The M6-C Disc is the Only Artificial Disc Available in the US that
offers Compression like a Natural Disc
LEWISVILLE, Texas--(BUSINESS WIRE)--Apr. 23, 2019--
Orthofix Medical Inc. (NASDAQ:OFIX), a global medical device company
focused on musculoskeletal products and therapies, today 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.
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The M6-C™ artificial cervical disc is a next-generation artificial disc developed to replace an intervertebral disc damaged by cervical disc degeneration. (Photo: Business Wire)
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.
About Orthofix
Orthofix Medical Inc. is a global medical device company focused on
musculoskeletal products and therapies. The Company’s mission is to
improve patients' lives by providing superior reconstruction and
regenerative musculoskeletal solutions to physicians worldwide.
Headquartered in Lewisville, Texas, Orthofix’s spine and orthopedic
extremities products are distributed in more than 70 countries via the
Company's sales representatives and distributors. For more information,
please visit www.orthofix.com.
Forward-Looking Statements
This communication contains forward-looking statements within the
meaning of Section 21E of the Securities Exchange Act of 1934, as
amended (“the Exchange Act”), and Section 27A of the Securities Act of
1933, as amended, which are based on our current beliefs, assumptions,
expectations, estimates, forecasts and projections. These
forward-looking statements involve risks, uncertainties, assumptions and
other factors which, if they do not materialize or prove correct, could
cause Orthofix’s results to differ materially from historical results or
those expressed or implied by such forward-looking statements.
Therefore, our actual outcomes and results may differ materially from
those expressed in these forward-looking statements. In some cases, you
can identify forward-looking statements by terminology such as “may,”
“will,” “should,” “expects,” “plans,” “anticipates,” “believes,”
“estimates,” “projects,” “intends,” “predicts,” “potential,” or
“continue” or other comparable terminology. The potential risks and
uncertainties that could cause actual growth and results to differ
materially include, but are not limited to: the risk that spine surgeons
may be slow to adopt the M6-C artificial cervical disc; the risk that
future patient studies or clinical experience and data may indicate that
treatment with the M6-C artificial cervical disc does not improve
patient outcomes, or otherwise call into question the benefits of its
use to patients, hospitals and surgeons; the risk that the product may
not perform as intended and may therefore not achieve commercial
success; the risk that competitors may develop superior products or may
have a greater market position enabling more successful
commercialization; the risk that insurance payers may refuse to
reimburse healthcare providers for the use of our products; and other
risks and uncertainties more fully described in Orthofix’s periodic
filings with the Securities and Exchange Commission, including under the
heading “Risk Factors” in our annual and quarterly reports. You should
not place undue reliance on any of these forward-looking statements.
Further, any forward-looking statement speaks only as of the date
hereof, unless it is specifically otherwise stated to be made as of a
different date. We undertake no obligation to further update any such
statement to reflect new information, the occurrence of future events or
circumstances or otherwise.
View source version on businesswire.com: https://www.businesswire.com/news/home/20190423005343/en/
Source: Orthofix Medical Inc.
Mark Quick
Investor Relations
214 937 2924
markquick@orthofix.com
Denise Landry
Media Relations
214 937 2529
deniselandry@orthofix.com