CartiHeal is a privately-held Israeli medical device company that develops proprietary implants for the treatment of cartilage and osteochondral defects in traumatic and osteoarthritic joints. The Agili-C™ implant is indicated for the treatment of an International Cartilage Repair Society (ICRS) grade III or above knee-joint surface lesion(s), with a total treatable area of 1-7cm2, without severe osteoarthritis (Kellgren-Lawrence grade 0-3).
The Mayo Clinic explains that Osteochondritis dissecans (os-tee-o-kon-DRY-tis DIS-uh-kanz) is a joint condition in which bone underneath the cartilage of a joint dies due to lack of blood flow. This bone and cartilage can then break loose, causing pain and possibly hindering joint motion.
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Osteochondritis dissecans occurs most often in children and adolescents. It can cause symptoms either after an injury to a joint or after several months of activity, especially high-impact activity such as jumping and running, that affects the joint. The condition occurs most commonly in the knee, but also occurs in elbows, ankles and other joints.
CartiHeal offers a cell-free, off-the-shelf implant, 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 trials conducted in leading centers in Europe and Israel. 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.
“The 2-year study results, which demonstrated superiority of the Agili-C™ implant over the current surgical standard of care, offers an important potential benefit to millions of patients”, said Nir Altschuler, CartiHeal’s founder and CEO. “This milestone achievement was made possible due to the support of our regulatory advisors, Hogan Lovells, our statistical consultants, Biomedical Statistical Consulting, and the many dedicated investigators and patients who participated in our studies. We are grateful for all their help. FDAs approval enables us to initiate commercialization and provide a superior solution for patients compared to the current standard of care options.”