WESTBOROUGH, Mass. — Miach Orthopaedics said the U.S. Food and Drug Administration has granted 510(k) clearance for updated labeling of its BEAR (Bridge-Enhanced ACL Restoration) Implant to include a reduced risk of developing post-traumatic osteoarthritis following an anterior cruciate ligament injury, compared with traditional ACL reconstruction using a hamstring tendon autograft.
The company said the BEAR Implant is the first sports medicine product to carry an FDA-cleared label claim related to a reduced risk of post-traumatic osteoarthritis, a progressive joint disease that can emerge years after an ACL injury and often worsens over time.
The label update is based on six-year pooled data from the BEAR I and BEAR II clinical studies, which evaluated patients ages 14 and older who had ACL injuries along with baseline knee damage such as meniscus tears. According to the studies, patients treated with ACL reconstruction experienced a rate of radiographically confirmed post-traumatic osteoarthritis that was six times higher than those treated with the BEAR Implant. The reduction in osteoarthritis risk among BEAR patients compared with ACL reconstruction was statistically significant, at –27.7 percent, with a p-value of 0.002.
Post-traumatic osteoarthritis can cause knee pain, stiffness, swelling, and loss of function, potentially limiting daily activity and athletic participation. Studies have shown that clinically symptomatic osteoarthritis can develop in up to half of patients who undergo ACL reconstruction. There is no cure for the condition other than total knee replacement, and existing therapies focus on symptom management 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, M.D., a 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.”
Miach said earlier pre-clinical research suggested that preserving the native ACL could reduce the likelihood of developing osteoarthritis after injury, a hypothesis the company said is now supported by long-term clinical data.
“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.”
