Full Press Release Details
Announces Agreement for Clinical Study of UroShield at the University of Michigan
Additional Clinical Evidence to Support Application to FDA for Permanent Clearance
N.Y., Nov. 28, 2023 (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 it has signed a Research Agreement with the Regents of the University of Michigan for a Randomized Control Trial
("RCT") study of UroShield.
Murphy, Chief Executive Officer of NanoVibronix, Inc., said, "We are partnering with a team of distinguished researchers at the
University of Michigan to further advance clinical evidence of the efficacy of UroShield. UroShield is cleared under the U.S. Food and
Drug Administration's ("FDA") Enforcement Discretion, and we hope positive outcomes from this independent study will
support an application to the FDA for permanent clearance. RCTs are considered the gold standard' in clinical research,
and we are pleased to be working with the team at the University of Michigan."
continued, "The research, which is being led by the Center for Research and Innovations in Special Populations (CRIISP), an experienced
and highly accomplished research team, will be conducted primarily with nursing home residents and is aimed at studying the impact UroShield
may have on reducing urinary tract infections, catheter blockages and pain and improving the quality of life of the patients studied.
The first phase of the study will include a validation pilot of 20 patients in advance of the full study. The full study is expected
to include more than 300 patients. We look forward to receiving the researchers' conclusions and hope for positive outcomes for
patients in the study. The study is expected to commence in the first half of 2024."
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 to 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.
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.
Maas, Managing Principal, Hayden IR, LLC