Bioventus made an additional equity investment of $15 million in CartiHeal, developer of the Agili™-C implant for the treatment of joint surface lesions in traumatic and osteoarthritic joints. The investment follows the recently completed enrollment and outcome of interim analysis in CartilHeal’s multinational pivotal Investigational Device Exemption (IDE) study. An additional $5 million can be secured by CartiHeal from Bioventus, if needed, for IDE study completion.
Funding will support completion of patient follow-up in the study and submission of an application for premarket approval to FDA. Bioventus made an initial $2.5 million investment in the Agili-C IDE study in 2018, as part of a previous financing round.
Bioventus and CartiHeal have agreed on an option structure under which Bioventus will acquire the company following FDA approval of the Agili-C implant.
“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 of 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.”