LEWISVILLE, Texas--(BUSINESS WIRE)--
Orthofix International N.V. (NASDAQ:OFIX), a diversified, global medical
device company, is pleased to announce the North American Spine Society
(NASS) has issued first-of-its-kind coverage recommendations for
electrical bone growth stimulators. These evidence-based coverage policy
recommendations support the use of pulsed electromagnetic field (PEMF)
stimulation devices as an adjunct to spinal fusion surgery.
Dr. Richard Guyer, orthopedic spine surgeon, co-founder and director at
the Texas Back Institute in Dallas said, "Bone growth stimulation
devices are an important option for patients with risk factors that
might inhibit the success of their spinal fusion procedures. By
stimulating bone growth, we can often avoid the need for revision
The just-issued NASS coverage policy recommends the use of electrical
stimulation for spinal fusion healing in all regions of the spine
including cervical and lumbar regions. Orthofix is the only company with
a bone growth (osteogenesis) stimulator approved by the U.S. Food and
Drug Administration (FDA) as a noninvasive, adjunctive treatment option
for cervical fusion.
"We are pleased that NASS has chosen to proactively examine the medical
evidence and recommend electrical bone growth stimulation devices in
order to assist payors, surgeons and patients by defining appropriate
use and coverage positions," said Brad Niemann, President of the
Orthofix BioStim strategic business unit. "This policy is important as
it further validates the use of bone growth stimulators like the
Orthofix CervicalStim and SpinalStim systems, for
improving spinal fusion outcomes in patients at risk of a failed fusion."
The Orthofix CervicalStim™ and SpinalStim™ devices
use a low-level pulsed electromagnetic field that helps activate and
augment the body's natural healing process. These devices provide
patients with a safe, noninvasive treatment option for promoting spinal
Orthofix invites those attending NASS
2016 to visit Booth #615 to learn more about the Company's BioStim
devices and the coverage recommendations.
The North American Spine Society (NASS) is comprised of more than 8,000
members from several disciplines, including orthopedic surgery,
neurosurgery, physiatry, neurology, radiology, anesthesiology, research
and physical therapy. As part of its mission to foster the highest
quality, evidence-based and ethical spine care, NASS develops credible
and reasonable coverage
recommendations to assist payors, providers, and patients in
defining appropriate and fair coverage decisions. NASS evidence-based
coverage recommendations are developed to advocate for NASS' positions
on various clinical and practice issues to ensure continued provision of
quality spine care.
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/20161024005272/en/
Orthofix International N.V.
Denise Landry, 214-937-2529
Source: Orthofix International N.V.
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