Clinical trial will evaluate the Company's proprietary PEMF
technology for reducing tendon retears
LEWISVILLE, Texas--(BUSINESS WIRE)--
Orthofix International N.V., (NASDAQ:OFIX), a global medical device
company focused on musculoskeletal healing products and value-added
services, today announced that enrollment has begun in a study that will
evaluate the use of pulsed electromagnetic field (PEMF) technology for
rotator cuff repair. This study will assess the efficacy and safety of
the Company's RCStim™ device as an adjunctive treatment to
surgical repair of full thickness rotator cuff tears.
The study will evaluate if PEMF technology that is currently used to
promote bone growth can reduce the rate of repaired tendons being
subsequently torn again and improve overall patient outcomes. The study
will also gather data to see if there is a correlation between patients
treated with PEMF and improvements in muscle strength and range of
motion and a decrease in pain scores.
"Arthroscopic repair of rotator cuff tears can improve pain and
functional use of the shoulder but a continuing challenge is the high
retear rates after repair," said Dr. Andrew Kuntz, an orthopedic
shoulder surgeon at the Perelman School of Medicine at the University of
Pennsylvania in Philadelphia and an investigator in the clinical study.
"If PEMF therapy can prove effective in improving the patient's ability
to heal after repair surgery, this could provide us with a way to lower
the number of revision surgeries and improve overall outcomes."
The PEMF study for rotator cuff repair is a prospective, randomized,
double-blind, placebo-controlled trial that will enroll approximately
538 patients who are between 21 and 80 years of age at up to 30 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
24 months after initiation of treatment.
"PEMF technology has been used for many years to promote bone growth and
the healing of nonunion fractures," said James Ryaby, Ph.D., Chief
Scientific Officer for Orthofix. "The rotator cuff clinical trial is
based on our compelling pre-clinical research and it is our second
ongoing study evaluating PEMF therapy for a soft tissue application. As
we previously announced, we also have a study for Osteoarthritis
of the Knee for providing symptomatic relief of OA pain, reducing
cartilage breakdown and stimulating new cartilage formation. Ultimately,
if results of these studies are positive, it could open the door to
important new applications of this technology."
The Orthofix RCStim device is an investigational device and use in the
study is being conducted under an Investigational Device Exemption (IDE)
from the U.S. Food and Drug Administration (FDA). More information about
the study is available at ClinicalTrials.gov.
Orthofix PEMF technology devices are currently approved by the FDA for
the treatment of nonunion fractures that have not healed or have
difficulty healing and as an adjunct to cervical and lumbar spinal
fusions. To learn more please visit bonegrowththerapy.com.
About Rotator Cuff Tears
According to the American
Academy of Orthopaedic Surgeons, rotator cuff tears send as many as
two million Americans to their physicians' offices every year, many with
a full-thickness or complete tear. A full-thickness tear means the
tendon has separated from the bone. This common musculoskeletal injury
often requires surgical intervention. An estimated 250,000 patients get
rotator cuff surgery in the U.S. annually.
Orthofix International N.V. is a global medical device company focused
on musculoskeletal healing products and value-added services. The
Company's mission is to improve patients' lives by providing superior
reconstruction and regenerative orthopedic and spine solutions to
physicians worldwide. Headquartered in Lewisville, Texas, the Company
has four strategic business units: BioStim, Extremity Fixation, Spine
Fixation, and Biologics. Orthofix products are widely distributed via
the Company's sales representatives and distributors. 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
risks described in the "Risk Factors" section of our Annual Report on
Form 10-K for the fiscal year ended December 31, 2016, 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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