Miach Orthopaedics has completed the enrolment for the BEAR MOON study, which compares the collagen-based BEAR [Bridge-Enhanced ACL Restoration] Implant against autograft bone-patellar tendon-bone (BPTB) anterior cruciate ligament reconstruction (ACLR).
The randomised, controlled clinical trial will assess the implant鈥檚 potential in healing torn ACLs and naturally restoring knee function.
It is sponsored by the National Institutes of Health (NIH), spearheaded by the Cleveland Clinic and is carried out as part of the Multicenter Orthopaedic Outcomes Network (MOON) Group.
The trial enrolled 150 subjects aged between 18 and 55 years with complete ACL tears, who were randomised during surgery to receive either the implant or BPTB ACLR.
Supported by a $6m R01 grant from the NIH’s National Institute of Arthritis and Musculoskeletal and Skin Diseases, the study will assess patient results at six months, one year, and two years post-surgery.
Upon reaching the two-year mark, the company noted that the findings would be submitted for presentation and publication.
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By GlobalDataMiach Orthopaedics CEO and president Patrick McBrayer said: 鈥淥ur significant body of clinical evidence for the BEAR Implant, extending out ten years, has shown consistently positive results.
鈥淏y comparing the BEAR Implant to the standard of care ACLR, the BEAR MOON study provides the opportunity to build on these results in a multi-centre study at six of the leading orthopaedic institutions in the US.鈥�
The BEAR Implant does not necessitate a second surgical wound site to harvest a healthy tendon or the use of a donor tendon.
Combined with the patient’s blood, it facilitates the healing of the torn ACL ends, maintaining the original attachments of ACL to the femur and tibia, and is eventually resorbed by the body.
In March 2025, the US Food and Drug Administration cleared Miach Orthopaedics鈥� BEAR implant for expanded use to treat complete and partial ACL tears in children and adults of all ages.
