BEAR Implant Registry Data Demonstrate Low ACL Retear Rates 

Miach Orthopaedics Inc. is using the American Orthopaedic Society for Sports Medicine (AOSSM) Annual Meeting platform this week to release two-year outcomes from the first 200 BEAR Implant patients enrolled in the Bridge Registry.

The company is highlighting the ways evolved fixation and suture techniques have advanced the BEAR (Bridge-Enhanced ACL Restoration) procedure for treating anterior cruciate ligament (ACL) tears. Two-year outcomes for the 200-patient group are trending with the 100-patient group recently published in the Video Journal of Sports Medicine showing a 5% ACL retear rate.

“One of the most encouraging findings from the Bridge Registry is that refinements in BEAR Implant surgical technique can have a meaningful impact on patient outcomes,” said Dr. Jocelyn Wittstein, orthopedic surgeon at Duke University and co-investigator of the Bridge Registry study. “The modified techniques were associated with a lower overall reoperation rate than the original technique, with no difference in other safety outcomes, giving surgeons’ greater confidence as they incorporate the BEAR Implant into their clinical practice.”

Miach Orthopaedics is highlighting these techniques and additional findings at the OSSM Annual Meeting, as well as the growing body of evidence supporting ACL restoration:

• “Playing the ACL Long Game: Registry Outcomes and Reduction of Post-Traumatic Osteoarthritis with the BEAR Implant”; Speakers: Drs. Jay Albright, Jacqueline Brady and Wittstein.
• “The BEAR Implant Experience: Restoring ACLs the Natural Way”; Speaker: Dr. Brian Lau
• “ACL Preservation Evolved: Clinical Experience & Advanced Techniques with the BEAR Implant”; Speaker: Dr. Gregory DiFelice, Miach Strategic Advisor

“Nearly 10,000 patients have now been treated with the BEAR Implant, and the evidence continues to demonstrate what’s possible when surgeons preserve the native ACL,” Miach Orthopaedics President/CEO Jamal Rushdy stated. “We are committed to advancing ACL restoration through continued innovation in surgical technique and a growing understanding of the importance of long-term knee health so more surgeons can confidently make ACL restoration an integral part of their treatment algorithm.”

The Bridge Registry was initiated in May 2023 to assess real-world outcomes for the BEAR Implant. Primary outcomes being tracked include knee function and feeling measured by the International Knee Documentation Committee (IKDC) Subjective Knee Evaluation at two years and knee laxity measured with Lachman scoring at one year. A total of 300 patients were enrolled at nine sites: AdventHealth, Boston Children’s Hospital, Duke University, Hospital for Special Surgery, Oregon Health and Science University, Stanford University School of Medicine, Steamboat Orthopaedic & Spine Institute, Victory in Motion/Auburn Community Hospital and Virtua Health.

The BEAR Implant is a proprietary collagen-based implant used to facilitate torn ACL healing. 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 care standard, 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 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.

In patients 14 years and older who suffered an ACL injury with concomitant knee injuries, ACL restoration with the BEAR Implant reduces the risk of developing post-traumatic knee osteoarthritis (Kellgren-Lawrence grade 2 or higher), at six years post-surgery, compared to ACL reconstruction (ACLR) surgery using hamstring tendon autograft.

The BEAR Implant was first granted De Novo Approval b thye 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 growth plate disruption. 

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, which represents a paradigm shift in treating ACL tears.