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.”