Miach Orthopaedics, a privately held company dedicated to developing bio-engineered surgical implants for connective tissue restoration, announced the first patient has been treated in the company’s BEAR III study of the BEAR Implant—the first medical technology to clinically demonstrate that it enables healing of a patient's torn anterior cruciate ligament (ACL). Miach initiated BEAR III to continue to build upon the extensive base of evidence for the BEAR Implant, which recently received De Novo approval from the U.S. Food and Drug Administration.
 
BEAR III is a single-arm, multi center cohort study enrolling 250 patients, all of whom will receive the BEAR Implant and will be followed for 10 years. The first patient, a 32-year-old male with a mid-substance ACL tear, was treated at MedStar Surgery Center at Timonium, an outpatient site affiliated with Medstar Union Memorial Hospital in Baltimore, Maryland.
 
“The BEAR Implant is a promising new technology that could improve the way ACL tears are treated,” said Dr. Richard Levine, the orthopedic surgeon who performed the surgery. “The BEAR Implant offers patients a treatment option to restore their ACL instead of reconstructing it with a graft.”
 
The BEAR III Trial for Bridge-Enhanced ACL (Anterior Cruciate Ligament) Restoration (NCT03348995) is or will soon be enrolling patients at orthopedic centers in Georgia, Louisiana, Maryland, Massachusetts, New Jersey, Rhode Island, and South Dakota.
 
“We have seen consistently positive results in the BEAR I and BEAR II studies,” said Martha Shadan, president and CEO, Miach Orthopaedics. “We’re excited to have some of the leading orthopedic centers across the U.S. partnering with us on BEAR III as we continue to add to our extensive base of clinical evidence for the BEAR Implant.”