Devices unveiled today at AAOS Annual Meeting in New Orleans
LEWISVILLE, Texas--(BUSINESS WIRE)--
Orthofix International N.V., (NASDAQ:OFIX), a global medical device
company focused on musculoskeletal healing products and value added
services, announced the U.S. Food and Drug Administration (FDA) and
European CE Mark approvals for its next-generation PhysioStim™
bone growth stimulators.
This press release features multimedia. View the full release here:
Orthofix PhysioStim Bone Growth Stimulator (Photo: Business Wire)
The PhysioStim devices provide a non-surgical treatment option for
patients who have a nonunion fracture to an extremity that has shown no
visible signs of healing. These Class III medical devices use a pulsed
electromagnetic field (PEMF) signal to induce a low-level electrical
field at the fracture site which stimulates bone healing.
"We are proud to provide physicians with these next-generation devices
that will enable them to redefine how patients with nonunion fractures
are treated," said Brad Niemann, President of the Orthofix BioStim
strategic business unit. "These devices are built on our proprietary
PEMF technology platform. Together with our spinal fusion stimulators,
they are currently the No. 1 prescribed bone growth stimulators in the
The PhysioStim devices will be accompanied by a new application for
mobile devices, STIM onTrack™. Designed for use with
smartphones and other mobile devices, STIM onTrack is free and available
in the U.S. through the iTunes App Store. The STIM onTrack mobile app
includes a first-to-market feature that enables physicians to remotely
view patient adherence to their prescription. Additionally, the app
engages patients in their recovery process through treatment calendars,
therapy reminders and educational resources.
"Bone growth stimulation therapy is a safe, effective and proven
treatment for patients who have a fracture to an extremity that won't
heal," said James Ryaby, Ph.D., Chief Scientific Officer at Orthofix.
"When patients follow their prescription, their rate of successful
healing is improved. The new mobile app is a great tool to foster better
adherence to the prescribed treatment because it empowers the patient to
take an active part in their recovery."
The PhysioStim devices come in different models and are designed to
anatomically fit the patient's body. Specific applications are for
treatment of nonunion fractures to the arm, hand, wrist, clavicle,
shoulder, hip, thigh, lower leg, ankle or foot. The devices can be worn
over clothing, casts or internal and external surgical fixation devices.
To learn more, please visit bonegrowththerapy.com.
Orthofix invites those attending the AAOS Annual Meeting to visit Booth
#2351, Hall D to learn more about our next-generation bone growth
A leader in the bone growth stimulation market, Orthofix is dedicated to
expanding indications for the use of PEMF devices. The Company is
currently conducting three investigational device exemption (IDE)
clinical trials to collect safety and effectiveness data of the
Physio-Stim™ system for osteoarthritis of the knee, the RCStim™
system as an adjunctive treatment to surgical repair of full thickness
rotator cuff tears and the Cervical-Stim™ system for treating
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 musculoskeletal 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, 2017, 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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20180307005078/en/
Orthofix International N.V.
Denise Landry, 214-937-2529
Source: Orthofix International N.V.
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