NanoVibronix Advances Development of PainShield and UroShield with Completion of NextGen Prototypes

ELMSFORD, N.Y. – NanoVibronix, Inc. (NASDAQ: NAOV) (the “Company”), a medical device company that produces the UroShield®, PainShield® and WoundShield® Surface Acoustic Wave (SAW) Portable Ultrasonic Therapeutic Devices, today announced a third-party contractor engaged by the Company has completed the design phase for the development of the Company’s next generation PainShield® and UroShield® devices.

During the design phase, which was completed in December 2024, the third-party contractor developed prototypes of the Company’s next generation PainShield® and UroShield® devices that aim to reduce both the cost of assembly and the risk profile and minimize user burden.

Brian Murphy, Chief Executive Officer of the Company, commented, “We are pleased with the work the development team completed during the design phase. The prototypes were delivered on-time and within budget, and we are now eager to move forward to the next phase for further validation and testing. We are continuously seeking opportunities to advance our products, drive operational improvements in our business and evolve our products for the benefit of the patients who use them. Completion of this phase represents a major milestone towards our ultimate goal of broader adoption by the healthcare community of PainShield and UroShield and increasing unit sales.”

Design Updates Include:

• Additional mode of therapy to enhance the user experience and improve efficacy.
• Future-Proofing and Optimization of Componentry: The design has been updated to ensure that its current components will remain readily available throughout the manufacturing and commercialization process.
• Streamlining the Software: Efforts have been made to simplify and optimize the software for better performance and ease of use.
• Enhancements to the User Interface: The actuator cable has been redesigned to feature USB-C connectors, and a single lead will now be used for the UroShield® model, enhancing user experience and simplifying device setup.
• Improvements to design to promote cost effective production and regulatory compliance.

The Company is moving to the next phase of development, which will involve further validation and testing based on feedback and protocols the Company has received to date.

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. 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 our 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 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 subcontractor assistance; (viii) insufficient or inadequate reimbursements by governmental and/or other third party payers for our products; (ix) our ability to successfully obtain and maintain intellectual property protection covering our products; (x) legislative or regulatory reform impacting the healthcare system in the U.S. or in foreign jurisdictions; (xi) our reliance on single suppliers for certain product components, (xii) 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; (xiii) 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 (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 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.