BEAR Necessities Blog

The BEAR® Implant: 30+ Years of Innovation

Patients often ask surgeons if the BEAR® Implant is new. Though it was approved by the U.S. Food and Drug Administration (FDA) in 2020, it’s not as new as you might think. Read on for a brief history of the science and development of the BEAR Implant.

First Things First: Why Don’t ACLs Heal?

In 1989, Dr. Martha Murray, founder of Miach Orthopaedics and professor of orthopedic surgery at Boston Children’s Hospital and Harvard Medical School, began research at Stanford University into whether patient outcomes could be improved by encouraging the anterior cruciate ligament (ACL) to heal, rather than replacing it during traditional ACL surgery, called ACL reconstruction (ACLR).

By comparing knee ligaments that do heal (like the MCL, or medial collateral ligament) to ligaments that don’t heal (like the ACL), Dr. Murray found a key difference: When the MCL is torn, a blood clot forms between the torn tissue ends and serves as a bridge for the tissue to heal back into. When the ACL tears, clot formation is prohibited by a thick liquid in the knee joint – called synovial fluid – that normally reduces friction between the bones when you move. After more than a decade of research, in 2000 Dr. Murray and her team discovered that blood clots were a crucial contributor to creating an environment for ACL healing.

Bridging the Gap with the BEAR Implant   

Armed with this new information on why ACLs can’t heal on their own, Dr. Murray and her team designed a collagen-platelet implant to serve as a bridge to hold and protect the blood in the gap between the torn ACL ends. This allowed the formation of blood clots necessary for healing. In 2009, the first preclinical study was published in the American Journal of Sports Medicine. The team continued to refine and improve the implant, and eventually it became the Bridge-Enhanced® ACL Restoration (BEAR®) Implant. In 2013, preclinical results were published in the American Journal of Sports Medicine, demonstrating that use of the BEAR Implant stimulated ACL healing.

Proving ACL Healing in Humans is Possible  

After obtaining approval from the FDA to conduct clinical trials in humans, in 2015, Corey Peak became the first person to get the BEAR Implant as part of the BEAR I feasibility clinical study. BEAR I assessed the safety and early efficacy of the BEAR Implant to repair an ACL in comparison to ACLR – the current standard of care. In 2016, BEAR I study results were published in the Orthopedic Journal of Sports Medicine, demonstrating patients treated with the BEAR Implant had similar clinical, functional and patient-reported outcomes to ACLR. These findings were further supported by the publication of BEAR II pivotal study results in the American Journal of Sports Medicine, which showed that after two years, patients who received the BEAR Implant had similar ACL healing outcomes and superior hamstring muscle strength in comparison to ACLR.

Making History

Supported by these positive clinical trial results, the BEAR Implant received FDA approval in 2020, becoming the first and only medical technology to enable the ACL to heal on its own. This new approach was a paradigm shift from ACLR, and it was also the first significant advancement in the treatment of ACL tears in more than 30 years. In 2021, the BEAR Implant was officially launched in the U.S.

Recognizing Innovation

As the BEAR Implant procedure started to gain momentum at multiple sites throughout the country, it was awarded a Popular Science Best of What’s New Award in 2021 for representing a significant step forward in health. Its unique technology has since continued to be recognized by the orthopedic industry. Dr. Murray’s research on ACL healing was selected for the Orthopaedic Research and Education Foundation (OREF) Clinical Research Award in 2022 and Miach Orthopaedics received the ACE Award for cutting-edge innovation in sports medicine from the American Orthopaedic Society for Sports Medicine in 2023.

Healing ACLs One Patient at a Time

As of October 2023, more than 2,000 patients have been treated with the BEAR Implant commercially and as part of the completed and ongoing clinical studies. Miach Orthopaedics is continuing to collect data on the implant through post-market and label expansion studies – BEAR III and BEAR-MOON – as well as the Bridge Registry study.

Understanding how the ACL works and how to facilitate its healing has come a long way in the last 30 years. Although the BEAR Implant may seem new, three decades of research and development led to it being approved by the FDA as the only implant clinically proven to enable your body to heal its own ACL.

Learn more about the BEAR Implant and find a surgeon

The BEAR Implant is available across the U.S. Learn more about the BEAR Implant or find a surgeon in your area.

The BEAR Implant from Miach Orthopaedics was approved by the U.S. Food and Drug Administration in December 2020. It is indicated for skeletally mature patients at least 14 years of age with a complete rupture of the ACL confirmed by MRI. Patients must have an ACL stump attached to the tibia to facilitate the restoration.

It is important to follow the BEAR Implant physical therapy program. Your surgeon can explain the program details.

Be sure to discuss your individual symptoms, diagnosis and treatment with your surgeon. The BEAR Implant has the same potential medical/surgical complications as other orthopedic surgical procedures, including ACL reconstruction. These include the risk of re-tear, infection, knee pain, meniscus injury and limited range of motion.

Visit www.miachortho.com for complete product information, including Instructions for Use.

ML-1124 Rev A 11/2023