NANOVIBRONIX ANNOUNCES POSITIVE RESULTS FROM INDEPENENT, DOUBLE-BLIND TRIAL OF PAINSHIELD
October 11 2021 - 9:06AM
NanoVibronix, Inc., (NASDAQ: NAOV), a healthcare device company
that produces the UroShield® and PainShield® Surface Acoustic
Wave (SAW) Portable Ultrasonic Therapeutic Devices, today announced
positive results from a randomized, double-blind study conducted at
Birmingham Orthopedic and Sports Specialists in Birmingham,
Alabama.
Clinicians at Birmingham Orthopedic and Sports Specialists
recently conducted a randomized, double-blind study to evaluate the
safety and effectiveness of the NanoVibronix PainShield. Patients
in the study were being treated by an orthopedic surgeon for
lateral epicondylitis, more commonly known as tennis elbow, a
swelling or tearing of the tendons in the arm. It is characterized
by a pain or ache on the outside of the arm where the forearm meets
the elbow. All patients in the study had symptoms of pain and point
tenderness at the beginning of the study and had been following
customary treatment guidance, which failed to provide pain relief.
Conversely, at the conclusion of the study, 91% of the patients in
the PainShield treatment group had complete or partial resolution
of symptoms. Patients used PainShield in conjunction with
over-the-counter medication, as needed, but without the benefit of
opioid-based prescription medication.
Brian Murphy, CEO of Nanovibronix, stated, “Results of the
Birmingham study further reinforce that PainShield is safe,
easy-to-use and highly effective in treating soft tissue pain.
Patients in the study who wore our device reported marked reduction
in pain and when combined with over-the-counter, anti-inflammatory
medications, those same patients reported a complete resolution of
symptoms within 10 days.”
Dr. David Lemak, MD, Lead Investigator of the Birmingham Study,
added, “Patient outcomes were markedly improved with the use of
PainShield and importantly, no patients returned with signs or
symptoms of an exacerbation. Most encouraging are the results we
were able to achieve for our patients without the use of
prescription opioid medications, which can often lead to prolonged
use and addiction.”
Full details of the study and its findings are available at
nanovibronix.com.
PainShield is an ultrasound device that delivers a localized
ultrasound effect to treat pain and induce soft tissue healing in a
targeted area, while keeping the level of ultrasound energy at a
safe and consistent level. Its range of applications includes acute
and chronic pain resolution through its many mechanisms of action.
The product has broad applications for sports injuries. PainShield
can be used by patients at home or work or in a clinical setting
and can be used even while the patient is sleeping. Patient
benefits include ease of application and use, faster recovery time,
high compliance, and increased safety and efficacy over existing
devices that rely on higher-frequency ultrasound.
About NanoVibronix, Inc.
NanoVibronix, Inc. (NASDAQ: NAOV) is a medical device company
headquartered in Elmsford, New York, with research and development
in Nesher, Israel, focused on developing medical devices utilizing
its patented low intensity surface acoustic wave (SAW) technology.
The proprietary technology allows for the creation of low-frequency
ultrasound waves that can be utilized for a variety of medical
applications, including for disruption of biofilms and bacterial
colonization, as well as for pain relief. The devices can be
administered at home without the assistance of medical
professionals. The Company’s primary products include PainShield®
and UroShield®, which are portable devices suitable for
administration at home without assistance of medical professionals.
Additional information about NanoVibronix 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; 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) the geographic, social and
economic impact of COVID-19 on the Company’s ability to conduct its
business and raise capital in the future when needed, (ii) market
acceptance of our existing and new products or lengthy product
delays in key markets; (iii) negative or unreliable clinical trial
results; (iv) inability to secure regulatory approvals for the sale
of our products; (v) intense competition in the medical device
industry from much larger, multinational companies; (vi) product
liability claims; (vii) product malfunctions; (viii) our limited
manufacturing capabilities and reliance on subcontractor
assistance; (ix) insufficient or inadequate reimbursements by
governmental and/or other third party payers for our products; (x)
our ability to successfully obtain and maintain intellectual
property protection covering our products; (xi) legislative or
regulatory reform impacting the healthcare system in the U.S. or in
foreign jurisdictions; (xii) our reliance on single suppliers for
certain product components, (xiii) the need to raise additional
capital to meet our future business requirements and obligations,
given the fact that such capital may not be available, or may be
costly, dilutive or difficult to obtain; (xiv) our conducting
business in foreign jurisdictions exposing us to additional
challenges, such as foreign currency exchange rate fluctuations,
logistical and communications challenges, the burden and cost of
compliance with foreign laws, and political and/or economic
instabilities in specific jurisdictions; and (xv) market and other
conditions. 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, except as required by law.
Brett Maas, Managing Principal
Hayden IR, LLC
646-536-7331
brett@haydenir.com
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