American orthobiologics company Bioventus has invested $15m in CartiHeal, an Israel-based developer of Agili-C implant for the treatment of joint surface lesions in traumatic and osteoarthritic joints.
As part of the financing round, the companies have agreed on an option structure, under which Bioventus will acquire CartiHeal if the company secures the Food and Drug Administration (FDA) approval for the Agili-C implant.
In 2018, Bioventus made an initial investment of $2.5m in the CartilHeal’s investigational device exemption (IDE) multinational pivotal study.
The additional $15m equity investment follows the recently completed enrolment and outcome of interim analysis in Agili-C IDE study.
The study aims to demonstrate the superiority of the Agili-C implant over the surgical standard of care for the treatment of cartilage or osteochondral defects.
Over 250 patients were enrolled in the study, which is taking place in the US, Europe and Israel.
CartiHeal intends to use the proceeds from its latest funding to complete all patient follow-up in the study and submit the first application for premarket approval (PMA) to the FDA.
An additional $5m can be secured by the company from Bioventus for IDE study completion if required.
Bioventus CEO Ken Reali said: “The successful enrolment and outcome at the interim analysis of CartiHeal’s pivotal study for Agili-C implant is an important milestone.
“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 founder and CEO Nir Altschuler said: “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.
“We look forward to the work ahead and a successful application for PMA approval.”