ACL Reconstruction Startup Secures Funding to Support IDE Clinical Trial

Seeking a viable alternative to traditional anterior cruciate ligament (ACL) reconstruction, Martha Murray, M.D., pioneered Bridge-Enhanced® ACL Repair technology (BEAR), a proprietary bio-engineered sponge used as a bridging scaffold to stimulate healing of a torn ACL. Last week, Murray’s company, MIACH Orthopaedics, closed an important $22.5MM round of Series A funding to support accelerated manufacturing and continued Investigational Device Exemption (IDE) clinical trials in preparation for future pursuit of Premarket Approval (PMA) from FDA.

The funding round was co-led by Amzak Health Investors and DSM Venturing, with participation from, notably, the NFL Players Association (NFLPA) as well as additional investors. Initial research funding was provided by NFLPA, the National Institutes of Health and Boston Children’s Hospital. Dr. Murray is a sports medicine surgeon at Boston Children’s Hospital and a professor at Harvard Medical School.

MIACH Orthopaedics was founded in 2016 to develop implants like BEAR for connective tissue repair. Unlike traditional ACL reconstruction, the BEAR procedure does not require taking grafts from healthy parts of the leg. The BEAR implant—comprising extracellular matrix proteins and collagen—is placed arthroscopically using stitches and then injected with the patient’s blood, which clots in the implant and holds the ACL in place long enough for it to heal.

According to MIACH, preclinical studies suggest that knees treated with BEAR have a significantly lower rate of arthritis than those treated with traditional ACL reconstruction. The company has initiated an IDE clinical trial using ~100 human patients to generate sufficient data for a PMA.

The BEAR I and BEAR II clinical trials are underway at Boston Children’s; 75 patients have received the implant. BEAR I patients are two to three years out and BEAR II patients are one year out.

The pivotal BEAR III trial is in enrollment stages.

 

Rob Meyer is ORTHOWORLD’s Senior Editor. Please send comments on this article to Carolyn LaWell.

 

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