Orthofix Announces Publication in The Spine Journal of Five-Year Data for the M6-C Artificial Cervical Disc

Orthofix Medical Inc. (NASDAQ:OFIX), a leading global spine and orthopedics company, today announced the publication of the five-year results from the U.S. clinical study comparing the M6-C artificial cervical disc with anterior cervical discectomy and fusion (ACDF). Published in The Spine Journal, patients treated with the M6-C disc demonstrated superior clinical success at 60 months compared to ACDF patients. Secondary findings indicated significant improvements in neck and arm pain, function, and quality of life scores. The M6-C patient group maintained the flexion-extension and lateral bending motion reported at earlier time points. The publication of this data coincides with the recognition that more than 100,000 implantations of the M6-C artificial cervical disc and the M6-L artificial lumbar disc (only available outside the U.S.) have been performed worldwide since the product’s first introduction in 2006.

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The Orthofix M6-C artificial cervical disc is a next-generation artificial disc developed to replace an intervertebral disc damaged by cervical disc degeneration. The M6-C disc is designed to restore motion to the spine and is an alternative to cervical fusion. (Photo: Business Wire)

“Publication of this data is important as it validates the strong clinical performance observed in the five-year data from the U.S. IDE study,” said lead author Dr. Frank Phillips, Professor of Orthopedic Surgery at Rush University Medical Center in Chicago and the Principal Investigator for the FDA clinical trial. “Artificial cervical disc replacement is becoming the gold standard of care for indicated patients who may otherwise be facing cervical disc fusion. Data from this study show that the M6-C artificial disc demonstrated superior five-year achievement of clinical success when compared to ACDF controls. In addition, significantly more subjects in the M6-C group reported improved pain and physical functioning scores than observed in ACDF subjects, with no difference in re-operation rates or safety outcomes.”