Westborough, Massachusetts – (BUSINESS WIRE) – Miach Orthopaedics, Inc., a privately held company dedicated to the development of bioengineered surgical implants for connective tissue repair, announced today that the company’s BEAR III research has Treated the first patient ® implant-the first medical technology that has been clinically proven to heal a patient's torn anterior cruciate ligament (ACL). Miach initiated BEAR III to continue to build an extensive evidence base for the BEAR implant, which was recently approved by the U.S. Food and Drug Administration's De Novo.
BEAR III is a single-arm, multi-center cohort study that recruited 250 patients, all of whom will receive BEAR implants and will be followed up for 10 years. The first patient was a 32-year-old man with an intermediate ACL tear. He was treated at the MedStar Surgery Center in Timonium, an outpatient center of Medstar Union Memorial Hospital in Baltimore, Maryland.
"BEAR implants are a promising new technology that can improve the treatment of ACL tears," said Dr. Richard Levine, the plastic surgeon who performed the operation. "BEAR implants provide patients with a treatment option to restore their ACL instead of reconstructing it with a graft."
The BEAR III bridge-enhanced ACL (anterior cruciate ligament) repair trial (NCT03348995) is recruiting patients at orthopedic centers in Georgia, Louisiana, Maryland, Massachusetts, New Jersey, Rhode Island, and South Dakota.
"We have consistently seen positive results in the BEAR I and BEAR II studies," said Martha Shadan, President and CEO of Miach Orthopaedics. "We are very pleased to have some of the leading orthopedic centers in the United States working with us on BEAR III as we continue to add to the extensive clinical evidence base for BEAR implants."
The Bridge-Enhanced® ACL Restoration (BEAR®) implant is a proprietary bioengineered implant used to promote the healing of torn ACLs. 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 use a donor tendon. The BEAR implant acts as a bridge between the 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 operation. The combination of the BEAR implant and the patient's blood allows the body to heal the ends of the ACL tear together while maintaining the original connection between the ACL and the femur and tibia. As the ACL heals, the BEAR implant will be absorbed by the body.
The BEAR implant was approved by the U.S. Food and Drug Administration's De Novo in December 2020. It is suitable for mature skeletal patients over 14 years old with complete ACL fracture, confirmed by MRI. The patient must connect the ACL stump to the tibia to facilitate repair. The BEAR device must be implanted within 50 days of injury.
Miach Orthopaedics, Inc. is a private company located in Westborough, Massachusetts, dedicated to the development of bioengineered surgical implants for connective tissue repair. The company’s initial focus was on Bridge-Enhanced® ACL Restoration (BEAR®) implants, which represented a paradigm shift in ACL tear treatment from reconstruction to repair. The BEAR technology was pioneered by Martha Murray, MD, the founder of Miach Orthopaedics of Orthopaedics Surgery, Boston Children's Hospital. The initial research funding was provided by the NFL Players Association, Boston Children's Hospital and the National Institutes of Health. For more information about Miach Orthopedics and its products, please visit www.miachortho.com and follow the company on Facebook, Twitter and LinkedIn.
Joni Ramirez Merryman Communications joni@merrymancommunications.com 323-532-0746
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