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NanoVibronix Announces Publication of Compelling Study Results for UroShield in The Journal of Medical & Surgical Urology

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NanoVibronix, Inc. (NASDAQ: NAOV) announced significant findings from a study published in The Journal of Medical & Surgical Urology, confirming the effectiveness of its UroShield device in real-world settings. The study showed that 100% of participants reported ease of use and significant health benefits, including a reduction in urinary tract infections and pain. Conducted with 23 patients over 12 weeks, researchers concluded that UroShield is an appropriate treatment for persistent UTIs. The study aims to support future NICE Guidance for the device.

Positive
  • 100% of study participants reported ease of use and continued using UroShield after the study.
  • Significant reduction in urinary tract infections and pain was observed among participants.
  • Independent research supports UroShield's efficacy, reinforcing its market potential.
  • Study conducted in diverse real-world settings, bolstering product applicability.
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  • None.

Real World Evidence Confirms Effectiveness and Ease of Use of UroShield

Elmsford, NY, July 22, 2021 (GLOBE NEWSWIRE) -- NanoVibronix, Inc., (NASDAQ: NAOV), a medical device company that produces the UroShield® and PainShield® Surface Acoustic Wave (“SAW”) Portable Ultrasonic Therapeutic Devices, today announced that The Journal of Medical & Surgical Urology is publishing an article with overwhelmingly positive findings from a study of patients that used its UroShield in real world settings.

“This independent study is further proof of the effectiveness and applicability of our UroShield device in reducing the incidence of urinary tract infections and the pain and discomfort caused by urinary catheters,” stated Brian Murphy, Chief Executive Officer of NanoVibronix, Inc. “As we would expect, the patient experiences in the study were statistically significant, with all responding patients reporting that our device was simple, easy to use and materially benefitted them. The patient experiences were so profoundly positive that 100% of the study’s participants are continuing to use the device following the conclusion of the study.”

Murphy added, “Importantly, the study was conducted in real world settings, including private residences and long-term care facilities. Study participants, who often relied on family members and other assistants, achieved positive outcomes without the benefit of trained clinicians and skilled care givers, reinforcing our assertion of the ease of use of the UroShield device.”

For the study, 23 patients with reoccurring UTIs were offered to use UroShield for a minimum period of 12 weeks. Objective and subjective measures of improvement were recorded every week, including the number of UTIs, antibiotic treatment, catheter blockage and changes, bladder washout, hospitalizations or nurse visits due to UTIs, level of pain, sleep and mobility. In the findings, patients reported a significant decrease in the number of UTIs and antibiotic treatment, had fewer catheter blockages and catheter changes and pain was reduced significantly by the end of the study.      

Researchers at Coventry University concluded that ‘UroShield reduced the number of UTIs, catheter blockages and changes, and consequently the need for antibiotics. Patients reported the device is easy to use, were related to little to no pain, and overall improved patients’ well-being and mobility.’ The researchers suggest that the device should be considered as an appropriate treatment in long-term persistent UTIs.

The peer reviewed publication  has been submitted to the National Institute for Clinical Excellence (NICE) as further clinical evidence towards UroShield achieving NICE Guidance.

A link to the complete article will be made available on the company’s website at: nanovibronix.com.

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, and include, among others, statements regarding the completion of the public offering, the satisfaction of customary closing conditions related to the public offering and the intended use of net proceeds from the public offering; 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, 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 (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.


FAQ

What did the recent study find about NanoVibronix's UroShield device?

The study found that UroShield significantly reduces the incidence of urinary tract infections and pain, with 100% of participants reporting ease of use.

How many patients participated in the UroShield study?

The study involved 23 patients with recurring urinary tract infections.

What is the significance of the UroShield study's publication?

The study's publication in a peer-reviewed journal supports UroShield's effectiveness and could influence NICE Guidance for its use.

How long did the UroShield study last?

The study lasted for a minimum period of 12 weeks.

What is the primary benefit reported by UroShield users?

Participants reported significant decreases in urinary tract infections and pain while using UroShield.

NanoVibronix, Inc.

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