Signs Term Sheet for a License and Supply Agreement for Distribution of UroShield

ELMSFORD, N.Y., October 09, 2024--(BUSINESS WIRE)--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 it has signed a non-binding term sheet for a license and supply agreement with APOGEPHA Arzneimittel GmbH ("APOGEPHA"), a German pharmaceutical company, which specializes in the development, marketing, sales and distribution of urology products and services. Pursuant to the term sheet, the Company and APOHEPHA intend to enter into a definitive agreement, pursuant to which, APOHEPHA will distribute UroShield throughout Europe.

Brian Murphy, Chief Executive Officer of the Company commented, "We are thrilled to be taking the next step in adding APOGEPHA as a distributor of UroShield in Europe. APOGEPHA is a recognized leader in the field of urology and is committed to providing modalities for patients with urological conditions. Expanding distribution with leading distributors is a key driver to accelerating sales, and with this potential partnership, we have the potential to harness the strength of APOGEPHA’s large sales and marketing team to promote and sell UroShield in Germany."

Dr. Dirk Pamperin, Chairman of the Management Board of APOGEPHA, commented, "At APOGEPHA, we are committed to offering a wide range of high-quality products and services for patients with urological disorders. After completing our own comprehensive market evaluation of UroShield, we are convinced that UroShield will have the ability to support patients with long-term catheters by significantly reducing their catheter-associated urinary tract infections."

UroShield is an ultrasound-based product that is designed to prevent bacterial colonization and biofilm on indwelling urinary catheters and increase antibiotic efficacy, ultimately reducing the incidence of catheter-associated urinary tract infections ("CAUTI"). UroShield is also intended to decrease pain and discomfort associated with urinary catheter use.

About APOGEPHA Arzneimittel GmbH

Founded in Dresden, Germany, in 1882, APOGEPHA stands for more than 140 years of experience in the pharmaceutical sector. Urological research and product development go back almost as far. The family-owned company is one of the leading German enterprises in urology.

With around 150 committed employees, APOGEPHA is not only a supplier of pharmaceuticals, but also a valued partner to clinicians and the health system.

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.

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Contacts

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