NanoVibronix Advances Efforts to Achieve NHS Approval

Rhea-AI Summary

NanoVibronix, Inc. (NASDAQ: NAOV) has received positive guidance from the National Institute for Health and Care Excellence (NICE) regarding its UroShield® device. The guidance highlights UroShield's potential to prevent catheter-associated urinary tract infections (UTIs), suggesting further UK-based research to confirm its benefits. NICE's cost analysis indicates that UroShield could save costs in healthcare settings, warranting its use among NHS patients. This publication is a crucial step toward achieving NHS approval for UroShield's wider application.

Positive

• NICE guidance indicates UroShield has potential benefits for preventing catheter-associated UTIs.
• NICE suggests UroShield may be cost-saving in hospital and community care settings.
• Publication of NICE recommendations is a step toward potential NHS approval for UroShield.

Negative

• None.

UroShield Receives Positive Guidance from NHS

ELMSFORD, N.Y.--(BUSINESS WIRE)-- NanoVibronix, Inc. (NASDAQ: NAOV), a medical device company that produces the UroShield® and PainShield® Surface Acoustic Wave (SAW) Portable Ultrasonic Therapeutic Devices, today announced that it has received the publication of Guidance from the National Institute for Health and Care Excellence (NICE) with recommendations of the company’s UroShield device.

The Guidance states that UroShield has the potential to provide significant patient and healthcare system benefits in preventing catheter associated urinary tract infections (UTIs) with further UK-based research recommended to confirm the positive results shown for people with long-term catheters and also to determine whether people with short-term catheters would benefit from using UroShield, particularly if they are considered at high risk of infection or have regular catheter blockages.

Encouragingly, NICE also reported that their cost analyses suggest UroShield may be cost saving in hospital and in people with repeated UTIs or catheter blockages in community care, and they recommend the expansion of use by NHS patients so that further real world evidence can be collected.

Publication by NICE of its recommendation for UroShield is an important step towards identifying the specific research required to achieve NHS approval for use by all of its patients at risk of catheter associated urinary tract infections and blockages. NanoVibronix is already engaged with the NICE team who are working with funding bodies to ensure they are aware of the priority of this further research.

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 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220405005386/en/

Investor Contacts:

Brett Maas, Managing Principal, Hayden IR, LLC

brett@haydenir.com

(646) 536-7331

Source: NanoVibronix, Inc.

FAQ

What is the significance of the NICE guidance for UroShield by NanoVibronix?

The NICE guidance suggests that UroShield has the potential to significantly benefit patients by preventing catheter-associated urinary tract infections and supports further research.

How could UroShield impact healthcare costs?

NICE's cost analysis indicates that UroShield may save costs within hospital settings and for individuals with repeated UTIs or catheter blockages in community care.

What are the next steps for UroShield following NICE's recommendations?

Following NICE's recommendations, further research is required to confirm UroShield's effectiveness and safety, which is necessary for NHS approval.

What is NanoVibronix's main product mentioned in the press release?

The main product mentioned in the press release is UroShield®, a device designed to prevent catheter-associated urinary tract infections.

When was the guidance from NICE published?

The guidance from NICE regarding UroShield was published recently, as mentioned in the press release.