NanoVibronix Reports Schedule Published by NICE for Review of UroShield® Device
Provides Milestones for Attaining NICE Guidance, Including Addition of UroShield to the NHS Supply Chain; Process Completion and Recommendation Expected in Q1 2022
ELMSFORD, N.Y.--(BUSINESS WIRE)--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 that it has received documentation from the National Institute for Health and Care Excellence (NICE) that outlines the timeline for NICE’s review and recommendation of the company’s UroShield device.
Publication of the approval schedule and timeline more clearly codifies the process that the company believes will ultimately lead to a positive recommendation of the device by NICE adoption by the National Health Service (NHS) as a clinically effective and cost saving medical device and addition of the device to the NHS Supply Chain Catalogue. As an important element of this approval, funding may also be provided by the NHS through the Medtech Funding Mandate, demonstrating the NHS commitment to accelerate the uptake of NICE-approved, cost-saving medical devices throughout the health system, meaning patients will get access to these technologies faster.
“Publication by NICE of its schedule for the review of the independent study and its recommendation for UroShield is an important step towards attaining ‘official guidance’ and ultimately achieving adoption by NHS for use by all of its patients at risk of catheter associated urinary tract infections,” stated Brian Murphy, CEO of NanoVibronix. “Findings from the recent independent study demonstrate statistically significant benefits and positive outcomes from patients that use the medical device. We remain committed to full commercialization of UroShield and are encouraged by NICE’s addition of the study to its evidence-based medicine documentation.”
The date for publication for rollout to the NHS is March, 2022, coinciding with the NHS financial year, which begins on April 1st and details of the UroShield review process are made available online by NICE at https://www.nice.org.uk/guidance/indevelopment/gid-mt560.
“NICE has achieved wide international impact, leading the way for more evidence-based value assessment of medicines and medical devices,” continued Murphy. “The NICE process for review, recommendation and approval has helped global health systems and clinicians to focus the practice of medicine where it matters most from both a quality of patient care and cost effectiveness perspective.”
As previously announced, the company submitted to NICE for review, the findings from an independent evaluation of its UroShield® device on patients who had used the device for up to two years.. Clinical data from the study, conducted by Coventry University’s Assistant Professor, Ksenija Maravic da Silva, reported statistically significant outcomes for the device including 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. 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.
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.
Brett Maas, Managing Principal, Hayden IR, LLC