FDA Updates Label for Reduced Osteoarthritis Risk With BEAR Implant Over ACL Reconstruction

The United States (US) Food and Drug Administration (FDA) has granted 510(k) clearance to update labeling of Miach Orthopedics’ BEAR (Bridge-Enhanced ACL Restoration) implant to include a reduced risk of developing radiographically confirmed post-traumatic osteoarthritis (PTOA) compared to ACL reconstruction using hamstring tendon autograft after an ACL injury, making the implant the first sports medicine product to include such a label.¹

“For decades, we’ve focused on restoring knee stability with ACL reconstruction, while largely accepting post-traumatic osteoarthritis as an unavoidable future tradeoff,” Gregory DiFelice, MD, strategic advisor for Miach Orthopaedics, said in a statement.¹ “The simple reason is because there were never other reasonable options to stabilize the knee following an ACL tear beyond reconstruction. Until now. Data from the BEAR I and II studies clearly demonstrate that patients 14 and older treated with an ACL reconstruction are significantly more likely to develop post-traumatic osteoarthritis than those undergoing a BEAR Implant procedure. The risk of post-traumatic arthritis should be part of every ACL treatment discussion so that patients and parents can understand how different surgical treatment options impact the long-term health of the knee, not just short-term recovery."

The FDA approved the updated label based off of 6-year pooled data from the BEAR I and BEAR II studies, which evaluated rates of radiographically confirmed PTOA following the BEAR procedure versus ACL reconstruction. The trials included patients aged 14 years and older with ACL tears and concomitant baseline knee injuries, such as meniscal tears, and primarily compared outcomes with ACLR using hamstring autograft. Across the pooled analysis, patients treated with ACLR experienced a PTOA rate six times higher than those treated with the BEAR Implant, with a statistically significant absolute reduction in 6-year PTOA of –27.7% for BEAR compared with ACLR (P = .002).¹

More recently, a systematic review and random-effects meta-analysis in accordance with PRISMA 2020 guidelines of 261 studies, with 14 undergoing full-text review after initial screening and 5 randomized clinical trials meeting inclusion criteria, found that at 12 months, BEAR demonstrated a large effect size (Cohen’s d = 3.14) comparable to BPTB reconstruction (Cohen’s d = 2.68), with no statistically significant difference between groups, although BEAR showed greater clinical significance with an effect size difference of 0.48. At 24 months, outcomes remained similar, with no clinical or statistical differences observed between BEAR (Cohen’s d = 3.56) and BPTB (Cohen’s d = 3.39). Overall, both approaches were associated with comparable IKDC scores at 12 and 24 months following ACL injury.²

PTOA is a progressive degenerative joint disease that can develop in the years following ACL injury, with prior studies reporting rates of clinically symptomatic PTOA as high as 50% among patients undergoing ACL reconstruction. Early manifestations may include knee pain, stiffness, swelling, and functional limitations, which can worsen over time and interfere with both daily activities and athletic participation. Currently, there is no disease-modifying therapy for PTOA, and management strategies are largely limited to symptom control, with total knee replacement remaining the only definitive treatment option.¹

The BEAR Implant is a proprietary, collagen-based device designed to facilitate biologic healing of a torn ACL. It is the first medical technology supported by Level 1 clinical evidence to demonstrate that the body can heal its own ACL. Unlike standard ACL reconstruction, the BEAR procedure does not require harvesting a healthy tendon from another site or the use of donor tissue. During the minimally invasive procedure, a small amount of the patient’s own blood is injected into the implant, which is then secured between the torn ends of the ACL to act as a scaffold for healing. As the ligament heals and reattaches to the femur and tibia, the implant is gradually resorbed by the body.¹

“Pre-clinical BEAR Implant research suggested that preserving the native ACL could reduce the risk of post-traumatic osteoarthritis. This label update is a validation of the long-term clinical data displaying an unprecedented benefit in a FDA cleared claim, setting a new bar for what patients and clinicians should expect from ACL treatment and reinforcing the potential for the BEAR Implant to change the trajectory of knee health after ACL injury,” Patrick McBrayer, president and CEO of Miach Orthopaedics, added.¹

References

1. FDA Approves Updated Label for Miach Orthopaedics’ BEAR® Implant to Include Significantly Lower Risk of Osteoarthritis. News release. FDA. January 15, 2026. https://www.biospace.com/press-releases/fda-approves-updated-label-for-miach-orthopaedics-bear-implant-to-include-significantly-lower-risk-of-osteoarthritis

2. Shah KP, Gelatt T, Kunal Damaraju, et al. Bridge Enhanced ACL Repair (BEAR) versus Bone Patella Tendon Bone (BPTB) ACL reconstruction among young athletes: A systematic review and meta-analysis. Journal of Orthopaedics. 2025;73:30-41. doi: 10.1016/j.jor.2025.12.008