CartiHeal said yesterday it launched an FDA investigational device exemption clinical study of its Agili-C implant for repairing cartilage, osteochondral defects and treating joint surface lesions.
A total of 16 patients have been enrolled and undergone operations at European centers in the trial, the Israel-based company said.
The 2-year, 250-patient pivotal study will engage US and international centers and aims to show that the Agili-C is superior over the surgical standard of care for treating cartilage or osteochondral defects in osteoarthritic knees and knees without degenerative changes.
“Enrollment of 16 subjects in such a short time is a promising start to our pivotal study. This reinforces the existence of a significant unmet need. The study was designed to includes patients with a broad range of cartilage lesions, as orthopedic surgeons often see in their clinics. Currently we are working on opening more sites in the US, Europe and Israel,” founder & CEO Nir Altschuler said in a prepared statement.
The company is hopeful that data from the trial will support an FDA premarket approval submission.
“We look forward to seeing the Agili-C implant become a viable solution for the millions of patients who suffer from pain and lack effective treatment options. We have great hopes that the pivotal study will prove Agili-C to be a paradigm shift in treating focal cartilage defects and mild to moderate osteoarthritis,” board chair Dr. Zvika Slovin said in a press release.
In May, CartiHeal said it raised $18.3 million in a new round of financing to support the FDA IDE-approved clinical trial of its Agili-C implant.