The decision is based on a statistical analysis report of Agili-C implant pivotal clinical trial, as well as the reimbursement coding analysis and significant market diligence, including surgeon interviews with respect to Agili-C’s commercialisation opportunity
Active healings solutions provider Bioventus has announced that it is exercising its option to acquire Israel medical device firm CartiHeal.
The company has decided to make a $50m escrow payment to proceed with its option and equity purchase agreement for the acquisition of CartiHeal.
The acquisition decision is based on the assessment of a statistical analysis report of Agili-C implant pivotal clinical trial, as well as the reimbursement coding analysis and significant market diligence.
It also included surgeon interviews with respect to Agili-C’s commercialisation opportunity and ultimate market potential.
Bioventus stated: “The Company’s obligation to consummate the Potential Transaction is subject to the exercise by the Company of the call option provided under the Option Agreement, or the exercise by CartiHeal of its put option provided under the Option Agreement.”
The put option is expected to be exercised following premarket approval (PMA) by the Food and Drug Administration (FDA) of the Agili-C implant and the satisfaction of certain other conditions pursuant to the option agreement.
Agili-C is designated to treat cartilage and osteochondral defects in the knee joint in patients without severe osteoarthritis.
CartiHeal intends to submit the clinical module of its PMA by the end of this year.
The closing of the potential transaction is subject to certain customers following the exercise of such option rights.
Bioventus senior vice president and chief science officer Alessandra Pavesio said: “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 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.”