Orthofix M6-C Artificial Cervical Disc – First US Patient Implants Following FDA Approval

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April 23, 2019

Orthofix Medical Inc. (NASDAQ:OFIX), has announced the first commercial implants of patients with the M6-C artificial cervical disc.

The Center for Disc Replacement at Texas Back Institute (TBI) in Dallas, Texas recently implanted four patients suffering from single level cervical disc degeneration with the newly approved M6-C disc — a next-generation artificial disc developed to replace an intervertebral disc damaged by cervical disc degeneration.

Designed with an artificial viscoelastic nucleus and fiber annulus that mimics the anatomic structure of a natural disc, the M6-C device is the only artificial cervical disc available in the U.S. that enables compression or “shock absorption” at the implanted level. The disc also provides a controlled range of motion when the spine transitions in its combined complex movements.

Drs. Scott Blumenthal, Jack Zigler, and Richard Guyer, orthopedic surgeons and co-medical directors for the Center for Disc Replacement at TBI, completed the initial commercial cases.

“The M6-C disc represents the continued evolution of artificial disc technology with its unique single piece compressible design and motion characteristics that mimic a person’s natural disc — features that have not been available in the U.S. until now,” said Blumenthal. “Our center was fortunate to be a part of the U.S. FDA IDE clinical study that provided data for the approval of the M6-C disc. Because of this, we now have study patients that are several years post-implant that are doing very well with this device. We are excited to be able to offer this next-generation option to patients with cervical disc degeneration who are candidates for artificial disc replacement.”

One such patient is Randy Fulton, an active duty firefighter and participant in the clinical study. “I was injured in a house fire that almost ended my career,” said Fulton, Fire Chief of the Pantego, Texas Fire Department. “Participating in the clinical study and receiving the M6-C disc helped me regain the natural movement that my disc had prior to being injured. It gave me a second chance to do what I love, which is to be a firefighter.”

“We are excited to begin providing access to this life-changing technology,” said Global President of Orthofix Spine Brad Niemann. “Orthofix is releasing the M6-C artificial cervical disc in 2019 through a controlled, limited market launch in the U.S. This is accompanied by an extensive training and education curriculum for surgeons in order to assist them in providing the best possible patient outcomes.”

The M6-C artificial cervical disc was developed to replace an intervertebral disc damaged by cervical disc degeneration. Designed to restore physiologic motion to the spine at the treated level, the M6-C disc is an alternative to cervical fusion for certain patients who are eligible for a total disc replacement. The M6-C artificial cervical disc preserves motion by restoring biomechanical function at the treated level after native disc removal and designed to potentially reduce subsequent degeneration of adjacent vertebral segments. Orthofix recently launched a new patient education website, www.M6disc.com, as a resource for those wishing to learn more about the device and the cervical disc replacement procedure.

The M6-C disc received U.S. Food and Drug Administration (FDA) approval in February 2019. Prior to U.S. launch, the device had received CE Mark approval for distribution in the European Union and other international geographies. To date there have been more than 45,000 implants of the M6-C artificial cervical disc outside of the U.S. The M6-C disc was developed by Spinal Kinetics, a company acquired by Orthofix in April 2018.



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