NanoVibronix Reports Successful Trial Results for Use of PainShield™ in Patients with Trigeminal Neuralgia; Reinforces Pote...
July 24 2018 - 7:30AM
NanoVibronix, Inc, (NASDAQ:NAOV), a medical device
company utilizing the Company's proprietary and patented low
intensity surface acoustic wave (SAW) technology, today announced
successful results for its PainShield™ device in treating patients
with Trigeminal Neuralgia. PainShield™ is an ultrasound-based
product that is designed to treat pain in nerves, muscles, joints
and soft tissue through delivery of a localized ultrasound, and
induces soft tissue healing in targeted areas. PainShield™
has received 510(k) clearance from the U.S. Food and Drug
Administration, CE Mark approval in Europe, and Health Canada
approval. PainShield™ is available online at
www.nanovibronix.com and through select distributors.
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 US
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 which 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 control
group saw an improvement in baseline scores of 2.3% versus the
treatment group, which saw a 55.2% improvement in baseline scores.
Additionally, the control group saw a reduction in breakthrough
pain medication of 1.5% versus the treatment group, which saw a
46.4% reduction in breakthrough pain medication. In addition
to measurable differences in all aforementioned measurement
categories, there was a general improvement in uninterrupted sleep.
The Company plans to have the final comprehensive data submitted
for publication in a leading industry journal.
Brian Murphy, Chief Executive Officer of
NanoVibronix Inc., commented, “We are very pleased to report the
final results of our PainShield™ study for patients with Trigeminal
Neuralgia. We saw a dramatic improvement in both pain scores
and the use of pain medications such as opioids. We look
forward to having these results published in a leading medical
journal and aggressively marketing the device to physicians in
order to help the millions of patients worldwide suffering from
this painful and debilitating condition. Given the current
opioid crisis, the fact we can help reduce dependence on
medications, will also help save lives. This was a very
challenging patient population and we look forward to conducting
similar studies, where we believe we can replicate our success for
other painful conditions.”
About NanoVibronix
NanoVibronix Inc. (NASDAQ:NAOV) is a medical
device company headquartered in Elmsford, NY with research and
development in Nesher, Israel, that is focused on developing
medical devices utilizing its proprietary and patented low
intensity surface acoustic wave 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.
SAFE HARBOR STATEMENT: This release contains certain statements
that are, or may be deemed to be, forward-looking statements within
the meaning of section 27A of the Securities Act of 1933 and
section 21E of the Securities Exchange Act of 1934, and are made in
reliance upon the protections provided by such Acts for
forward-looking statements. We have identified forward-looking
statements by using words such as "expect," "believe," and
"should." Although we believe our expectations are reasonable, our
operations involve a number of risks and uncertainties that are
beyond our control, and these statements may turn out not to be
true. Risk factors associated with our business, including some of
the facts set forth herein, are detailed in the Company's Form SEC
filings.
Investor Contacts:Crescendo
Communications naov@crescendo-ir.com212-671-1021
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