CartiHeal Agili-C Granted Breakthrough Device Designation

By Julie A. Vetalice

CartiHeal Agili-C Granted Breakthrough Device Designation

FDA granted Breakthrough Device Designation for CartiHeal's Agili-C™, a proprietary implant for the treatment of cartilage lesions in arthritic and non-arthritic joints.

The program is intended to help patients receive more timely access to these medical devices by expediting their development, assessment and review by FDA.

A pivotal Investigational Device Exemption clinical study underway is designed to evaluate superiority of the Agili-C implant's superiority vs. microfracture and debridement, the current standard of care. Final study results are expected next year.

"We are extremely pleased that FDA granted the Agili-C implant Breakthrough Device Designation," said Nir Altschuler, CartiHeal's Founder & CEO. "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."

Product Labels: Orthobiologic Soft Tissue Repair

Tags: Regulatory