Bioengineered Repair Mimics Native ACL Says New Study

Results of a study published online in the American Journal of Sports Medicine show torn anterior cruciate ligaments (ACLs) treated with the Miach Orthopaedics, Inc., Bridge-Enhanced® ACL Repair (BEAR®) implant are similar to the contralateral (native) ACL at 12 months based on MRI imaging.

Background

Last covered on our pages as recently as March, Massachussetts based Miach Orthopaedics, Inc. develops bio-engineered surgical implants for connective tissue repair. The company’s initial focus is on the Bridge-Enhanced® ACL Repair (BEAR®) technology as a viable alternative to conventional ACL reconstruction for patients who have sustained an ACL injury.

Every year, approximately 200,000 ACL injuries occur in the U.S. Without treatment, the ACL does not heal, resulting in ACL reconstruction surgery being one of the most common orthopaedic procedures in the U.S. Traditional ACL reconstruction using an autograft or allograft stabilizes the knee but has drawbacks – primarily that only about 60 percent of patients can return to their sport at the same level, and the ACL re-tear rate can be nearly 30 percent for teens.

The BEAR® implant is intended to facilitate healing of the torn ACL. It is designed to be surgically placed between the torn ACL ends at the time of repair, and to hold a small amount of the patient’s blood in the wound site. The implant provides a scaffold that allows the torn ends of the ACL to heal back together. It is hoped this new technology will restore more normal anatomy and function of the knee, and thus enable a higher percentage of patients to get back to activities they enjoy. The BEAR implant is an investigational device and is only available in FDA-approved clinical trials.

The newly published study, “Changes in Cross-sectional Area and Signal Intensity of Healing Anterior Cruciate Ligaments and Grafts in the First 2 Years After Surgery,” compared 10 patients treated with the BEAR implant to 10 treated with traditional hamstring autografts, using the contralateral ACL as reference. The study showed ACLs treated with the BEAR implant had a cross-sectional area (quantity), signal intensity (quality) and sagittal orientation that were similar to the contralateral ACL at 12 months, whereas hamstring autografts were significantly larger and more vertically oriented than the native ACL at 24 months.

Clinician/Founder comments

“The results highlight the ability of the BEAR implant to restore the signal intensity and anatomy of the torn ACL to those of the native ACL,” said Martha Murray, M.D., professor of orthopaedic surgery at Harvard Medical School, an orthopaedic surgeon in the Sports Medicine Division at Boston Children’s Hospital and founder of Miach Orthopaedics. “MRIs from these two cohorts were helpful in comparing the changes over a two-year period, as well as the influences of other anatomic features of the knee after surgery. While more study is needed, these results show promise for the regenerative properties of the BEAR implant in restoring more normal knee anatomy.”

Company comments

“We are encouraged by the results of this study, which add to the growing body of evidence supporting use of the BEAR implant as a potential treatment option for people with torn ACLs,” said Martha Shadan, president and CEO, Miach Orthopaedics. “ACL repair using the BEAR implant is a new approach to an old problem that we think has the potential to improve outcomes for people with torn ACLs.” 

Source: Miach Orthopaedics, Inc

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