The US Food and Drug Administration (FDA) has approved CartiHeal's investigational device exemption (IDE) application for Agili-C implant to treat joint surface lesions.
The company will carry out a two-year trial, which has been designed to demonstrate superiority of the Agili-C implant over surgical standard of care such as microfracture and debridement to treat cartilage/osteochondral defects in both osteoarthritic knees and in knees without degenerative changes
The trial, which will recruit around 250 patients in the US and OUS centers, will involve up to three lesions in the same joint with a total treatable area of 1-7cm2.
CartiHeal implanted Agili-C in a series of clinical trials carried out centers in Europe and Israel, in over 220 patients with cartilage lesions in the knee, ankle and great toe.
Based on its CE mark, the implant was used to treat a wide spectrum of cartilage lesions ranging from single focal lesions to multiple and large defects in patients suffering from osteoarthritis.
According to the company, the results of the prior investigations showed the potential for cartilage regeneration and remodeling of the underlying subchondral bone along with pain and symptom relief.
CartiHeal founder and CEO Nir Altschuler said: “Together with our Clinical Advisory Board we designed a study that targets a large patient population who can potentially benefit from this implant.
“We are very pleased that FDA approved our study design, and believe that the Agili-C implant will prove to be an ideal treatment for a variety of cartilage lesions in patients who wish to return to a painless and active lifestyle, and currently don't have good alternatives."
CartiHeal is involved in the development of proprietary implants to treat cartilage and osteochondral defects in traumatic and osteoarthritic joints.