WESTBOROUGH, Mass.–(BUSINESS WIRE)–#ACLrepair—Miach Orthopaedics, Inc., a company transforming the treatment of anterior cruciate ligament (ACL) tears with the BEAR® Implant, today announced the presentation of one- and two-year results of the Bridge Registry study at the recent American Orthopaedic Society for Sports Medicine (AOSSM) annual meeting.
Two-year results of the Bridge Registry, presented by Dr. Brian Lau and Dr. Jocelyn Wittstein of Duke University, demonstrated a retear rate of 5% among the first 100 patients enrolled, including:
One-year results showing an earlier analysis of these and other outcomes were shared in a poster (P224).
“We are seeing reassuringly low failure rates in the Bridge Registry, which is studying real-world implementation of ACL restoration with the BEAR Implant,” said Dr. Jacqueline Brady, orthopedic surgeon at Oregon Health and Science University and co-principal investigator of the Bridge Registry study. “It is important that we study this exciting new technology as we make adjustments for real-world use, such as stronger sutures and different fixation techniques to aid in direct visualization and restored anatomy of the repair, and I am honored to be part of this research in the Bridge Registry.”
The Bridge Registry (NCT05398341) 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 International Knee Documentation Committee (IKDC) Subjective Knee Evaluation at two years and knee laxity measured with Lachman scoring at one year. In addition to Dr. Brady, study co-principal investigators are Dr. Sabrina Strickland of Hospital for Special Surgery and Dr. Jocelyn Wittstein of Duke University.
“The positive outcomes demonstrated in the Bridge Registry support the continued safety and efficacy of the BEAR Implant, as evidenced by a low retear rate of 5%,” said Patrick McBrayer, president and CEO, Miach Orthopaedics. “This and other registry data provide important insights into the real-world use of the BEAR Implant, accounting for variations in patient age, activity level and ACL tear type, as well as surgical technique.”
To date 300 patients have been enrolled in the Bridge Registry at the following sites:
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.
Contacts
MEDIA CONTACT:
Joni Ramirez
Merryman Communications
joni@merrymancommunications.com
323-532-0746
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