NanoVibronix Announces PainGuard and UroGuard Approved by Health Canada as Licensed Medical Devices

Rhea-AI Summary

NanoVibronix (NASDAQ: NAOV) announced the approval of its PainGuard and UroGuard products as licensed medical devices by Health Canada. This license enables Ideal Medical International Limited to market these products in Canada, enhancing NanoVibronix's distribution capabilities. The CEO highlighted the opportunity for growth, particularly addressing chronic pain affecting nearly one in four Canadians. The press release emphasizes the potential for the company's products to provide safer alternatives to opioids and reduce infections from urinary catheters.

Positive

• Approval of PainGuard and UroGuard by Health Canada enhances market opportunities.
• Strategic partnership with Ideal Medical for distribution in Canada.
• Addresses significant healthcare needs in Canada with potential for growth.

Negative

• None.

Increases Opportunity for Broader International Distribution

ELMSFORD, N.Y.--(BUSINESS WIRE)-- NanoVibronix, Inc., (NASDAQ: NAOV), a medical device company that produces the UroShield® and PainShield® Surface Acoustic Wave (SAW) Portable Ultrasonic Therapeutic Devices, today announced the Company’s PainGuard and UroGuard, offered as private label products through Ideal Medical International Limited, have been approved by Health Canada / Santé Canada as licensed medical devices.

The license issued by Health Canada allows Ideal Medical International Limited (“Ideal Medical”), one of the Company’s international distribution partners, to market and sell the Company’s PainGuard and UroGuard as licensed medical devices in Canada.

“This license clears the way for our distribution partner, Ideal Medical, to accelerate distribution of our products in Canada, another catalyst for our potential future growth and international expansion,” said Brian Murphy, CEO of NanoVibronix. “According to the Canadian Pain Task Force¹, nearly eight million, or one in four Canadians aged 15 or older live with chronic pain. Our pain management products are safe and effective alternative treatment to prescription opioids, which have been the root cause of a number of unintended consequences including overdose and death. Similarly, there are millions of urinary catheters used in hospitals every year, and our urology products can serve as protection against urinary tract infections and the pain associated with the catheters. We are eager to serve the Canadian market through Ideal Medical and look forward to capitalizing on this new opportunity to drive further growth.”

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 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) the geographic, social and economic impact of COVID-19 on the Company’s ability to conduct its business and raise capital in the future when needed, (ii) market acceptance of our existing and new products or lengthy product delays in key markets; (iii) negative or unreliable clinical trial results; (iv) inability to secure regulatory approvals for the sale of our products; (v) intense competition in the medical device industry from much larger, multinational companies; (vi) product liability claims; (vii) product malfunctions; (viii) our limited manufacturing capabilities and reliance on subcontractor assistance; (ix) insufficient or inadequate reimbursements by governmental and/or other third party payers for our products; (x) our ability to successfully obtain and maintain intellectual property protection covering our products; (xi) legislative or regulatory reform impacting the healthcare system in the U.S. or in foreign jurisdictions; (xii) our reliance on single suppliers for certain product components, (xiii) 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; (xiv) 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 (xv) 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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¹ Canadian Pain Task Force Report: October 2020

View source version on businesswire.com: https://www.businesswire.com/news/home/20220330005210/en/

Investor Contacts:

Brett Maas, Managing Principal, Hayden IR, LLC

brett@haydenir.com

(646) 536-7331

Source: NanoVibronix, Inc.

FAQ

What recent approval did NanoVibronix receive from Health Canada?

NanoVibronix received approval for its PainGuard and UroGuard products as licensed medical devices by Health Canada.

What is the significance of the partnership with Ideal Medical for NanoVibronix?

The partnership with Ideal Medical allows NanoVibronix to accelerate the distribution of its medical devices in Canada.

How does NanoVibronix's PainGuard address chronic pain in Canada?

PainGuard offers a safe and effective alternative to prescription opioids, targeting the needs of nearly eight million Canadians living with chronic pain.

What are the primary products of NanoVibronix?

NanoVibronix's primary products include PainShield and UroShield, which utilize low-intensity surface acoustic wave technology.