WESTBOROUGH, Massachusetts – January 14, 2026 – Miach Orthopaedics, Inc., a company transforming the treatment of anterior cruciate ligament (ACL) tears, today announced that the U.S. Food and Drug Administration has granted 510(k) clearance for updated labeling of the BEAR® (Bridge-Enhanced ACL Restoration) Implant to include a reduced risk of developing radiographically confirmed post-traumatic osteoarthritis (PTOA) following ACL injury compared to ACL reconstruction using hamstring tendon autograft. The BEAR Implant is the first sports medicine product to include a label claim related to reduced PTOA risk.
PTOA is a progressive joint disease that can develop during the years after an ACL injury, with studies showing rates of clinically symptomatic PTOA as high as 50% for patients who undergo ACL reconstruction. Early symptoms may include knee pain, stiffness, swelling, or loss of function, which can worsen over time and interfere with daily activities and athletic participation. There is currently no cure for PTOA, other than total knee replacement, and available treatments focus on managing symptoms rather than restoring joint health.
“For decades, we’ve focused on restoring knee stability with ACL reconstruction, while largely accepting post-traumatic osteoarthritis as an unavoidable future tradeoff,” said Gregory DiFelice, MD, strategic advisor for Miach Orthopaedics. “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 label update was based on six-year pooled data from the BEAR I and BEAR II studies, which assessed the rate of radiographically confirmed PTOA following the BEAR procedure compared with ACL reconstruction (using mainly hamstring autograft) in patients ages 14 and older with concomitant baseline knee injuries, such as a meniscus tear. Patients treated with ACL reconstruction had a rate of PTOA six times higher than patients treated with the BEAR Implant. The reduction in six-year PTOA for BEAR Implant patients compared to ACLR was statistically significant (–27.7%, p=0.002), reinforcing long-term knee health as an important outcome for ACL surgery beyond short-term stability and return to play.
“Today is a defining moment in ACL tear treatment,” said Patrick McBrayer, president and CEO of Miach Orthopaedics. “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.”
About The BEAR® Implant
The BEAR (Bridge-Enhanced ACL Restoration) Implant is a proprietary collagen-based implant used to facilitate healing of the torn ACL. The BEAR Implant is the first medical technology to demonstrate, with Level 1 clinical evidence, that it enables the body to heal its own torn ACL. Unlike reconstruction, which is the current standard of care, the BEAR Implant does not require a second surgical wound site to remove a healthy tendon from another part of the leg or the use of a donor tendon. The BEAR Implant acts as a bridge to help ends of the torn ACL heal together. The surgeon injects a small amount of the patient’s own blood into the implant and attaches it between the torn ends of the ACL in a minimally invasive procedure. The combination of the BEAR Implant and the patient’s blood enables the body to heal the torn ends of the ACL back together while maintaining the ACL’s original attachments to the femur and tibia. As the ACL heals, the BEAR Implant is resorbed by the body.
In patients 14 years and older who have an ACL injury with concomitant knee injuries, ACL restoration with the BEAR Implant reduces the risk of developing post-traumatic knee osteoarthritis (Kellgren-Lawrence grade 2 or higher), at 6-years post-surgery, compared to ACL reconstruction (ACLR) surgery using hamstring tendon autograft.
The BEAR Implant was first granted De Novo Approval from the U.S. Food and Drug Administration in December 2020. It is indicated for adults, adolescents and children with a complete or partial rupture of the ACL, as confirmed by MRI. Patients must have an ACL stump attached to the tibia to construct the repair. Children with open physes must have sufficient bone in the femoral and tibial epiphyses on either side of the intended tunnel locations to avoid disruption of the growth plates. Visit miachortho.com for complete product information, including Instructions for Use.
About Miach Orthopaedics, Inc.
Miach Orthopaedics, Inc., is a privately held company located in Westborough, Massachusetts, dedicated to developing surgical implants to facilitate connective tissue restoration. The company’s initial focus is the BEAR® Implant, which represents a paradigm shift in the treatment of ACL tears. For more information on Miach Orthopaedics and its products, visit www.miachortho.com
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BEAR® Implant is a registered trademark of Miach Orthopaedics.
