US-based orthobiologics firm Bioventus has invested $15m in CartiHeal, and has an option to acquire the Israeli medical device company if its cartilage treatment implant Agili-C secures FDA approval.
This investment comes after the Israeli firm CartiHeal recently completed enrollment and outcome of interim analysis of its investigational device exemption (IDE) multinational pivotal study.
CartiHeal can secure an additional $5m from Bioventus, if required for IDE study completion.
Agili-C is an advanced implant designed to treat cartilage and osteochondral defects in traumatic and osteoarthritic joints.
The IDE study enrolled more than 250 patients, across US, Europe and Israel, and is aimed at showing superiority of the Agili-C implant over the surgical standard of care for the treatment of cartilage or osteochondral defects.
Bioventus invested $2.5m in January 2018 for the IDE study of Agili-C.
New funding to help Cartihealth complete patient follow-up trial
With the new funding round, CartiHeal expects to complete all patient follow-up in the trial and then submit a first application to the FDA to get premarket approval (PMA).
Bioventus CEO Ken Reali said: “The successful enrollment 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.”
Under the terms of the option agreement, Bioventus can acquire CartiHeal if its Agili-C receives FDA approval.
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.”
