Israel-based CartiHeal has received breakthrough device designation from the Food and Drug Administration (FDA) for its Agili-C implant.
Agili-C is an implant for the treatment of cartilage lesions in arthritic and non-arthritic joints.
The FDA has launched its breakthrough device programme for medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.
It is intended to help patients receive more timely access to such medical devices by accelerating their development, assessment and review by the agency.
CartiHeal founder and CEO Nir Altschuler said: “We are extremely pleased that FDA granted the Agili-C implant breakthrough device designation.
“We look forward to working closely with FDA to expedite Agili-C’s review process, once the final IDE study results will be available in order to provide a promising treatment for millions of patients who suffer from cartilage defects and currently lack good treatment options.”
A pivotal IDE clinical study is being conducted by CartiHeal to assess the superiority of Agili-C implant over the microfracture and debridement, which are the existing surgical standard of care.
The study has enrolled 251 subjects in 26 sites in the US, Europe and Israel. The subjects include patients with both mild to moderate osteoarthritis and focal defects without arthritic changes.
Final study results are expected next year.
As part of the financing round, the companies agreed on an option structure, under which Bioventus will acquire CartiHeal if the company secures the FDA approval for the Agili-C implant.