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.
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
- This study assessed whether concentrations of various blood cell types placed into the BEAR Implant at the time of ACL repair would have a significant effect on the healing ligament cross-sectional area or tissue organization (as measured by signal intensity). In 61 patients who underwent MRI at 6 months as part of the BEAR II trial, older age, male gender, and monocyte concentration in female patients were associated with greater healing ligament cross-sectional area; however, signal intensity of the healing ligament was independent of these factors. Physiologic platelet concentration did not have any significant effect on cross-sectional area or signal intensity of the healing ACL.
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)
- The first study comparing gender-specific outcomes for the BEAR Implant found no significant difference between males and females on patient-reported outcomes and objective anteroposterior (AP) laxity testing up to two years postoperatively, despite the fact that females had better hamstring and quadriceps strength indices at 6 months than males as well as better hop test results at 6 and 12 months.
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
- The study compared 65 patients treated with the BEAR Implant to 35 treated with autograft anterior cruciate ligament reconstruction (ACLR). The BEAR Implant resulted in non-inferior patient-reported outcomes and anteroposterior (AP) knee laxity, as well as superior hamstring strength, compared to ACLR in a young and active cohort at two-year follow-up.
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
- The study compared 10 patients treated with the BEAR Implant to 10 treated with traditional hamstring autografts, using the contralateral ACL as reference. Based on MRI imaging, ACLs treated with the BEAR implant had a cross-sectional area (quantity), signal intensity (quality) and sagittal orientation that were similar to the contralateral ACL at 12 months, whereas hamstring autografts were significantly larger and more vertically oriented than the native ACL at 24 months.
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
- The study evaluated 62 patients treated with the BEAR Implant using MRI imaging at six months. Modifiable factors, including surgical notchplasty and slower recovery of quadriceps strength at three months, were associated with a larger cross-sectional area and improved signal intensity of the healing ACL. Further studies are needed to determine the optimal size of the notchplasty and the most effective postoperative rehabilitation strategy after ACL repair.
Bridge-Enhanced Anterior Cruciate Ligament Repair: Two-Year Results of a First-in-Human Study
Orthopedic Journal of Sports Medicine, March 2019
- First-in-human study assessed the safety and early efficacy of the BEAR Implant to repair an ACL and compared 10 patients treated with the BEAR Implant to 10 treated with traditional hamstring autografts at 24 months. The BEAR Implant resulted in similar clinical, functional and patient-reported outcomes compared to patients undergoing autograft ACL reconstruction. In addition, the BEAR Implant did not result in any patients having an infection or a severe inflammatory reaction, arthrofibrosis or a reaction that required implant removal.
Bench-to-Bedside: Bridge-Enhanced Anterior Cruciate Ligament Repair
Journal of Orthopaedic Research, July 2017
- Review paper detailing the pathway of how a tissue engineering strategy can be used to improve the healing of the ACL in preclinical studies and then translated to patients in an FDA‐approved clinical study. Outlines clinical importance of ACL injuries, history of primary repair, pathology behind failure of the ACL to heal, pre‐clinical studies, FDA approval process, and preliminary results of the first‐in‐human study.
The Bridge-Enhanced Anterior Cruciate Ligament Repair (BEAR) Procedure: An Early Feasibility Cohort Study
Orthopedic Journal of Sports Medicine, November 2016
- First-in-human study compared 10 patients treated with the BEAR Implant to 10 treated with traditional hamstring autografts at three months. The BEAR Implant was tolerated by the synovial environment of the knee, with no deep infections or serious inflammatory reactions noted in the early postoperative period during which the implant is resorbed.