Leader in healing innovations Bioventus, Inc. has decided to move forward with a $50 million escrow payment, pursuant to a purchase agreement with Kfar Saba, Israel-based CartiHeal Ltd. The payment shows the company’s intent to follow through with its option to acquire CartiHeal and thus CartiHeal’s trademarked product Agili-C™, a proprietary implant for treatment of joint cartilage lesions.
Bioventus Set to Acquire CartiHeal and Agili-C Implant
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Privately-held medical device company CartiHeal develops proprietary implants for cartilage osteochondral and cartilage defect treatment in osteoarthritic and traumatized joints. The company’s innovative Agili-C was granted Food and Drug Administration (FDA) Breakthrough Device Designation last year.
This decision came after review of data related to the Agili-C implant clinical trial and signals the company’s intent to follow through with the official acquisition of CartiHeal. Statistical analysis data, reimbursement coding analysis, market analysis and even surgeon interviews were part of the comprehensive data review.
“The robust data generated from the pivotal clinical trial, a randomized controlled trial with Agili-C, demonstrated superiority over surgical standard of care, microfracture and debridement, in KOOS [Knee Injury And Osteoarthritis Outcome Score] overall compared to baseline. We believe this product could be a strong alternative for the approximately 650,000 US patients annually receiving microfracture or debridement along with other cartilage treatment options,” stated Bioventus Senior Vice President and Chief Science Officer Alessandra Pavesio. “In combination with our HA [hyaluronic acid] products, Agili-C represents an exciting potential new offering for our portfolio designed to address the spectrum of osteoarthritis disease.”
Bioventus is a growing global leader in innovative solutions for active healing and orthosurgical orthobiologics. Based in Durham, North Carolina, with additional international headquarters in Hoofddorp, The Netherlands, Bioventus operates in 30 countries and has over 850 employees globally. With a company mission to “to make a difference by helping patients resume and enjoy active lives,” the company provides clinically sound, cost-effective tools for joint preservation, bone grafting and pain treatment, as well as restorative therapies.
Bioventus intends to work closely with CartiHeal in the coming quarters, in order to be poised to move forward with ease if the potential transaction is completed. The transaction is subject to premarket approval (PMA), FDA approval of the Agili-C implant, and other conditions pursuant to the Option Agreement, as well as customary closing conditions.
CartiHeal is set to submit a clinical module of its PMA later this year.
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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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