FDA Approves Updated Label for BEAR Implant

FDA granted 510(k) clearance for updated labeling of Miach Orthopaedics’ 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 claimed to be the first sports medicine product to include a label claim related to reduced PTOA risk.

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, 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 an 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.”

Source: Miach Orthopaedics, Inc.