SOURCE: NanoVibronix, Inc.

NanoVibronix, Inc.

December 14, 2017 07:30 ET

NanoVibronix Announces IMS Ultrasound (UK) Ltd as its Exclusive UK Distributor for UroShield™ Following Successful Interim Trial Results

UroShield™ Designed to Save Lives Due to High Rate of Catheter-Associated Urinary Tract Infections in the UK

IMS Ultrasound Agrees to Fund Additional Clinical Study with UK's National Health Service

ELMSFORD, NY--(Marketwired - December 14, 2017) - NanoVibronix, Inc., (NASDAQ: NAOV), a medical device company utilizing the Company's proprietary and patented low intensity surface acoustic wave (SAW) technology, today announced it has signed IMS Ultrasound (UK) Ltd as its exclusive distributor for UroShield™ in the United Kingdom. IMS Ultrasound is a wholly owned subsidiary of IMS (International Medical Supplies) Euro, a leading international supplier of medical products. The Company also announced that IMS Ultrasound (UK) Ltd has agreed to fund an additional clinical study with the United Kingdom's National Health Service (NHS) to further support its marketing initiatives.

UroShield™ is an ultrasound-based product that is designed to prevent bacterial colonization and biofilm on indwelling urinary catheters and increase antibiotic efficacy, ultimately reducing the incidence of catheter-associated urinary tract infections (CAUTI). UroShield is also intended to decrease pain and discomfort associated with urinary catheter use.

CAUTI is the second most common cause of hospital-acquired infection and an estimated 15-25% of patients admitted to NHS hospitals in the United Kingdom each year will require urethral catheterization with a risk of developing bacteriuria of up to 5% per day. Development of CAUTI is estimated to prolong a patient's hospital stay by up to 5 days and is associated with a significant increase in patient mortality.

Andrew Wakeling, Managing Director of IMS Ultrasound (UK) Ltd, commented, "CAUTI is a major health concern in the UK and around the world, leading to extended hospital stays, increased costs, as well as increased patient mortality. We are excited to partner with NanoVibronix in order to bring UroShield to market in the UK, which we believe has enormous potential and could help save many lives. Given the strong supporting clinical data to date, we look forward to conducting an additional clinical trial in the UK with the support of NHS, which we believe will help garner even greater support from payors."

Brian Murphy, Chief Executive Officer of NanoVibronix Inc., commented, "We are excited to report the addition of a significant European distributor partnership for UroShield following our recently announced preliminary clinical results, which demonstrate a material reduction in the rate of CAUTI. UroShield already has European marketing clearance, and this latest data is now helping us to attract the leading distributors across Europe. The fact IMS Ultrasound is willing to fully fund the planned clinical trial in the UK is strong validation of their interest and commitment to our UroShield product."

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.

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..

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