NIH-Sponsored Study Compares BEAR Implant to ACL Reconstruction for Complete ACL Tears

Miach Orthopaedics, Inc., a company transforming the treatment of anterior cruciate ligament (ACL) tears, today announced that the BEAR MOON study comparing the BEAR® Implant to autograft bone-patellar tendon-bone (BPTB) ACL reconstruction (ACLR) has completed enrollment.

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

“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., principal investigator of the study, 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 of excellence. The study enrolled 150 patients between 18 and 55 years of age with complete ACL tears who were randomized during surgery to treatment with either the BEAR Implant or BPTB ACLR.³

“Our significant body of clinical evidence for the BEAR Implant, extending out 10 years, has shown consistently positive results,” said Patrick McBrayer, president and CEO, Miach Orthopaedics. “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 orthopaedic 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)” (NCT03776162) is supported by a $6 million R01 grant from the National Institute of Arthritis and Musculoskeletal and Skin Diseases of the NIH (Award Number R01AR074131) 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 the following sites:

• Brown University/Rhode Island Hospital (Providence, Rhode Island)
• Cleveland Clinic (Cleveland, Ohio)
• The Ohio State University (Columbus, Ohio)
• TRIA Orthopaedics Center/University of Minnesota (Bloomington, Minnesota)
• University of Colorado (Boulder, Colorado)
• Vanderbilt University (Nashville, Tennessee)

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

About The BEAR® Implant

The BEAR (Bridge-Enhanced ACL Restoration) Implant is a proprietary collagen-based implant used to facilitate healing of the torn ACL. The BEAR Implant is the first medical technology to demonstrate, with Level 1 clinical evidence, that it enables the body to heal its own 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 the use of a donor tendon. The BEAR Implant acts as a bridge to help ends of the torn ACL heal together. The surgeon injects a small amount of the patient’s own blood into the implant and attaches 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 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 rupture of the ACL, 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. Visit miachortho.com for complete product information, including Instructions for Use.

About Miach Orthopaedics, Inc.

Miach Orthopaedics, Inc., is a privately held company located in Westborough, Massachusetts, dedicated to developing surgical implants to facilitate connective tissue restoration. The company’s initial focus is the BEAR® Implant, which represents a paradigm shift in the treatment of ACL tears. For more information on Miach Orthopaedics and its products, visit www.miachortho.com and follow the company on Facebook, Instagram, TikTok and LinkedIn.

BEAR® Implant is a registered trademark of Miach Orthopaedics.

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