Globe Newswire08.30.21
Bioventus Inc., a global leader in innovations for active healing, has elected to make a $50 million escrow payment pursuant to its Option and Equity Purchase Agreement with CartiHeal Ltd., signaling its intent to move forward with an acquisition of CartiHeal. The ompany’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 option may only be exercised following premarket approval (PMA) by the U.S. Food and Drug Administration (FDA) of the Agili-C implant, which was granted Breakthrough Device Designation by the 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.
Agili-C is indicated for the treatment of a cartilage and osteochondral defects (defined as ICRS grade III or above) in the knee joint, in patients without severe osteoarthritis (Kellgren-Lawrence (KOOS) grade 0-3). The implant is designed to provide a cost effective solution in patients indicated for Agili-C.
“The 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,” said Alessandra Pavesio, senior vice president and chief science officer, Bioventus. “In combination with our HA products, Agili-C represents an exciting potential new offering for our portfolio designed to address the spectrum of osteoarthritis disease.”
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.
Bioventus delivers products that help people heal quickly and safely. Its mission is to make a difference by helping patients resume and enjoy active lives. The Innovations for Active Healing from Bioventus include offerings for pain treatment & joint preservation, restorative therapies and bone graft substitutes. Built on a commitment to high quality standards, evidence-based medicine and strong ethical behavior, Bioventus is a trusted partner for physicians worldwide.
The option may only be exercised following premarket approval (PMA) by the U.S. Food and Drug Administration (FDA) of the Agili-C implant, which was granted Breakthrough Device Designation by the 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.
Agili-C is indicated for the treatment of a cartilage and osteochondral defects (defined as ICRS grade III or above) in the knee joint, in patients without severe osteoarthritis (Kellgren-Lawrence (KOOS) grade 0-3). The implant is designed to provide a cost effective solution in patients indicated for Agili-C.
“The 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,” said Alessandra Pavesio, senior vice president and chief science officer, Bioventus. “In combination with our HA products, Agili-C represents an exciting potential new offering for our portfolio designed to address the spectrum of osteoarthritis disease.”
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.
Bioventus delivers products that help people heal quickly and safely. Its mission is to make a difference by helping patients resume and enjoy active lives. The Innovations for Active Healing from Bioventus include offerings for pain treatment & joint preservation, restorative therapies and bone graft substitutes. Built on a commitment to high quality standards, evidence-based medicine and strong ethical behavior, Bioventus is a trusted partner for physicians worldwide.
