NanoVibronix Announces Results from UroShield™ Case Series

UroShield Demonstrates Significant Reductions in CAUTIs, Catheter Blockages and Hospital Visits

TYLER, Texas--(BUSINESS WIRE)-- NanoVibronix, Inc. (NASDAQ: NAOV) (the “Company”), a medical technology company specializing in therapeutic devices, today announced findings from a recent retrospective case series evaluating the clinical impact and patient experience of the UroShield™ system.

The case series, conducted between September 2023 and January 2025 by researchers at University Hospitals Coventry and Warwickshire Partnership NHS, assessed a small group of patients who used the UroShield device for durations ranging from 12 weeks to 17 months. The series reviewed pre- and post-treatment data on catheter-associated urinary tract infections (CAUTIs), catheter blockages, unplanned hospital visits and patient satisfaction.

Key Outcomes of the Case Series Included:

• a 94% average reduction in CAUTIs and catheter blockages;
• a 92% decrease in unplanned hospital visits;
• extended intervals between catheter changes, improving patient comfort and quality of life;
• high patient compliance and satisfaction; and
• only one patient discontinued due to worsening of pre-existing bladder symptoms.

Importantly, these outcomes reinforce the results from previous studies, including those by Markowitz et al. (2018)¹ and Da Silva, Ibbotson, and O’Neil (2021)², which demonstrated the effectiveness of UroShield in reducing infection risk, improving catheter management, and enhancing overall patient outcomes.

“We believe that this case series reinforces the growing body of clinical evidence supporting UroShield as an effective solution for minimizing catheter-associated risks, improving patient care and the quality of life for patients living with long-term catheterization while reducing healthcare burden,” said Brian Murphy, CEO of NanoVibronix, Inc. “The results of this series are another strong affirmation of the device’s value for both patient care and healthcare cost reduction.”

UroShield utilizes proprietary Surface Acoustic Wave (SAW) technology to prevent bacterial colonization and biofilm formation on indwelling urinary catheters, a critical advancement in reducing complications such as CAUTIs.

The case series will be presented on May 19, 2025, at the Association for Continence Professionals annual conference, ACP 2025. For additional information about the conference, please visit https://fitwise.eventsair.com/acp2025/.

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1 Markowitz. S., Rosenblum. J., Goldstein. M., Gadagkar. H.P., and Litman. L. (2018) The effect of surface acoustic waves on bacterial load and preventing catheter-associated urinary tract infections (CAUTI) in long term indwelling catheters

2 Da Silva. K., Ibbotson. A., and O’Neil. M. (2021) The effectiveness of UroShield in reducing urinary tract infections and patients’ pain complaints: Retrospective Data Analysis from Clinical Practice.

About NanoVibronix, Inc.

NanoVibronix, Inc. (NASDAQ: NAOV) is a medical device company headquartered in Tyler, Texas, 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 continuous assistance of medical professionals. The Company’s primary products include PainShield® and UroShield®, which are portable devices suitable for administration at home or in any care setting. 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. These forward-looking statements include, but are not limited to: future expectations and plans and prospects for the Company. 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) market acceptance of the Company’s existing and new products or lengthy product delays in key markets; (ii) negative or unreliable clinical trial results; (iii) inability to secure regulatory approvals for the sale of the Company’s products; (iv) intense competition in the medical device industry from much larger, multinational companies; (v) product liability claims; (vi) product malfunctions; (vii) the Company’s limited manufacturing capabilities and reliance on subcontractor assistance; (viii) insufficient or inadequate reimbursements by governmental and/or other third party payers for the Company’s products; (ix) the Company’s ability to successfully obtain and maintain intellectual property protection covering the Company’s products; (x) legislative or regulatory reform impacting the healthcare system in the U.S. or in foreign jurisdictions; (xi) the Company’s reliance on single suppliers for certain product components, (xii) the need to raise additional capital to meet the Company’s future business requirements and obligations, given the fact that such capital may not be available, or may be costly, dilutive or difficult to obtain; (xiii) the Company’s 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 (xiv) 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, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K. 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

brett@haydenir.com

(646) 536-7331

Source: NanoVibronix, Inc.