Medical device and MedTech insights, news, tips and more

CartiHeal Receives FDA “Breakthrough Device Designation” for the novel Agili-C Implant

October 12, 2020

agilic

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.

the Cartiheal Agili-C implant on a white background

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.”

About CartiHeal

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.

See Full Press Release at the Source: CartiHeal Receives FDA “Breakthrough Device Designation” for the novel Agili-C Implant


Press Release by: CartiHeal


Legacy MedSearch has more than 30 years of combined experience recruiting in the medical device industry. We pride ourselves on our professionalism and ability to communicate quickly and honestly with all parties in the hiring process. Our clients include both blue-chip companies and innovative startups within the MedTech space. Over the past 10 years, we have built one of the strongest networks of device professionals ranging from sales, marketing, research & , quality & regulatory, project management, field service, and clinical affairs.

We offer a variety of different solutions for hiring managers depending on the scope and scale of each individual search. We craft a personalized solution for each client and position with a focus on attracting the best possible talent in the shortest possible time frame.

Are you hiring?
Contact us to discuss partnering with Legacy MedSearch on your position.

More insights

November 11, 2024
What is the Difference Between MedTech and TechMed?  
Learn More
March 7, 2024
FDA Clears Dexcom’s First Over-the-Counter Continuous Glucose Monitor
Learn More
March 1, 2024
FDA greenlights Boston Scientific’s Novel Drug-Coated Balloon for Coronary In-Stent Restenosis
Learn More

Begin your legacy now. We are your medtech and medical device talent advisory firm.