Miach Orthopaedics, a company advancing the treatment of Anterior Cruciate Ligament (ACL) tears, has announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance for updated labeling of its BEAR (Bridge-Enhanced ACL Restoration) Implant. The updated label includes a new claim demonstrating a reduced risk of developing radiographically confirmed Post-Traumatic Osteoarthritis (PTOA) following ACL injury, compared with ACL reconstruction using hamstring tendon autograft.

With this clearance, the BEAR Implant becomes the first sports medicine product to include an FDA-cleared label claim related to lowering the risk of PTOA—a progressive and debilitating joint disease that can develop years after an ACL injury. Studies show that up to 50 percent of patients who undergo traditional ACL reconstruction may develop clinically symptomatic PTOA, often leading to chronic pain, stiffness, swelling, reduced mobility and, in severe cases, total knee replacement.

Gregory DiFelice, MD, strategic advisor for Miach Orthopaedics. Said, “For decades, ACL treatment has focused primarily on restoring knee stability, while post-traumatic osteoarthritis was often seen as an unavoidable consequence. Data from the BEAR I and II studies clearly show that patients treated with ACL reconstruction are significantly more likely to develop PTOA than those undergoing the procedure. This risk should be a key part of every ACL treatment discussion, especially when considering long-term knee health.”

The FDA’s decision is based on six-year pooled data from the BEAR I and BEAR II clinical studies, which evaluated patients aged 14 years and older with ACL injuries and concomitant knee damage, such as meniscus tears. The data showed that patients treated with ACL reconstruction experienced PTOA at a rate six times higher than those treated with the BEAR Implant. The reduction in PTOA at six years for BEAR Implant patients compared to ACL reconstruction was significant.

Patrick McBrayer, President and CEO of Miach Orthopaedics, called the label update a milestone for sports medicine. He said, “This FDA-cleared claim validates years of clinical data showing that preserving the native ACL can meaningfully reduce the risk of post-traumatic osteoarthritis. It sets a new benchmark for what patients and clinicians should expect from ACL treatment and highlights the potential of the BEAR Implant to change the long-term trajectory of knee health.”

The Bear Implant is a proprietary, collagen-based medical device designed to enable the body to heal its own torn ACL. Unlike traditional ACL reconstruction, which requires harvesting a healthy tendon from another part of the leg or using donor tissue, the BEAR procedure preserves the native ligament. During the minimally invasive surgery, a small amount of the patient’s own blood is injected into the implant, which is then positioned between the torn ends of the ACL. The implant acts as a bridge, supporting natural healing while maintaining the ligament’s original attachments to the femur and tibia. As healing progresses, the implant is gradually resorbed by the body.