Medical Professionals

The BEAR® Implant is not currently available in the U.S. or any other part of the world due to the COVID-19 pandemic. If you are a physician interested in being trained on the BEAR Implant, please complete this form and we will contact you when the BEAR Implant is available in your area.

BEAR® Implant

The Bridge-Enhanced® ACL Repair (BEAR®) Implant is a proprietary bio-engineered implant used to facilitate healing of the torn ACL. Unlike reconstruction, which is the current standard of care, the BEAR Implant does not require a second surgical wound site to remove a healthy tendon from another part of the leg or using a deceased donor’s tendon. The BEAR Implant acts as a bridge between the two ends of the torn ACL.

The surgeon injects a small amount of the patient’s own blood into the implant and inserts it between the torn ends of the ACL in a minimally invasive procedure. The combination of the BEAR Implant and the patient’s blood enables the body to heal the torn ends of the ACL back together while maintaining the ACL’s original attachments to the femur and tibia. As the ACL heals, the BEAR Implant is absorbed by the body, within approximately eight weeks.

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.

The proprietary, bio-engineered BEAR Implant facilitates healing of the torn ACL and has several benefits over ACL reconstruction: It restores natural anatomy and function of the knee, is less invasive and has better patient satisfaction in terms of readiness to return to sport and one-year pain and symptoms. The BEAR Implant does not require a second surgical wound site to remove a healthy tendon from another part of the leg or using a deceased donor’s tendon that requires special storage and handling requirements.

Listen to this podcast to hear about the development of the BEAR Implant and clinical trial results.

The BEAR Implant was cleared by the U.S. Food & Drug Administration through the De Novo Pathway in December 2020 for the following indication:

The BEAR® (Bridge-Enhanced ACL Repair) Implant is a bovine extracellular matrix collagen-based implant for treatment of anterior cruciate ligament (ACL) injuries. The BEAR® Implant is indicated for skeletally-mature patients at least 14 years of age with a complete rupture of the ACL, as confirmed by MRI. Patients must have an ACL stump attached to the tibia to construct the repair.

For full product and risk information, including indications, contraindications, warnings and potential adverse effects, see the Instructions for Use on this website.

Publications

The following are clinical studies that have been published to date regarding the BEAR Implant. For information on preclinical and development programs, click here.

Clinical Study Results

Higher Physiologic Platelet Counts in Whole Blood Are Not Associated With Improved ACL Cross-sectional Area or Signal Intensity 6 Months After Bridge-Enhanced ACL Repair
Orthopaedic Journal of Sports Medicine, July 2020

Females Have Earlier Muscle Strength and Functional Recovery After Bridge-Enhanced Anterior Cruciate Ligament Repair
Tissue Engineering Part A, June 25, 2020 (Ahead of Print)

Bridge-Enhanced Anterior Cruciate Ligament Repair Is Not Inferior to Autograft Anterior Cruciate Ligament Reconstruction at 2 Years: Results of a Prospective Randomized Clinical Trial
American Journal of Sports Medicine, May 2020

Changes in Cross-sectional Area and Signal Intensity of Healing Anterior Cruciate Ligaments and Grafts in the First 2 Years After Surgery
American Journal of Sports Medicine, June 2019

Predictors of Healing Ligament Size and Magnetic Resonance Signal Intensity at 6 Months After Bridge-Enhanced Anterior Cruciate Ligament Repair
American Journal of Sports Medicine, April 2019

Bridge-Enhanced Anterior Cruciate Ligament Repair: Two-Year Results of a First-in-Human Study
Orthopedic Journal of Sports Medicine, March 2019

Bench-to-Bedside: Bridge-Enhanced Anterior Cruciate Ligament Repair
Journal of Orthopaedic Research, July 2017

The Bridge-Enhanced Anterior Cruciate Ligament Repair (BEAR) Procedure: An Early Feasibility Cohort Study
Orthopedic Journal of Sports Medicine, November 2016

The articles referenced above may refer to the BEAR Implant as “the BEAR ACL scaffold,” “bioactive scaffold,” or “scaffold.” These developmental descriptions do not reflect the current name and descriptor of the device, which is the BEAR Implant.