Bioventus elected to make a $50 million escrow payment pursuant to its Option and Equity Purchase Agreement with CartiHeal, signaling its intent to move forward with an acquisition of CartiHeal. The Company’s decision came following its review of a statistical analysis report of the pivotal clinical trial of the Agili™-C implant, reimbursement coding analysis and significant market diligence including surgeon interviews with respect to Agili-C’s commercialization opportunity and ultimate market potential.
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 may only be exercised following FDA premarket approval (PMA) of the Agili-C implant, which was granted Breakthrough Device Designation by FDA last year, and the satisfaction of certain other conditions pursuant to the Option Agreement. Following the exercise of such option rights, the closing of the Potential Transaction is subject to certain customary conditions to closing. CartiHeal plans to submit the clinical module of their PMA later this year.
In the next several quarters, Bioventus plans to continue to work closely with the CartiHeal team in advance of potential FDA approval to be ready to execute on commercialization and reimbursement activities should the Potential Transaction be consummated.