NanoVibronix Enters into Letter of Intent with APOGEPHA Arzneimittel GmbH to Explore European Distribution Opportunity

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Independent Urology Company to Study the Potential for UroShield Distribution in Germany and other European Markets

ELMSFORD, N.Y., December 04, 2023--(BUSINESS WIRE)--NanoVibronix, Inc. (NASDAQ: NAOV), a medical device company that produces the UroShield®, PainShield® and WoundShield® Surface Acoustic Wave (SAW) Portable Ultrasonic Therapeutic Devices, today announced that it has entered into a non-binding letter of intent (the "LOI") with APOGEPHA Arzneimittel GmbH ("APOGEPHA") in which both parties will analyze the potential for APOGEPHA to distribute NanoVibronix’s premiere UroShield product in Germany and other European markets.

With a history that dates back over 100 years, APOGEPHA has established itself as a high quality, dedicated specialist in the field of urology. Under the terms of the LOI, APOGEPHA will commence a comprehensive market evaluation on how UroShield fits into the pathway of care for patients with long term catheters. The goal of the LOI, and subsequent findings, will be for both NanoVibronix and APOGEPHA to better understand the feasibility of a distribution deal between both companies.

Brian Murphy, Chief Executive Officer of NanoVibronix, Inc., said, "APOGEPHA’s impeccable reputation in the field of urology coupled with their intimate knowledge of market access, reimbursement strategies and speed to market decisions, gives us great optimism about UroShield’s potential for success in Europe and APOGEPHA’s pivotal role in its distribution. As a solution for patients who are poorly served though the traditional pharmaceutical route of simple antibiotics, UroShield has the potential to become a true standard of care in Europe, and we look forward to working with APOGEPHA to fully understand and model this opportunity."

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 devices can be administered at home without the assistance of medical professionals. 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) 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20231204777964/en/

Contacts

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

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