Orthobiologics company Bioventus, LLC has just announced a $15 million equity investment in CartiHeal, Inc., a privately held medical device company.
Bioventus Announces $15 Million Equity Investment in CartiHeal
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OTW spoke with Bioventus Chief Executive Officer Ken Reali regarding CartiHeal and what it was that appealed to Bioventus. He told OTW, “We are a market leader in the HA [hyaluronic acid] therapy sector and view the CartiHeal technology as a natural extension as it is on the same clinical continuum for treatment of mild to moderate OA [osteoarthritis] and leverages our commercial expertise.”
CartiHeal developed Agili-C™, an implant to treat joint surface lesions in traumatic and osteoarthritic joints. In a recent study, the Agili-C implant showed promising regenerative capacity.
The investment follows CartiHeal’s recent investigational device exemption (IDE) study. If necessary, CartiHeal can secure an additional $5 million from Bioventus for IDE study completion.
In January 2018, in a previous financing round, Bioventus made a $2.5 million investment in the Agili-C IDE study. This new round of financing should enable CartiHeal to complete all patient follow-up in the study and submit its application for premarket approval (PMA) to the U.S. Food and Drug Administration (FDA).
Upon FDA approval of the Agili-C implant, Bioventus will acquire CartiHeal in an agreed upon option structure. The companies have not disclosed the terms of the option structure.
CartiHeal Founder and Chief Executive Officer Nir Altschuler commented on Bioventus’ investment, “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.”
Altschuler continued, “We look forward to the work ahead and a successful application for PMA [pre market approval] approval.”
OTW has been following the impact of the Agili-C implant on cartilage repair. For OTW’s recent coverage of the Agili-C implant, see “First Peek at Agili-C’s Interim Study Results” and “Landmark Cartilage Repair Study Nearing Enrollment.”
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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