Active healings solutions provider Bioventus has exercised its call option for the acquisition of CartiHeal, developer of the Agili-C implant, in a deal valued at approximately $450m.
The deal includes a payment of nearly $315m, followed by an additional payment of about $135m, which will be made on achievement of $100m in trailing twelve-month sales.
It follows the receipt of a premarket approval (PMA) for the Agili-C implant from the US Food and Drug Administration (FDA) last month.
The device is a cell-free, off-the-shelf implant that has been designed for use in cartilage and osteochondral defects in traumatic and osteoarthritic joints.
It is a solution to delay total knee replacement in patients with knee-joint surface lesions.
The implant is developed to treat International Cartilage Repair Society (ICRS) grade III or above knee-joint surface lesion(s), with a total treatable area of 1cm² to 7cm², without severe osteoarthritis (Kellgren-Lawrence grade 0-3).
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The Agili-C implant, which received Breakthrough Device Designation from the FDA in 2020, is expected to be a cost-effective device developed for bone remodelling and cartilage regeneration.
Bioventus CEO Ken Reali said: “CartiHeal represents an important breakthrough for the treatment of osteoarthritis, and we are excited to bring this complementary product into our growing portfolio of medical devices.
“CartiHeal addresses an unmet need in joint preservation and cartilage regeneration for approximately 675,000 US patients annually, representing an estimated $1.3bn market opportunity for Bioventus.”
The transaction, subject to certain customary closing conditions, is anticipated to be concluded in the second quarter of the year.
In the US, Bioventus is planning for a limited market release (LMR) of CartiHeal during the third quarter of the year.