Orthofix Announces FDA Approval of the M6-C Artificial Cervical Disc to Treat Patients with Cervical Disc Degeneration

Only Artificial Cervical Disc that Mimics the Anatomic Structure of a
Natural Disc


LEWISVILLE, Texas–(BUSINESS WIRE)–Orthofix Medical Inc. (NASDAQ:OFIX), a global medical device company
focused on musculoskeletal products and therapies, today announced U.S.
Food and Drug Administration (FDA) approval of the M6-C
artificial cervical disc for patients suffering from cervical disc
degeneration. The M6-C artificial cervical disc was developed by Spinal
Kinetics, a company acquired by Orthofix in April 2018.

“With the approval of the M6-C artificial cervical disc, Orthofix now
has the industry’s most comprehensive portfolio of cervical spine
products to best serve our surgeon customers and patients,” said
Orthofix President and Chief Executive Officer, Brad Mason. “In addition
to a full line of anterior, posterior and interbody fusion cervical
implants, we offer the CervicalStim device, the only
FDA-approved cervical bone growth stimulation therapy, and the Trinity
ELITE® allograft, a market-leading allograft developed in
partnership with MTF Biologics. The launch of the M6-C artificial
cervical disc in the U.S. will complement this existing spine portfolio
and represents a significant milestone in the execution of our strategy
to accelerate topline growth.”

The M6-C artificial cervical disc is a next-generation artificial disc
developed to replace an intervertebral disc damaged by cervical disc
degeneration. Designed to restore physiologic motion to the spine, the
M6-C disc is indicated as an alternative to cervical fusion. The M6-C
artificial cervical disc preserves motion by restoring biomechanical
function at the treated level after native disc removal and potentially
reduces subsequent degeneration of adjacent vertebral segments. The M6-C
device is the only artificial cervical disc that mimics the anatomic
structure of a natural disc by incorporating an artificial visco-elastic
nucleus and fiber annulus into its design. 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.

Pre-market approval was based on clinical data from a U.S.
Investigational Device Exemption (IDE) study that evaluated the safety
and effectiveness of the M6-C artificial cervical disc compared to
anterior cervical discectomy and fusion (ACDF) for the treatment of
symptomatic cervical radiculopathy with or without cord compression.
Patients in the study presented with degenerative cervical radiculopathy
requiring surgical intervention, and confirmed clinically and
radiographically at one vertebral level from C3 to C7.

Study results at 24 months include the following clinical patient
outcomes:

  • 90.5 percent of patients who received the M6-C disc demonstrated a
    meaningful clinical improvement in the Neck Disability Index.
  • A meaningful clinical improvement in arm pain score was seen in 91.2
    percent of the M6-C disc patients compared to 77.9 percent in ACDF
    patients. In addition, this same meaningful improvement was seen in
    neck pain scores with 90.5 percent of patients who received the M6-C
    disc compared to 79.9 percent in patients who underwent the ACDF
    procedure.
  • The M6-C disc preserved range of motion in flexion-extension and
    lateral bending in the study group.
  • 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,
    14.0 percent of the M6-C disc patients were still taking some type of
    pain medication compared to 38.2 percent of the ACDF patients.

    • Of the patients still taking pain medication there was a seven
      times higher rate of opioid use with the ACDF patients than with
      patients who received the M6-C disc.
  • Additional 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.

The prospective, non-randomized, concurrently controlled, multi-center
clinical trial was conducted at 23 sites in the United States.

“Cervical disc degeneration is a common condition that can cause pain in
the neck, shoulders, arms and hands and lead to numbness and weakness in
the arm or hands. Often this condition is the result of a vertebral disc
that has deteriorated or been damaged due to the natural aging process
or an injury,” said Dr. Rick Sasso, orthopedic spine surgeon, professor
and chief of spine surgery at the Indiana University School of Medicine
in Indianapolis and an investigator in the M6-C artificial cervical disc
IDE study. “For many of these patients, the M6-C artificial cervical
disc will give us the ability to replace the patient’s damaged disc with
one that closely mimics their natural disc, enabling them to regain
motion and return to their normal activities.”

Orthofix expects to release 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 and there
have been more than 45,000 implants of the M6-C artificial cervical disc
outside of the U.S. to date.

Conference Call

The Company will conduct a conference call to discuss the FDA approval
of the M6-C artificial cervical disc along with its fourth quarter and
fiscal 2018 financial results on Monday, February 25 at 3:30 p.m.
Central time (4:30 p.m. Eastern time). Interested parties may access the
conference call by dialing (844) 809-1992 in the U.S. and (612) 979-9886
outside the U.S., and referencing the conference ID 7446347. A replay of
the call will be available for two weeks by dialing (855) 859-2056 in
the U.S. and (404) 537-3406 outside the U.S., and entering the
conference ID 7446347. A webcast of the conference call may be accessed
by going to the Company’s website www.orthofix.com
by clicking on the Investors link and then the Events and Presentations
page.

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 seventy 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
[email protected]

Denise Landry
Media Relations
214 937 2529
[email protected]