NanoVibronix Announces Commencement of UroShield Clinical Study at the University of Michigan

Rhea-AI Summary

NanoVibronix (Nasdaq: NAOV) announced the start of the pilot phase for the UroShield clinical trial at the University of Michigan. This phase is the initial part of a broader study, following a Research Agreement signed on November 28, 2023. The trial aims to evaluate UroShield's efficacy in reducing urinary tract infections, catheter blockage, and pain, thereby enhancing patient quality of life. The pilot phase involves up to 30 patients, while the full study will involve approximately 300 patients, primarily from nursing homes. The goal is to gather data that will support an application for permanent FDA clearance or approval.

Positive

• Initiation of pilot phase for UroShield study at the University of Michigan.
• Potential improvement in patient quality of life by reducing urinary tract infections, catheter blockage, and pain.
• Collaboration with the experienced research team at the University of Michigan.
• Future plans for a full study involving approximately 300 patients.

Negative

• The trial is still in the pilot phase, with final results pending.
• initial participant number (up to 30) may not provide comprehensive data.
• Dependence on successful trial results for FDA clearance or approval.

ELMSFORD, N.Y.--(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 the University of Michigan will begin the pilot phase of its clinical trial of UroShield this week. The “pilot” phase of the study is the first component of the broader study.

As previously announced on November 28, 2023, the company signed a Research Agreement with the Regents of the University of Michigan for a Randomized Control Trial (“RCT”) study of UroShield to further advance clinical evidence of the efficacy of UroShield. This link will take you to the company’s previous press release.

Brian Murphy, Chief Executive Officer of NanoVibronix, Inc., said, “Entering into the pilot phase of the UroShield study at the University of Michigan is an important step towards our goal of applying for permanent FDA clearance or approval for the UroShield product. The experienced and highly accomplished team of researchers at Michigan is studying the impact UroShield may have on reducing urinary tract infections, catheter blockage pain and improving the quality of life of the patients studied. The pilot portion of the study will include up to 30 patients, while the full study is expected to encompass an estimated 300 patients, primarily nursing home residents.”

About NanoVibronix

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 PainShield® product is a portable device 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/20240522503771/en/

Investor Contact:

Brett Maas, Managing Principal, Hayden IR, LLC

brett@haydenir.com

(646) 536-7331

Source: NanoVibronix, Inc.

FAQ

What is the UroShield clinical trial?

The UroShield clinical trial is a study to evaluate the efficacy of NanoVibronix's UroShield device in reducing urinary tract infections, catheter blockage, and pain.

Where is the UroShield clinical trial being conducted?

The trial is being conducted at the University of Michigan.

When did the UroShield clinical trial begin?

The pilot phase of the trial began the week of November 28, 2023.

How many participants are in the UroShield pilot study?

The pilot phase will include up to 30 participants.

What is the goal of the UroShield study?

The goal is to gather clinical evidence to support an application for permanent FDA clearance or approval of the UroShield device.

Who will be the primary participants in the UroShield full study?

The full study will primarily involve nursing home residents, with approximately 300 participants.

What potential benefits does the UroShield device offer?

UroShield aims to reduce urinary tract infections, catheter blockage, pain, and improve the quality of life for patients.

What is NanoVibronix's stock symbol?

The stock symbol for NanoVibronix is NAOV.