Presented for the First Time during ISASS, Data also Shows Reduction
in Pain and Opioid Medication Use
LEWISVILLE, Texas–(BUSINESS WIRE)–Orthofix Medical Inc. (NASDAQ:OFIX), a global medical device company
focused on musculoskeletal products and therapies, today announced the
full two-year outcomes from its U.S. Investigational Device Exemption
(IDE) study of the M6-C™ artificial cervical disc.
Dr. Jack Zigler, orthopedic spine surgeon at Texas Back Institute and an
investigator in the study, presented the study results during the
International Society for the Advancement of Spine Surgery (ISASS)
annual meeting in Anaheim, California.
The data demonstrates that patients treated with the M6-C artificial
cervical disc had significant improvements in neck and arm pain,
function and quality of life scores. Additionally, these patients had a
significant difference in the reduction of pain and opioid medications
use when compared to anterior cervical discectomy and fusion (ACDF)
patients. At 24 months, patients in the ACDF group who were still using
pain medications had a seven times higher rate of opioid use than those
in the M6-C disc group.
“The results from the M6-C artificial cervical disc IDE clinical study
continue to validate the positive outcomes of cervical disc arthroplasty
versus discectomy with fusion,” said Zigler. “A significant reduction in
pain, the maintenance or improvement of neurological function, and the
preservation of natural disc motion after 24 months were all meaningful
clinical benefits the M6-C disc patients experienced when compared to
the fusion control. Additionally, patients receiving the M6-C disc were
able to significantly lower their use of NSAIDs – and more importantly –
significantly lower their use of opioid medications.”
A prospective, non-randomized, concurrently controlled clinical trial,
the M6-C IDE study was conducted at 23 sites in the United States with
an average patient age of 44 years. The study evaluated the safety and
effectiveness of the M6-C artificial cervical disc compared to ACDF for
the treatment of single level symptomatic cervical radiculopathy with or
without cord compression. The overall success rate for the
protocol-specified primary endpoint for the M6-C disc patients was 86.8
percent at 24 months and 79.3 percent in the control group. This data
statistically demonstrates that cervical disc replacement with the M6-C
disc is not inferior to treatment with ACDF.
Secondary outcomes at 24 months include:
-
Patients who received the M6-C disc demonstrated statistically
significant improvement in the Neck Disability Index as measured at
week six and months three, six, 12 and 24. -
Meaningful clinical improvement was seen in the following pain scores:
-
91.2 percent of patients who received the M6-C disc reported an
improvement in neck pain compared to 77.9 percent in patients who
underwent the ACDF procedure. -
90.5 percent of the M6-C patients reported improvement in arm pain
scores compared to 79.9 percent in ACDF patients.
-
91.2 percent of patients who received the M6-C disc reported an
-
Prior to surgery, 80.6 percent of the M6-C disc patients and 85.7
percent of the ACDF patients were taking some type of pain medication
for the treatment of their cervical spine condition. At 24 months, the
rate of M6-C patients who were still taking some type of pain
medication dropped to 14.0 percent compared to 38.2 percent of the
ACDF patients.-
Of these, there was a seven times higher rate of opioid use with
the ACDF patients than with patients who received the M6-C disc.
-
Of these, there was a seven times higher rate of opioid use with
-
There was a statistically significant difference in the average mean
surgery time – 74.5 minutes for patients receiving the M6-C disc
versus 120.2 minutes for those patients having the ACDF procedure. -
In addition, there was a statistically significant difference in the
mean length of hospital stay – 0.61 days for the M6-C patients versus
1.10 days for ACDF patients. -
Subsequent surgery at the treated level was needed in 4.8 percent of
the ACDF patients compared to 1.9 percent of the M6-C disc patients. - There were no device migrations reported in the study.
-
Overall patients receiving the M6-C disc reported a 92-percent
satisfaction rate with the surgery, and 93 percent said they would
have the surgery again. -
There were 3.8 percent serious adverse events related to the device or
procedure in the M6-C disc group versus 6.1 percent in the ACDF group.
The M6-C disc received U.S. Food and Drug Administration (FDA) approval
in February 2019 based on the results of this study.
“With the recent FDA approval of the M6-C artificial cervical disc, we
are excited to be able to provide spine surgeons and their patients a
new and innovative alternative to the ball-and-socket artificial disc
designs currently available in the U.S.,” said Global President of
Orthofix Spine Brad Niemann. “What makes the M6-C disc so unique is its
physiologic single-piece design featuring an artificial nucleus and
annulus that work together to mimic the biomechanical motion of a
natural disc to include axial compression or shock absorption, which no
other disc available in the U.S. has to offer.”
About the M6-C Artificial Cervical Disc
The M6-C artificial cervical disc is a next-generation intervertebral
disc designed to restore physiologic motion to the spine and is
indicated as an alternative to cervical fusion. The device is comprised
of ultra-high molecular weight polyethylene fiber wrapped in a specific
pattern, with multiple redundant layers that create a fiber matrix
(artificial annulus). The fiber is then wound around a polycarbonate
urethane polymer core creating an artificial nucleus. Like a natural
disc, this unique construct allows for shock absorption at the implanted
level, as well as provides a controlled range of motion when the spine
transitions in its combined complex movements.
Orthofix is releasing the M6-C artificial cervical disc in 2019 through
a controlled, limited market launch in the U.S. accompanied by an
extensive training and education curriculum for surgeons.
The M6-C artificial cervical disc received CE Mark approval for
distribution in the European Union and other international geographies
in 2006; there have been more than 45,000 implants of the M6-C
artificial cervical disc outside of the U.S. to date.
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.
Contacts
Mark Quick
Investor Relations
214 937 2924
markquick@orthofix.com
Denise Landry
Media Relations
214 937 2529
deniselandry@orthofix.com