Israel-based CartiHeal announced last week that they have opened a multi-center IDE study that will evaluate the use of their Agili-C implant against microfracture and debridement for the treatment of cartilage or osteochondral defects. Seventeen subjects have been enrolled and treated at three EU centers so far, and the company is in the process of opening additional sites in the EU, U.S. and Israel. The study will enroll a minimum of 250 subjects overall and be used to support a U.S. PMA application. The device is CE marked in Europe.
Agili-C is described as a cell-free, off-the-shelf implant that aims to regenerate damaged hyaline cartilage, thus preventing progression to osteoarthritis. The implant is biphasic, consisting of modified aragonite and hyaluronic acid in the cartilage phase and calcium carbonate in the bone phase, and is implanted in a press-fit, single-stage procedure.