13 Oct CartiHeal Receives FDA “Breakthrough Device Designation” for the novel Agili-C Implant
Breakthrough Designation Allows Expedited Review
KFAR SABA, Israel, Oct. 12, 2020 /PRNewswire/ — CartiHeal, developer of Agili-C™, a proprietary implant for the treatment of cartilage lesions in arthritic and non-arthritic joints, announced today that FDA has granted Breakthrough Device Designation for the Agili-C implant™.
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.
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.”
CartiHeal, a privately-held medical device company headquartered in Israel and New Jersey, develops proprietary implants for the treatment of cartilage and osteochondral defects in traumatic and osteoarthritic joints.
CartiHeal’s cell-free, off-the-shelf implant is CE marked for use in cartilage and osteochondral defects. Agili-C™ has been implanted in over 500 study patients with knee, ankle, and great toe cartilage lesions in a series of clinical trials at leading centers in Europe and Israel – treating a broad spectrum of cartilage lesions, from single focal lesions to multiple and large defects in osteoarthritic patients.
In the United States, the Agili-C™ implant is not available for sale – it is an investigational device limited to use in the IDE clinical study.
For more information: www.cartiheal.com