Medical Professionals

BEAR^® Implant

The Bridge-Enhanced^® ACL Repair (BEAR^®) implant is a proprietary bio-engineered bridging scaffold to facilitate healing of the torn ACL.

The BEAR implant is designed to be surgically placed between the torn ACL ends at the time of repair, and to hold a small amount of the patient’s blood in the wound site. The combination of the BEAR implant and the patient’s blood provides a scaffold that allows the torn ends of the ACL to heal back together.

Illustration of the BEAR® implant process. Figure 1: Torn ACL. Figure 2: Place BEAR® implant between torn ACL ends. Add blood. Figure 3: Pull torn ACL ends into implant with stitches. Figure 4: Healing ACL tissue replaces BEAR® implant.

It is hoped this new technology will restore more normal anatomy and function of the knee, and thus enable a higher percentage of patients to get back to activities they enjoy.

The BEAR implant is an investigational device and is only available in FDA-approved clinical trials.

Watch this video to find out more about how the BEAR implant works.

Watch this video to find out more about ACL tears, the BEAR implant and the first patient to receive it.

BEAR Clinical Trials

Several clinical trials are underway to study the BEAR implant and its safety and efficacy.

BEAR I: Enrollment is completed in this single-center, non-randomized, two-arm study that compared 10 patients treated with the BEAR implant to 10 patients treated with hamstring autograft ACL reconstruction.
BEAR II: Enrollment is completed in this single-center, non-randomized, two-arm study that compared 65 patients treated with the BEAR implant to 35 patients treated with autograft ACL reconstruction.
BEAR III: Multi-center, prospective cohort clinical study designed to evaluate patient outcomes with the use of Miach's bridge-enhanced ACL repair technology for ACL ruptures.
BEAR MOON: Enrollment of 200 patients will begin later in 2019 in this randomized, controlled trial being conducted by Cleveland Clinic at five centers of excellence. The trial will compare patients treated with the BEAR implant to standard autograft patellar tendon reconstruction. The BEAR MOON trial is supported by a $6 million RO1 grant from the National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institutes of Health. For more information about the trial refer to https://clinicaltrials.gov/ct2/show/NCT03776162?term=BEAR+MOON&rank=1

Publications

Clinical Study Results

American Journal of Sports Medicine: "Predictors of Healing Ligament Size and Magnetic Resonance Signal Intensity at 6 Months After Bridge-Enhanced Anterior Cruciate Ligament Repair." April 2019
https://journals.sagepub.com/doi/abs/10.1177/0363546519836087?journalCode=ajsb

Orthopedic Journal of Sports Medicine: "Bridge-Enhanced Anterior Cruciate Ligament Repair: Two-Year Results of a First-in-Human Study." March 2019
https://journals.sagepub.com/doi/10.1177/2325967118824356

Journal of Orthopaedic Research: "Bench-to-Bedside: Bridge-Enhanced Anterior Cruciate Ligament Repair." July 2017
https://onlinelibrary.wiley.com/doi/full/10.1002/jor.23632

Orthopedic Journal of Sports Medicine: “The Bridge-Enhanced Anterior Cruciate Ligament Repair (BEAR) Procedure: An Early Feasibility Cohort Study.” November 2016
https://journals.sagepub.com/doi/10.1177/2325967116672176

Preclinical Study Results