Miach Orthopaedics, a company revolutionizing ACL tear treatment, has announced that the U.S. Food and Drug Administration has granted clearance for updated labeling of its BEAR (Bridge-Enhanced ACL Restoration) Implant. 

 

The new label highlights a reduced risk of developing radiographically confirmed post-traumatic osteoarthritis (PTOA) after ACL injury, compared with traditional ACL reconstruction using hamstring tendon autograft. The BEAR Implant is the first sports medicine device to carry a label claim related to lowering PTOA risk.

 

PTOA is a progressive joint disease that can emerge years after an ACL injury, with studies showing rates of clinically symptomatic PTOA as high as 50% in patients who undergo ACL reconstruction. Early symptoms include knee pain, stiffness, swelling, and loss of function, which can worsen over time and disrupt daily life and athletic activity. 

 

Currently, there is no cure other than total knee replacement, and treatment focuses on symptom management rather than joint restoration.

 

“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, 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 FDA label update reflects six-year pooled data from the BEAR I and II studies, which compared rates of radiographically confirmed PTOA in patients ages 14 and older treated with the BEAR Implant versus ACL reconstruction (primarily using hamstring autograft), including those with additional knee injuries such as meniscus tears. 

 

Results showed that patients treated with ACL reconstruction were six times more likely to develop PTOA than those treated with the BEAR Implant. The six-year reduction in PTOA for BEAR patients was statistically significant at –27.7%, underscoring the importance of long-term knee health as a key outcome in ACL surgery.

 

“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.”