NanoVibronix Announces Publication of PainShield™ Trigeminal Neuralgia Study in the Journal of Anesthesiology and Pain Rese...
February 25 2019 - 8:00AM
55.2% improvement in baseline pain scores
versus 2.3% for the control group
NanoVibronix, Inc., (NASDAQ: NAOV), a medical
device company utilizing the Company's proprietary and patented low
intensity surface acoustic wave (SAW) technology, today announced
the publication of an independent study entitled, “The Effect of a
Surface Acoustic Wave (SAW) Device on the Symptomatology of
Trigeminal Neuralgia,” which was published in the January 2019
issue of Journal of Anesthesiology and Pain Research, a leading
peer-reviewed journal in the field of anesthesiology. The study
publication is available at:
https://www.omicsonline.org/open-access/the-effect-of-surface-acoustic-wave-saw-device-on-the-of-trigeminal-neuralgia.pdf.
Trigeminal Neuralgia, also known as Prosopalgia,
‘suicide disease,’ or Fothergill’s disease is a neuropathic
disorder characterized by episodes of intense pain in the face,
originating from the trigeminal nerve. Trigeminal Neuralgia is
considered one of, if not the most, chronically painful conditions,
and is associated with a high suicide rate directly attributable to
the condition. Trigeminal Neuralgia is pain that spreads over
the face and down the neck. As many as 280,000 individuals in the
U.S. and 7 million worldwide are estimated to suffer from the
condition. Current treatments are limited to medications such as
opioids and surgical interventions, which have a high rate of
recurrence.
The double blinded, crossover trial was
conducted across the U.S. and included 59 patients with a diagnosis
of Unilateral Trigeminal Neuralgia. Among the 59 patients, 30 were
in the active treatment group and 29 were in the control
group. The values that were assessed include Visual Analog
Scale (VAS) pain score, both baseline prior to trial and VAS pain
score at the end of the study. The study also assessed
breakthrough medications per week at the start of the trial and
breakthrough medications per week at the end of the trial, with a
particular focus on the use of opioids. Breakthrough
medications are used for chronic pain directly related to the
pre-existing Trigeminal Neuralgia condition.
There was a significant difference in the
outcomes of the two groups relative to pain, quality of life, and
breakthrough medications taken, which was directly correlated to
pain experienced during treatment. Specifically, the
treatment group experienced a 55.2% improvement in baseline pain
scores versus 2.3% for the control group. The treatment group
experienced a 46.4% reduction in breakthrough pain medication
versus 1.5% for the control group. In addition to measurable
differences in all aforementioned measurement categories, there was
a general improvement in uninterrupted sleep.
Brian Murphy, Chief Executive Officer of
NanoVibronix, commented, “This publication is a major independent
validation of the PainShield™ device. This was a very challenging
patient population and we were pleased to see a dramatic
improvement in both pain scores and the reduced use of pain
medications such as opioids. Given the current opioid crisis,
the fact we can help reduce dependence on medications, may also
help save lives. Now that this study is published in a
prestigious peer reviewed scientific journal, we will be
aggressively marketing the device to physicians in order to help
the millions of patients worldwide suffering from this painful and
debilitating condition. We also believe we can replicate our
success for other painful conditions.”
About NanoVibronix
NanoVibronix, Inc. (NASDAQ: NAOV) is a medical
device company headquartered in Elmsford, New York with research
and development in Nesher, Israel, that is focused on developing
medical devices utilizing its proprietary and patented low
intensity surface acoustic wave (SAW) technology. The company’s
technology allows for the creation of low-frequency ultrasound
waves that can be utilized for a variety of medical applications,
including the disruption of biofilms and bacteria colonization, as
well as providing pain relief. The devices can be administered at
home, without the assistance of medical professionals. The
company’s primary products include PainShield™, UroShield™ and
WoundShield™. Additional information about the company is available
at: www.nanovibronix.com.
Forward-looking Statements
This press release contains “forward-looking
statements.” Such statements may be preceded by the words
“intends,” “may,” “will,” “plans,” “expects,” “anticipates,”
“projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,”
“potential” or similar words. Forward-looking statements are not
guarantees of future performance, are based on certain assumptions
and are subject to various known and unknown risks and
uncertainties, many of which are beyond the Company’s control, and
cannot be predicted or quantified and consequently, actual results
may differ materially from those expressed or implied by such
forward-looking statements. Such risks and uncertainties include,
without limitation, risks and uncertainties associated with (i)
market acceptance of our existing and new products, (ii) negative
clinical trial results or lengthy product delays in key markets,
(iii) an inability to secure regulatory approvals for the sale of
our products, (iv) intense competition in the medical device
industry from much larger, multinational companies, (v) product
liability claims, (vi) product malfunctions, (vii) our limited
manufacturing capabilities and reliance on subcontractors for
assistance, (viii) insufficient or inadequate reimbursement by
governmental and other third party payers for our products, (ix)
our efforts to successfully obtain and maintain intellectual
property protection covering our products, which may not be
successful, (x) legislative or regulatory reform of the healthcare
system in both the U.S. and foreign jurisdictions, (xi) our
reliance on single suppliers for certain product components, (xii)
the fact that we will need to raise additional capital to meet our
business requirements in the future and that such capital raising
may be costly, dilutive or difficult to obtain and (xiii) the fact
that we conduct business in multiple foreign jurisdictions,
exposing us to foreign currency exchange rate fluctuations,
logistical and communications challenges, burdens and costs of
compliance with foreign laws and political and economic instability
in each jurisdiction. More detailed information about the Company
and the risk factors that may affect the realization of forward
looking statements is set forth in the Company’s filings with the
Securities and Exchange Commission (SEC), including the Company’s
Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q.
Investors and security holders are urged to read these documents
free of charge on the SEC’s web site at http://www.sec.gov. The
Company assumes no obligation to publicly update or revise its
forward-looking statements as a result of new information, future
events or otherwise.
Investor Contact
David WaldmanCrescendo
Communicationsnaov@crescendo-ir.com212-671-1021
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