Study will evaluate Cervical-Stim as an aid to current treatments
LEWISVILLE, Texas--(BUSINESS WIRE)--
Orthofix International N.V., (NASDAQ:OFIX), today announced the
Company's first large-scale clinical study to evaluate the use of pulsed
electromagnetic fields (PEMF) technology to see if the therapy can
improve osteogenesis (bone growth) in Type II odontoid fractures. The
study will examine the safety and effectiveness of PEMF treatment with
the Orthofix Cervical-Stim® device as an adjunct to standard
immobilization with a rigid collar.
"Typically we see Type II odontoid fractures in patients as the result
of a bad fall or a car accident," said Dr. Richard Guyer, orthopedic
spine surgeon and President of Texas Back Institute in Dallas, TX and an
investigator in the study. "Despite immobilization or in some cases
surgical fixation, often the bones do not heal correctly. Cervical PEMF
stimulation may provide us with an additional treatment approach that
can enhance odontoid fracture healing."
A prospective, double-blind, randomized, placebo-controlled, multicenter
clinical trial, the Odontoid Fracture Study will investigate the safety
and effectiveness of PEMF therapy with the Orthofix Cervical-Stim device
in patients with Type II fractures of the odontoid process. The study
will enroll approximately 360 patients who are 50 years of age or older
at up to 50 sites in the U.S. Study participants will be randomized in a
two-to-one ratio to either an active or placebo control (inactive)
device and followed for 12 months after initiation of treatment. The
odontoid study is a direct result of Orthofix's previously announced
strategy for conducting clinical trials to expand the Company's PEMF
indications.
"Initiation of the Odontoid Fracture Study represents an important step
in obtaining clinical evidence to support new indications and
reimbursement for our PEMF technology," said James Ryaby, Ph.D., Chief
Scientific Officer for Orthofix. "We are hopeful that the results of
this study will support the use of Cervical-Stim as an adjunct therapy
for managing patients with these difficult to treat injuries."
The Orthofix Cervical-Stim device is currently approved by the U.S. Food
and Drug Administration (FDA) as a noninvasive, adjunctive treatment
option for improving cervical fusion outcomes. The device uses a
low-level electromagnetic field (PEMF) that helps activate and augment
the body's natural healing process to enhance vertebral bone fusion. In
the study, the Cervical-Stim device will be worn directly over a rigid
collar. Use in the Odontoid Fracture Study is investigational and is
being conducted under an Investigational Device Exemption (IDE) from the
FDA. More information is available at ClinicalTrials.gov.
About Odontoid Fractures
The odontoid process is a small finger-like projection from the second
cervical vertebra (C2) around which the first cervical vertebra (C1)
rotates. The most common mechanisms of injury producing an odontoid
fracture are motor vehicle accidents or severe falls. For the elderly, a
fall from a standing position may cause such a fracture. When the bone
does not heal correctly as a result of an odontoid fracture, the base of
the skull may be unstable thereby placing the patient at risk for
neurological impairment and even death. Studies
show that odontoid fractures account for approximately 15 percent of all
cervical spine fractures. According to a 2010 report published by the
Agency for Healthcare Research and Quality, there are approximately
21,476 odontoid fractures annually in the U.S. The most common
classification is Type II which accounts for 65 percent of all odontoid
fractures or approximately 13,960 yearly. Currently there are no
therapies that accelerate healing and improve long-term outcomes in
these patients.
About Orthofix
Orthofix International N.V. is a diversified, global medical device
company focused on improving patients' lives by providing superior
reconstructive and regenerative orthopedic and spine solutions to
physicians worldwide. Headquartered in Lewisville, TX, the company has
four strategic business units that include BioStim, Biologics, Extremity
Fixation and Spine Fixation. Orthofix products are widely distributed
via the company's sales representatives, distributors and subsidiaries.
In addition, Orthofix is collaborating on research and development
activities with leading clinical organizations such as the
Musculoskeletal Transplant Foundation and the Texas Scottish Rite
Hospital for Children. For more information, please visit www.orthofix.com.
Forward-Looking Statements
This communication contains certain forward-looking statements under the
Private Securities Litigation Reform Act of 1995. These forward-looking
statements, which may include, but are not limited to, statements
concerning the projections, financial condition, results of operations
and businesses of Orthofix and its subsidiaries and are based on
management's current expectations and estimates and involve risks and
uncertainties that could cause actual results or outcomes to differ
materially from those contemplated by the forward-looking statements.
The forward-looking statements in this release do not constitute
guarantees or promises of future performance. Factors that could cause
or contribute to such differences may include those described in our
annual report on Form 10-K for the fiscal year ended December 31, 2013
and other subsequent periodic reports filed by the Company with the SEC.
Existing and prospective investors are cautioned not to place undue
reliance on these forward-looking statements, which speak only as of the
date hereof. The Company undertakes no obligation to update or revise
the information contained in this press release.
Orthofix International N.V.
Mark Quick, 214-937-2924
Investor
Relations
markquick@orthofix.com
or
Denise
Landry, 214-937-2529
Media Relations
deniselandry@orthofix.com
Source: Orthofix International N.V.
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