NanoVibronix Announces Completion of Pilot Phase of Clinical Study of UroShield® at the University of Michigan

Rhea-AI Summary

NanoVibronix (NASDAQ: NAOV) has successfully completed the pilot phase of a Randomized Control Trial study for UroShield® at the University of Michigan. The study, primarily conducted with nursing home residents, focused on evaluating UroShield's impact on reducing urinary tract infections, catheter blockages, and pain associated with long-term urinary catheter use.

The completed pilot phase served as a validation step before advancing to the full study, which is expected to commence in 2025. The research team has achieved their initial goals, including refining recruitment strategies and developing data collection tools. This research complements previous studies and product launches in the UK, Australia, and New Zealand, as well as the recent introduction to the European market. The company is simultaneously preparing for a U.S. launch, pending FDA 510K clearance.

Positive

• Successful completion of UroShield® pilot study at University of Michigan
• Expansion of market presence with recent European market entry
• Established presence in UK, Australia, and New Zealand markets
• Progress toward potential US market entry pending FDA 510K clearance

Negative

• Full study not commencing until 2025
• Still awaiting FDA 510K clearance for US market entry

Insights

Medical Research Analyst

The completion of UroShield's pilot phase at the University of Michigan represents a preliminary step toward clinical validation, but lacks substantial data or outcomes to significantly impact investor decisions. While the study focuses on important clinical aspects like UTI reduction and catheter complications, the announcement merely confirms procedural progress rather than presenting actionable results. The advancement to a full Randomized Control Trial in 2025 indicates a lengthy timeline before potential FDA clearance and market entry. For a micro-cap company with a $2.3M market capitalization, the path to commercialization remains challenging and capital-intensive. The concurrent European market entry provides some diversification, but without concrete clinical data or revenue projections, this news primarily serves as a developmental milestone rather than a material catalyst. The pilot's completion mainly demonstrates operational execution in study design and recruitment rather than therapeutic efficacy.

Research expected to advance to ‘Full Study’ phase in 2025

ELMSFORD, N.Y.--(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 the successful completion of the first phase of a Randomized Control Trial study of UroShield® by researchers at the University of Michigan (“UM”).

This first phase of the trial is a precursor to the full study by researchers at UM. It was conducted primarily with nursing home residents and was aimed at studying the impact of UroShield® on improving patient’s quality of life by its potential to reduce urinary tract infections, catheter blockages and pain caused by the long-term use of urinary catheters.

Brian Murphy, Chief Executive Officer of the Company, commented, “The first phase of the study served as a validation pilot in advance of a full study. With this phase now complete, researchers at UM can advance to the next phase, a full Randomized Control Trial of additional patients. We expect the full trial to commence in 2025.”

Mr. Murphy continued, “The validation our products continue to receive from independent research and the progress we are making towards further commercializing UroShield is highly encouraging. This research builds on previously concluded studies and product launches in the U.K., Australia and New Zealand and our recent introduction of UroShield to the European market. The next phase of the UM study is expected to be conducted concurrently with our preparations for the launch of UroShield in the U.S., subject to 510K clearance with the U.S. Food and Drug Administration.”

Dr. Lona Mody, Professor of Internal Medicine at the University of Michigan, commented, “Our team has achieved the goals of this pilot phase, including refining our recruitment and retention strategies, delivering the intervention and developing data collection tools. We look forward to the next phase.”

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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250106356255/en/

Investor Contact:

Brett Maas, Managing Principal, Hayden IR, LLC

brett@haydenir.com

(646) 536-7331

Source: NanoVibronix, Inc.

FAQ

When will the full UroShield® clinical trial begin at University of Michigan for NAOV?

The full Randomized Control Trial is expected to commence in 2025.

What markets is NanoVibronix's UroShield® currently available in?

UroShield® is currently available in the UK, Australia, New Zealand, and has recently been introduced to the European market.

What was the primary focus of NAOV's UroShield® pilot study?

The pilot study focused on evaluating UroShield's impact on reducing urinary tract infections, catheter blockages, and pain in nursing home residents using long-term urinary catheters.

What regulatory approval does NAOV need for UroShield® US market entry?

NanoVibronix needs to obtain 510K clearance from the U.S. Food and Drug Administration (FDA) before launching UroShield® in the US market.