Enrollment Complete in BEAR Implant Study

The BEAR MOON study comparing Miach Orthopaedics Inc.’s BEAR Implant to autograft bone-patellar tendon-bone (BPTB) anterior cruciate ligament reconstruction (ACLR) has completed enrollment. 

The National Institutes of Health (NIH)-sponsored study—led by the Cleveland Clinic and conducted as part of the Multicenter Orthopaedic Outcomes Network (MOON) Group—will add to the clinical evidence evaluating the BEAR Implant’s ability to heal a torn ACL and restore the knee’s natural function.

“The current standard of care for ACL reconstruction involves using a graft from the patient’s hamstring or patellar tendon to replace the ACL,” said Kurt Spindler, M.D., study principal investigator and associate chief, Clinical Research, at The Cleveland Clinic. “Previous BEAR Implant studies compared the BEAR Implant to the hamstring autograft. BEAR MOON will add important clinical insights on the effectiveness of the BEAR Implant compared to BPTB, which is one of the most widely used grafts in ACL reconstruction.”^1,2

BEAR MOON is a randomized, controlled clinical trial led by the Cleveland Clinic and conducted at six clinical centers. The study enrolled 150 patients between 18 and 55 years old with complete ACL tears who were randomized during surgery to treatment with either the BEAR Implant or Bone-Patellar Tendon-Bone (BPTB) ACLR.³

“Our body of clinical evidence for the BEAR Implant, extending out 10 years, has shown consistently positive results,” Miach Orthopaedics President/CEO Patrick McBrayer said. “By comparing the BEAR Implant to standard of care ACLR, the BEAR MOON study provides the opportunity to build on these results in a multi-center study at six of the leading orthopedic institutions in the U.S. We would like to thank the BEAR MOON investigators and clinical study site teams for their commitment to this study since 2018, and we look forward to the results and the impact they may have on the field of sports medicine.”

“A Comparison of ACL Repair With BEAR Device vs. Autograft Patellar Tendon ACL Reconstruction (BEAR-MOON)” is funded by a $6 million R01 grant from the National Institute of Arthritis and Musculoskeletal and Skin Diseases of the NIH and is being conducted as part of the MOON Group. BEAR Implants were purchased from Miach Orthopaedics. Patients have been enrolled, and their follow-up continues at Brown University/Rhode Island Hospital (Providence, R.I.); Cleveland Clinic (Cleveland, Ohio); The Ohio State University (Columbus, Ohio); TRIA Orthopaedics Center/University of Minnesota (Bloomington, Minn.); University of Colorado (Boulder, Colo.); and Vanderbilt University (Nashville, Tenn.). 

The study will evaluate outcomes at six months, one year ,and two years after surgery. After completing the two-year milestone, study results will be submitted for presentation and publication. 

The BEAR (Bridge-Enhanced ACL Restoration) Implant is a proprietary collagen-based implant used to facilitate torn ACL healing. The BEAR Implant is the first medical technology to show with Level 1 clinical evidence that it enables the body to heal its own torn ACL. Unlike reconstruction—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 the use of a donor tendon. The BEAR Implant acts as a bridge to help the torn ACL ends heal together. The surgeon injects a small amount of the patient’s own blood into the implant and attaches it between the ACL’s torn ends in a minimally invasive procedure. The combination of the BEAR Implant and the patient’s blood enables the body to heal the ACL’s torn ends while maintaining the ACL’s original femur and tibia attachments. As the ACL heals, the BEAR Implant is resorbed by the body.

The BEAR Implant was first granted De Novo Approval from the U.S. Food and Drug Administration in December 2020. It is indicated for adults, adolescents, and children with a complete or partial ACL rupture as confirmed by MRI. Patients must have an ACL stump attached to the tibia to construct the repair. Children with open physes must have sufficient bone in the femoral and tibial epiphyses on either side of the intended tunnel locations to avoid disruption of the growth plates. 

Miach Orthopaedics Inc. is a privately held company located in Westborough, Mass., developing surgical implants to facilitate connective tissue restoration. The company’s initial focus is the BEAR Implant.

References
¹ Murray MM, Kalish LA, Fleming BC, et al. Bridge-Enhanced Anterior Cruciate Ligament Repair: Two-Year Results of a First-in-Human Study. Orthopaedic Journal of Sports Medicine. 2019;7(3). doi:10.1177/2325967118824356
² Murray MM, Fleming BC, Badger GJ, et al. 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. The American Journal of Sports Medicine. 2020;48(6):1305-1315. doi:10.1177/0363546520913532
³ Spindler KP, Imrey PB, et al. Design Features and Rationale of the BEAR-MOON (Bridge-Enhanced ACL Restoration Multicenter Orthopaedic Outcomes Network) Randomized Clinical Trial. Orthopaedic Journal of Sports Medicine. 2022;10(1). doi:10.1177/23259671211065447