- 70% of patients using PainShield experienced complete resolution or significant improvement in symptoms without
the use of opioids
- PainShield had no adverse events or complications and was deemed both safe and
effective
ELMSFORD, NY / ACCESSWIRE / March 7, 2019 / NanoVibronix, Inc, (NASDAQ: NAOV), a medical device company
utilizing the Company's proprietary and patented low intensity surface acoustic wave (SAW) technology, today announced results of a
study entitled, "The Effects of the NanoVibronix's PainShield® Surface Acoustic Waves on the Symptoms of Lateral Epicondylitis."
The clinical study was conducted by Dr. David Lemak, a leading orthopedic surgeon with Birmingham Orthopedic and Sports
Specialists.
The trial was a randomized, double blinded study for 30 days that evaluated the effectiveness and safety of PainShield™ Surface
Acoustic Wave (SAW) technology on patients suffering from pain and discomfort, as well as limited mobility caused by the effects of
chronic or acute lateral epicondylitis (LE) ("tennis elbow"). A total of 24 patients were enrolled, half of whom were treated with
the PainShield™ device plus physical therapy and the other half were treated with a placebo device plus physical therapy. Two of
the patients did not complete the trial. Patients were not allowed to use opioids during the trial, nor were they allowed to have
any type of injections (cortisone or any other) at any time during the study or within the last 30 days. Patients were allowed to
take standard over-the-counter anti-inflammatory medication such as ibuprofen.
While the study is ongoing with additional patients enrolling, based on the initial results, seven out of ten patients (70.0%)
who completed the study using PainShield plus physical therapy had complete resolution or significant improvement in pain. Among
the placebo group plus physical therapy, five out of twelve patients (41.7%) experienced complete resolution or significant
improvement in pain. Upon completion of the trial, the Company will have full results, which it expects to publish later this
year.
Tennis elbow is a painful condition due to inflammation of the tendons that join the forearm muscles to the outside of the
elbow, which become damaged from overuse. PainShield is a wearable, battery powered electronic unit that delivers localized
therapeutic ultrasound to relieve pain and induce soft tissue healing. PainShield can be easily utilized by patients from the
convenience of home or in healthcare facilities.
Brian Murphy, Chief Executive Officer of NanoVibronix, commented, "We are pleased to report the initial results of this study,
which saw a significant improvement in reported pain among patients using PainShield™ versus the placebo device. PainShield had no
adverse events or complications and was deemed safe and effective in treating patients with tennis elbow. This is important,
because we are not aware of any other clinically proven treatment for tennis elbow. To date, the PainShield™ device and our SAW
technology has been used both commercially and in clinical trials and there have been no reported adverse events. We believe this
study further validates that PainShield represents an effective alternative to opioids."
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 PainShieldÔ, UroShieldÔ and WoundShieldÔ. 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 Waldman
Crescendo Communications
naov@crescendo-ir.com
212-671-1021
SOURCE: NanoVibronix, Inc
