With more than 100,000 implantations worldwide,
the M6-C and M6-L discs continue to demonstrate strong clinical
performance, safety and patient benefits
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.”
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 82.3 percent as compared to 67.0
percent in the control group. The rates of M6-C disc subsequent
surgical interventions (SSI) were 3.1 percent, device or
procedure-related serious adverse events (SAE) were 3.1 percent and
were similar to ACDF rates of SSI at 5.3 percent and SAE failure
equaling 4.8 percent. The M6-C disc received U.S. Food and Drug
Administration (FDA) approval in February 2019 based on the
two-year results of this study.
“To date there have been more than 100,000 implantations of M6
artificial disc technology in 20 countries around the world,” said
Kevin Kenny, President, Orthofix Global Spine. “We are proud of
this life-changing technology that has helped so many people get
back to enjoying their lives.”
About the M6-C Artificial Cervical Disc
The M6‑C artificial cervical disc is designed to maintain the
natural behavior of a functional spinal unit by replicating the
biomechanical characteristics of the native disc and is indicated
as an alternative to cervical fusion. The unique design of the M6-C
disc features a compressible viscoelastic nuclear core and an
annular structure construct that allows for shock absorption at the
implanted level, as well as providing a controlled range of motion
when the spine transitions in its combined complex movements.
Orthofix invites those attending the Cervical Spine Research
Society (CSRS) Annual Meeting in Las Vegas, November 29 through
December 2, 2023, to visit booth #109 to learn more about the
company’s full portfolio of cervical solutions.
About Orthofix
Orthofix is a leading global spine and orthopedics company with
a comprehensive portfolio of biologics, innovative spinal hardware,
bone growth therapies, specialized orthopedic solutions, and a
leading surgical navigation system. Its products are distributed in
approximately 68 countries worldwide.
The Company is headquartered in Lewisville, Texas, where it
conducts general business, product development, medical education
and manufacturing, and has primary offices in Carlsbad, CA, with a
focus on spine and biologics product innovation and surgeon
education, and Verona, Italy, with an emphasis on product
innovation, production, and medical education for orthopedics. The
combined company’s global R&D, commercial and manufacturing
footprint also includes facilities and offices in Irvine, CA,
Toronto, Canada, Sunnyvale, CA, Wayne, PA, Olive Branch, MS,
Maidenhead, UK, Munich, Germany, Paris, France, and São Paulo,
Brazil. To learn more, visit Orthofix.com.
Forward-Looking Statements
This news release may include forward-looking statements within
the meaning of Section 21E of the Securities Exchange Act of 1934,
as amended, and Section 27A of the Securities Act of 1933, as
amended. 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,” “continue” or other comparable
terminology. Orthofix cautions you that statements included in this
news release that are not a description of historical facts are
forward-looking statements that are based on the Company’s current
expectations and assumptions. Each forward-looking statement
contained in this news release is subject to risks and
uncertainties that could cause actual results to differ materially
from those expressed or implied by such statement. Applicable risks
and uncertainties include, among others: the ability of newly
launched products to perform as designed and intended and to meet
the needs of surgeons and patients, including as a result of the
lack of robust clinical validation; and the risks identified under
the heading “Risk Factors” in Orthofix Medical Inc.’s Annual Report
on Form 10-K for the fiscal year ended December 31, 2022, which was
filed with the Securities and Exchange Commission (SEC) on March 6,
2023. The Company’s public filings with the Securities and Exchange
Commission are available at www.sec.gov. You are cautioned not to
place undue reliance on forward-looking statements, which speak
only as of the date when made. Orthofix does not intend to revise
or update any forward-looking statement set forth in this news
release to reflect events or circumstances arising after the date
hereof, except as may be required by law.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231129606400/en/
Media Relations Denise Landry DeniseLandry@orthofix.com
214.937.2529
Investor Relations Louisa Smith, Gilmartin Group
IR@orthofix.com
Orthofix Medical (NASDAQ:OFIX)
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