CartiHeal, developer of the proprietary Agili -C implant for the treatment of joint surface lesions in traumatic and osteoarthritic joints, has secured an additional $15 million equity investment from Bioventus, a global leader in orthobiologics. The investment follows the recently completed enrollment and outcome of interim analysis in CartilHeal’s investigational device exemption (IDE) multinational pivotal study. An additional $5 million can be secured by CartiHeal from Bioventus, if needed, for IDE study completion.
This new round of funding is expected to enable CartiHeal to complete all patient follow-up in the study and submit a first application for premarket approval (PMA) to the FDA. Bioventus made an initial $2.5 million investment in the Agili-C IDE study in January 2018, as part of a previous financing round.
Bioventus and CartiHeal have agreed on an option structure under which Bioventus will acquire the company shortly after FDA approval of the Agili-C implant. Terms of that option structure are not disclosed.
“We are pleased Bioventus continues to see value in the Agili-C implant and is making a greater investment to support the completion of the IDE study,” said Nir Altschuler, founder & CEO, CartiHeal. “We look forward to the work ahead and a successful application for PMA approval.”
“The successful enrollment and outcome at the interim analysis of CartiHeal’s pivotal study for Agili-C implant is an important milestone,” said Ken Reali, CEO, Bioventus. “It is a testament to the strength of its continuing development program and more importantly the future potential of the Agili-C technology in addressing the large unmet need in patients with joint surface lesions. This investment underscores our belief in the novel technology and we look forward to working with the team at CartiHeal in the years to come.”
CartiHeal, a privately-held medical device company with headquarters in Israel, develops proprietary implants for the treatment of cartilage and osteochondral defects in traumatic and osteoarthritic joints.
About the Agili-C implant IDE multinational pivotal study
The trial’s objective is to demonstrate the superiority of the Agili-C implant over the surgical standard of care (microfracture and debridement) for the treatment of cartilage or osteochondral defects, in both osteoarthritic knees and knees without degenerative changes. It includes more than 250 patients in centers in the US, Europe and Israel.
Bioventus is an orthobiologics company that delivers clinically proven, cost-effective products that help people heal quickly and safely. Its mission is to make a difference by helping patients resume and enjoy active lives. The orthobiologic products from Bioventus include offerings for osteoarthritis, surgical and non-surgical bone healing. Built on a commitment to high quality standards, evidence-based medicine and strong ethical behavior, Bioventus is a trusted partner for physicians worldwide.