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Agili-C Implant Receives FDA Breakthrough Device Designation: 251 Subjects Enrolled In IDE Clinical Study at 26 Sites in US, Europe and Israel

October 12, 2020

Agili-C implant has received FDA Breakthrough Device Designation. CartiHeal announced the news today. FDA’s Breakthrough Device Program is reserved for certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. This program is intended to help patients receive more timely access to these medical devices by expediting their development, assessment and review by FDA.

Agili-C Implant Device Receives Fda Breakthrough Device Designation

CartiHeal is currently conducting a pivotal IDE clinical study which is designed to evaluate the Agili-C™ implant superiority over the current surgical standard of care – microfracture and debridement. In total 251 Subjects were enrolled in 26 sites in the US, Europe and Israel. The study includes Subjects with both mild to moderate osteoarthritis and focal defects, without arthritic changes. 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.”

SourceCartiHeal
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