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 provided an update on recent business developments.

Brian Murphy, Chief Executive Officer of NanoVibronix, Inc., commented, “We have made substantial progress over the last several months with regards to expanding distribution, raising commercial awareness and pursuing reimbursements from regulatory authorities. Our products continue to deliver impressive results with high patient satisfaction and importantly, we believe are positioned to fill a void in the market. We are highly optimistic about the prospects for our business given the success we are having towards increasing market penetration.”

Expanding Distribution

Expanding distribution of the Company’s products with leading distributors is a key driver to accelerating market adoption of UroShield. Following substantial interest from clinicians in South Africa, the Company has signed a letter of intent with Kriel Technology Group (Pty) Ltd (“KrielTech”), to explore opportunities for distribution of the Company’s UroShield device in South Africa. KrielTech will conduct a market evaluation early next year to better understand the market opportunity. Given the broadening acceptance of UroShield, the Company is optimistic about reaching a distribution agreement with KrielTech and the opportunities to enter this new market with it as a partner.

Leveraging Independent Research to Increase Product Awareness

Catheter-associated urinary tract infections (CAUTIs) continue to be a major concern in healthcare settings, particularly for patients who require long-term catheterization. Research has explored the use and effectiveness of the Company’s UroShield in a number of settings and circumstances. Time and again, UroShield has been proven effective in reducing the incidence of CAUTI.

Independent studies of UroShield were recently presented at major medical conferences including the International Continence Society (“ICS”) in Madrid and the British Association of Urological Nurses (“BAUN”) in the United Kingdom. At ICS, a study on spinal injury patients was presented that concluded, “This device provides a solution to the problem of recurrent infection and catheter blockages, improving the quality of life for spinal injury patients.” At BAUN, clinicians presented real world patient studies that demonstrated both the clinical effectiveness of the device and the economic benefits to the health system.

In New Zealand, where UroShield now has insurance coverage, an independent study of UroShield regarding the effectiveness of UroShield is scheduled to be published in the Australian and New Zealand Continence Journal in December 2024.

Pursuing Additional Reimbursements

The Company’s application for UroShield actuators to be available on NHS Prescription Services’ Drug Tariff was approved for reimbursement in 2023. Following this success, in July of this year, the Company submitted a request for full reimbursement of UroShield for all NHS patients and is currently awaiting a response from NHS.

In Germany, the Company’s submission for full reimbursement for UroShield was recently completed and the product indications are:

  • Reduction of urinary tract infections due to biofilm formation
  • Avoiding blockage of the catheter
  • Avoidance or relief of pain, discomfort and spasms

The Company is awaiting response from GKV-SV German health reimbursement authority, which could be as soon as January 2025.

Murphy concluded, “We are committed to our strategic vision of developing, improving and commercializing our distinct and effective therapies. The areas we are focusing on are showing positive results. We are making measurable progress towards expanding distribution globally and increasing awareness among healthcare and insurance providers and government regulators.”

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.

Investor Contact:

Brett Maas, Managing Principal, Hayden IR, LLC brett@haydenir.com (646) 536-7331

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