New first-to-market feature aims to facilitate patient compliance and
improve spinal fusion outcomes
LEWISVILLE, Texas--(BUSINESS WIRE)--
Orthofix International N.V. (NASDAQ:OFIX), a diversified, global medical
device company, today announced U.S. Food and Drug Administration (FDA)
and European CE Mark approvals for its next-generation CervicalStim™
and SpinalStim™ bone growth stimulators. These Class III
medical devices use a low-level pulsed electromagnetic field (PEMF)
designed to activate and augment the body's natural healing process,
providing patients with a safe, noninvasive treatment option for
promoting post-operative spinal fusion.
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Next-generation SpinalStim and CervicalStim bone growth stimulators developed by Orthofix. (Photo: Business Wire)
The CervicalStim and SpinalStim systems available in the U.S. will be
accompanied by a new application for mobile devices called Stim onTrack™.
Designed for use with smartphones and other mobile devices, Stim onTrack
provides tools to help patients follow their prescription, including
daily treatment reminders and a device usage calendar. The mobile app
also includes a first-to-market feature that enables physicians to
receive real-time data on how their patients are adhering to their
prescribed treatment protocol. Stim onTrack is free and available
through the iTunes App Store. In addition to the app, the
next-generation bone growth stimulators include patient enhancements
aimed at improving fit, comfort and ease of use.
"With the launch of these new devices, our goal is to redefine the
recovery experience of patients using bone growth stimulation devices
post-operatively for lumbar and cervical fusion surgical procedures,"
said Brad Niemann, President of the Orthofix BioStim strategic business
unit. "We are proud to offer the addition of Stim onTrack to our
CervicalStim and SpinalStim devices as we continue to find ways to
partner with physicians in achieving improved clinical outcomes."
"Patient recovery is often dependent on how well they follow the
prescription for the device," said James Ryaby, Ph.D., Chief Scientific
Officer at Orthofix. "Equipping patients with a mobile app to help them
adhere to their prescription is an excellent addition to this system
while simultaneously enhancing post-surgical care by giving physicians
additional data to help personalize follow-up protocols."
These next-generation devices are the latest in a line of bone growth
stimulator systems that Orthofix first introduced into the market in
1990 (SpinalStim) and 2004 (CervicalStim). With a 92 percent clinical
success rate when used adjunctively to spinal fusion surgery, the
SpinalStim device is the only bone growth therapy device approved by the
FDA as both a lumbar spinal fusion adjunct and as a non-surgical
treatment for spinal pseudarthrosis. The CervicalStim device has an
over-all clinical success rate of 84 percent and is the only bone growth
therapy device approved by the FDA as a noninvasive, adjunctive
treatment option for cervical fusion in high risk patients. Together,
these devices are the number one prescribed bone growth stimulators for
Recently the North American Spine Society (NASS) issued
recommendations for electrical bone growth stimulators. These
evidence-based coverage policy recommendations support the use of PEMF
stimulation devices as an adjunct to spinal fusion surgery.
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 two investigational device exemption (IDE) clinical
trials to collect safety and effectiveness data of the CervicalStim
system for treating odontoid fractures and the Physio-Stim system for
osteoarthritis of the knee.
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,
risks relating to: practices of health insurance companies and other
third-party payors with respect to reimbursement for our PEMF devices;
any future changes to the coverage determinations of NASS for electrical
bone growth stimulators; and other risks described in the "Risk Factors"
section of our Annual Report on Form 10-K for the fiscal year ended
December 31, 2015, 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/20170109005213/en/
Mark Quick, 214-937-2924
Denise Landry, 214-937-2529
Source: Orthofix International N.V.
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