Miach Orthopaedics, Inc., a privately held company dedicated to developing bio-engineered surgical implants for connective tissue restoration, today announced initiation of the Bridge Registry Post-Market Study of the company’s Bridge-Enhanced ACL Restoration (BEAR®) Implant for anterior cruciate ligament (ACL) tears.
The Bridge Registry (NCT05398341) will assess real-world evidence of the BEAR Implant, with approval to enroll up to 750 patients at up to 30 sites in the U.S. 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.
“Our orthopedic sports medicine team at Rothman Orthopaedics Florida and AdventHealth are thrilled to offer our adult and pediatric patients the most innovative technologies to optimize patient recovery and performance after ACL injury,” said Dr. Daryl C. Osbahr, chief of orthopedic surgery at AdventHealth’s Rothman Orthopaedic Institute and co-lead principal investigator for the study. “The BEAR procedure and Bridge Registry enable our team to provide cutting edge techniques to our patients while also being focused on conducting research with the goal of continually refining our techniques based on evidence-based outcomes.”
The BEAR Implant serves as a bridge to restore the patient’s own ACL and is the first medical technology that has been clinically proven to enable healing of a torn ACL. It is a paradigm shift from the current standard of care – reconstruction that replaces the ACL with a graft. The BEAR Implant acts as a bridge to help the torn ends of the ACL heal together. It is designed to hold and protect the patient’s own blood in the gap between the ACL ends to allow the formation of a clot, which is necessary for healing.
“As we are now just over a year since our very first BEAR procedure, we continue to be impressed with the results,” said Dr. Sabrina Strickland, orthopedic surgeon at Hospital for Special Surgery and co-lead principal investigator for the study. “I look forward to being a part of the Bridge Registry, as careful follow-up of the outcomes of surgery allows us to accurately assess surgical techniques.”
Leading academic institutions currently recruiting patients include the following:
- AdventHealth (Florida) – Site PI: Dr. Sean Keyes
“The BEAR Implant is changing the way we manage young patients with ACL injuries. Talking about the BEAR Implant to my patients, and their parents, has turned into talking about the long-term health of their knee.” - Duke University (North Carolina) – Site PI: Dr. Brian Lau
“The BEAR Implant is a game changer for ACL surgery, and we are impressed with the early results. We are excited to be part of the Bridge Registry to follow our patients to continue to improve this new surgical technique.”
- Hospital for Special Surgery (New York) – Site PI: Dr. Sabrina Strickland
The following institutions will begin enrolling patients soon:
- Boston Children’s Hospital (Massachusetts) – Site PI: Dr. Dennis Kramer
- Ochsner Health System (Louisiana) – Site PI: Dr. Jeremy Burnham
- Stanford University School of Medicine (California) – Site PI: Dr. Seth Sherman
- Steamboat Orthopaedic & Spine Institute (Colorado) – Site PI: Dr. Alex Meininger
- Victory Sports Medicine / Auburn Community Hospital (New York) – Site PI: Dr. Marc Pietropaoli
- Virtua Health (New Jersey) – Site PI: Dr. Sean McMillan
“The Bridge Registry provides evidence to supplement the extensive base of clinical trial research that has been conducted on the BEAR Implant over the last few decades,” said Patrick McBrayer, president and CEO, Miach Orthopaedics. “The real-world evidence we collect through the registry will enable us to track key outcomes as the BEAR procedure is adapted for commercial use.”
About The BEAR® Implant
The Bridge-Enhanced ACL Restoration (BEAR®) Implant is a proprietary bio-engineered 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 between the two ends of the torn ACL. The surgeon injects a small amount of the patient’s own blood into the implant and inserts 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. The BEAR Implant is resorbed by the body as the ACL heals.
The BEAR Implant was granted De Novo Approval from the U.S. Food and Drug Administration in December 2020. It is indicated for skeletally mature patients at least 14 years of age with a complete rupture of the ACL, as confirmed by MRI. Patients must have an ACL stump attached to the tibia to facilitate the restoration.