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Findings Submitted to National Institute for Health and Care Excellence (NICE)
Physical and Mental Benefits of UroShield Documented in Two-Year, Real-World Evaluation
NanoVibronix, Inc., (NASDAQ: NAOV), a medical device company that produces the UroShield®, PainShield® and WoundShield® Surface Acoustic Wave (SAW) Portable Ultrasonic Therapeutic Devices, today announced positive findings from an independent evaluation of its UroShield® device on patients who have used the device for up to two years. The results have been submitted to the National Institute for Health and Care Excellence (NICE) for review and consideration.
"Findings from an independent study demonstrate significant benefits of our UroShield device with patients reporting reductions in blockages, catheter changes and use of bladder maintenance solutions in addition to reductions in pain, fewer visits to clinics and hospitals for emergency catheter changes," stated Brian Murphy, CEO of NanoVibronix. "As part of our ongoing engagement, we submitted these findings to NICE as part of the process for attaining ‘official guidance’ from the organization, an important step in providing access to all NHS patients at risk of catheter associated urinary tract infections. We believe that these findings should also reinforce our efforts in the U.S. and other target markets."
An independent statistical analysis conducted by Coventry University’s Assistant Professor, Ksenija Maravic da Silva, reported statistically significant outcomes for the company’s UroShield device. The findings demonstrated a reduced number of urinary tract infections (UTIs), reduced instances of prescribed antibiotics, reduced catheter blockages, reduced the need for unplanned catheter changes and reduced pain reported as a result of catheter associated complications. In addition, the study also provided important insights into the lives of those using the device including improvement of overall well-being, relating specifically to decreased levels of worry and increased ability to socialize. In addition, patient feedback on product improvements were addressed and have been incorporated in the present commercially available device.
"Tangentially, patients also reported an overall improvement in their mental state, which was described as ‘priceless’ and ‘life changing’ by study participants and their loved ones," added Murphy. "Beyond the physical health benefits, patients cited improved sleep, higher levels of energy, increased confidence and desire to socialize with family and friends. We remain committed to full commercialization of our products, and the real-world findings and testimonials from this study further substantiate what we already know to be true about the efficacy of UroShield."
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®, UroShield® and WoundShield®, all of which are portable devices suitable for administration at home without assistance of medical professionals. Additional information about NanoVibronix is available at: www.nanovibronix.com.
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, e.g., 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.
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Brett Maas, Managing Principal, Hayden IR, LLC