Clinical trial will evaluate new application for Company's
LEWISVILLE, Texas--(BUSINESS WIRE)--
Orthofix International N.V., (NASDAQ:OFIX), a diversified, global
medical device company, today announced enrollment of the first patient
in a study evaluating the use of pulsed electromagnetic field (PEMF)
technology for osteoarthritis (OA) of the knee. This study will assess
the efficacy and safety of the Company's Physio-Stim system in reducing
inflammation and restoring homeostasis of the extracellular matrix,
potentially providing symptomatic relief of OA pain, reducing cartilage
breakdown and stimulating new cartilage formation. If successful, this
would be the first disease-modifying treatment for osteoarthritis.
Preservation or restoration of joint structure together with reduction
of inflammation would be expected to improve symptoms and reduce the
need for surgical intervention.
The first patient in the study was enrolled by Dr. Roy Aaron, Professor
at Brown University in Providence, RI. "Finding new solutions for OA of
the knee is important as these patients not only suffer from pain, they
often have a high level of disability from the disease and often seek
costly surgical solutions," said Dr. Aaron. "We are hopeful that active
PEMF stimulation may provide us with a new non-invasive treatment
approach that could help patients with knee OA avoid surgery and improve
their overall quality of life."
The OA of the knee study is a prospective, randomized, double-blind,
placebo-controlled feasibility trial that will enroll approximately 150
patients who are 40 years of age or older at three sites in the U.S.
These include Brown University School of Medicine in Providence, RI;
Sinai Hospital of Baltimore in Baltimore, MD; and the Cleveland Clinic
in Cleveland, OH. 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.
"This study demonstrates Orthofix's vision of developing new
applications for our PEMF technology," said James Ryaby, Ph.D., Chief
Scientific Officer for Orthofix. "We are proud to conduct research
studies like these in order to find solutions for patients who live with
disabling diseases and conditions such as OA."
The Orthofix Physio-Stim device is currently approved by the U.S. Food
and Drug Administration (FDA) for the treatment of nonunion fractures.
The device uses a low-level electromagnetic field (PEMF) that helps
activate and augment the body's natural healing process. Use in the OA
study is investigational and is being conducted under an Investigational
Device Exemption (IDE) from the FDA. More information is available at ClinicalTrials.gov.
About Osteoarthritis of the Knee
Osteoarthritis is a common disease and one of the leading causes of
disability. The Centers
for Disease Control and Preventionestimate that nearly one in two
people may develop symptomatic knee OA by age 85. Statistics show that
in 2011 alone, there were 757,000 total knee replacement procedures
performed, with OA accounting for 95 percent of these surgeries.
Osteoarthritis of the knee is a degenerative, "wear-and-tear" type of
arthritis where the cartilage in the knee joint gradually wears away.
This painful disease most often effects people 50 years of age and
older, but may occur in younger people, too. People with OA of the knee
often experience pain when walking, running, bending or kneeling. They
may also experience joint stiffness and swelling, making it difficult to
do many everyday activities.
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 Brown University,
Sinai Hospital of Baltimore, Cleveland Clinic, Texas Scottish Rite
Hospital for Children and the Musculoskeletal Transplant Foundation. For
more information, please visit www.orthofix.com.
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, 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, but are not limited to
the risks described in the "Risk Factors" section of our 2015 Annual
Report on Form 10-K, as well as in other reports that we file in the
future. 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.
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Orthofix International N.V.
Denise Landry, 214-937-2529
Source: Orthofix International N.V.
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