Funds will support IDE clinical study for company's Agili-C™ implant
CartiHeal (2009) Ltd., developer of a cell-free, off-the-shelf implant for use in cartilage and osteochondral defects, announced today the culmination of an $18.3M financing round. The funds will finance the company's recently-approved IDE clinical trial toward a PMA application.
The two-year pivotal study will involve US and OUS centers, with the aim of demonstrating the Agili-C™ implant's superiority over the surgical standard of care.
The investment was led by aMoon, together with CartiHeal's existing investors: Johnson & Johnson Innovation (JJDC Inc.), Peregrine Ventures and Elron, who has been consistently supporting and investing in CartiHeal over the years.
"CartiHeal delivers hope to those who suffer daily from degenerative and non-degenerative joint conditions, regenerating both bone and cartilage with its Agili-C single-step implantation procedure," says Dr. Yair Schindel, Managing Partner at aMoon. "We are excited to take part in this promising endeavor, already showing remarkable results, and join the highly capable management team and strong investors, in bringing this technology to a growing population of patients globally."
"This latest investment round is yet another testament to our investors' confidence in our technology," says Nir Altschuler, CartiHeal's founder and CEO. "We believe the implant can greatly benefit patients suffering from a variety of cartilage lesions, who wish to return to a painless and active lifestyle, and who currently don't have good alternatives."
CartiHeal's cell-free, off-the-shelf implant for use in cartilage and osteochondral defects was implanted in a series of clinical trials conducted in leading centers in Europe and Israel, in over 250 patients with cartilage lesions in the knee, ankle, and great toe. In these trials, the implant was used to treat a broad spectrum of cartilage lesions, as per its CE Mark, from single focal lesions to multiple and large defects in patients suffering from osteoarthritis.
Results of these prior investigations demonstrated the potential for cartilage regeneration and the remodeling of underlying subchondral bone, along with pain and symptom relief.
CartiHeal, a privately-held medical device company headquartered in Israel, develops proprietary implants for the treatment of cartilage and osteochondral defects in traumatic and osteoarthritic joints.
The company's flagship product, Agili-C™, is CE marked and has been recently approved by the FDA for an Investigational Device Exemption (IDE) clinical trial toward a PMA application.