BEAR Implant's Updated FDA Label Reflects Reduced Osteoarthritis Risk, With Gregory DiFelice, MD

The Bridge-Enhanced ACL Restoration (BEAR) Implant now carries FDA-cleared labeling indicating a reduced risk of radiographically confirmed post-traumatic osteoarthritis (PTOA) compared with ACL reconstruction using hamstring tendon autograft — a development that Gregory S. DiFelice, MD, argues should reframe how clinicians approach the ACL treatment conversation.

In a conversation with RheumatologyLive, DiFelice, an attending orthopedic surgeon specializing in sports traumatology and joint reconstruction at Hospital for Special Surgery and a strategic advisor for BEAR Implant manufacturer Miach Orthopaedics, explained that the impetus for the device goes back to a fundamental limitation of the synovial joint environment. When the ACL tears, the fluid-filled knee joint washes away the blood clot and associated healing factors before the ligament ends can consolidate, a failure mode that has no analog in extraarticular fractures where clot stability drives natural repair. The BEAR Implant — a bovine collagen scaffold roughly the size of a thumb — is introduced arthroscopically to occupy the space around the torn ligament, physically retaining the clot and creating what DiFelice described as a biological scaffold that allows native healing to proceed.

The FDA granted 510(k) clearance for the updated label on January 14, 2026, based on data from the BEAR I and BEAR II studies. In patients aged 14 years and older with ACL injury and concomitant knee pathology, the BEAR procedure was associated with a significantly lower rate of developing PTOA — defined as Kellgren-Lawrence grade 2 or higher — at 6 years postoperatively versus hamstring tendon autograft reconstruction. Across those studies, ACL reconstruction was associated with a 6-fold higher rate of radiographically confirmed PTOA compared with the BEAR Implant. Rates of clinically symptomatic PTOA following ACL reconstruction have been reported as high as 50% in the broader literature. The BEAR Implant is indicated for complete or partial ACL rupture confirmed by MRI, with the requirement that an ACL stump remain attached to the tibia; it received its original De Novo approval from the FDA in December 2020.

DiFelice noted that prior attempts at ACL repair in the 1970s and 1980s failed not because the concept was flawed but because the technique — open surgery followed by casting — produced unacceptable stiffness and inconsistent results, leading the field to abandon repair in favor of reconstruction. The BEAR Implant represents a departure from that historical failure by addressing the root biological obstacle rather than defaulting to graft replacement.

“When we do a modern day repair to the ACL, the BEAR implant can be slipped inside the knee so that it fills up the area around the ligament, and it holds the clot in place, so that it helps it to heal. In essence, it almost makes a almost like a blood blanket that sits on the ACL and holds the healing factors in place, so that the nature can take over in the biology can kick in and get the ends of the ligaments to knit,” DiFelice said.

DiFelice’s reported disclosures include Miach Orthopedics.

Reference

Miach Orthopaedics, Inc. FDA approves updated label for Miach Orthopaedics' BEAR® Implant to include significantly lower risk of osteoarthritis. Business Wire. January 14, 2026. Accessed [date]. https://www.businesswire.com/news/home/20260114688148/en/FDA-Approves-Updated-Label-for-Miach-Orthopaedics-BEAR-Implant-to-Include-Significantly-Lower-Risk-of-Osteoarthritis