NanoVibronix Receives Positive Final Results of Independent Lifecycle Testing of PainShield Prompted by Centers for Medicare and Medicaid Services (CMS)

Rhea-AI Summary

NanoVibronix, Inc. (NASDAQ: NAOV) announced successful independent life expectancy testing for its PainShield device, affirming that it met all functionalities required. The testing, conducted by Carmel Labs in Israel, confirms the device’s reliability. CEO Brian Murphy indicated that the results will support their pending application for Medicare coverage, following a prior denial in September 2022 due to insufficient data. This advancement is expected to enhance the product's market availability and potential reimbursement opportunities.

Positive

• Completion of independent life expectancy testing for PainShield, confirming it met all functionalities.
• Testing results will support the application for Medicare coverage, potentially increasing market access.

Negative

• Previous denial of Medicare coverage due to lack of sufficient life expectancy testing data.
• Market acceptance remains uncertain until Medicare approval is obtained.

All functionalities proven to be within testing performance criteria

ELMSFORD, N.Y.--(BUSINESS WIRE)-- NanoVibronix, Inc., (NASDAQ: NAOV) (the “Company”), a medical device company utilizing the Company's proprietary and patented low intensity surface acoustic wave (“SAW”) technology, today announced that independent life expectancy testing performed by Carmel Labs in Israel confirm that its PainShield met all tested functionalities.

Brian Murphy, Chief Executive Officer of NanoVibronix, “Independent third-party testing results confirm that PainShield, our non-opioid, ultrasound therapy device for pain, met the defined testing parameters for lifecycle expectancy. We plan to submit the results of the testing to the Centers for Medicare and Medicaid Services (CMS) to backfill our pending application for Medicare coverage.”

Murphy continued, “As you may recall, we were notified in September of 2022 by CMS that PainShield lacked sufficient life expectancy testing data, and therefore denied Medicare coverage. We subsequently commissioned the testing services of an independent, third party and received positive interim test results in January of this year. Today, we are confirming the testing is complete and the results were overwhelmingly positive. We believe these results clear the way for us to move forward with securing approval from CMS and ultimately making our device more widely available to those who could benefit from its use.”

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®, UroShield® and WoundShield®, all of 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, e.g., 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/20230328005305/en/

Investor Contacts:

Brett Maas, Managing Principal, Hayden IR, LLC

brett@haydenir.com

(646) 536-7331

Source: NanoVibronix, Inc.

FAQ

What did NanoVibronix announce about PainShield on March 28, 2023?

NanoVibronix announced that independent testing confirmed PainShield met all functionalities required for life expectancy.

How will the testing results for PainShield affect its Medicare application?

The positive testing results will be submitted to Medicare to support their pending application for coverage.

What was the reason for the previous denial of Medicare coverage for PainShield?

Medicare previously denied coverage due to insufficient life expectancy testing data.

What is the significance of the independent testing conducted by Carmel Labs?

The independent testing validates the reliability of PainShield, which is crucial for obtaining Medicare coverage.

What is the stock symbol for NanoVibronix?

The stock symbol for NanoVibronix is NAOV.