NanoVibronix Announces First Shipments of new UroShield™ Devices
NanoVibronix, Inc. (NASDAQ: NAOV) has commenced shipments of its new UroShield® device to the UK. The company is collaborating with the National Institute of Clinical Evidence (NICE) to prepare for submission for official guidance, aiming to enhance access for NHS patients at risk of catheter-associated urinary tract infections (CAUTI). UroShield® is designed to prevent bacterial colonization in urinary catheters, thus reducing CAUTI rates and associated hospital stays. The company is also pursuing regulatory approvals in Australia and other markets.
- Shipments of UroShield® to the UK initiated, potentially increasing market reach.
- Collaboration with NICE to facilitate market access for NHS patients.
- UroShield® has shown effectiveness in reducing CAUTI through clinical trials.
- Dependence on regulatory approvals in additional markets could delay expansion.
- Risks related to competition in the medical device industry from larger firms.
- Possible impact of COVID-19 on business operations and capital raising.
ELMSFORD, N.Y., Aug. 13, 2020 /PRNewswire/ -- NanoVibronix, Inc., (NASDAQ: NAOV), a medical device company that produces the UroShield®, PainShield® and WoundShield®, and WoundShield® Surface Acoustic Wave (SAW) Portable Ultrasonic Therapeutic Devices, today announced that it has shipped its first orders of the new UroShield® device to the United Kingdom.
Contemporaneous with the fulfilment of new orders, the Company has been engaged with the National Institute of Clinical Evidence (NICE) on readying the new version of UroShield® for submission for NICE Official Guidance. This important step is intended to help accelerate market access to all NHS patients at risk of catheter associated urinary tract infections (CAUTI). The Company is also pursuing a similar registration process in Australia via the Therapeutic Goods Administration (TGA), as well as other regulatory agencies.
"The global Covid-19 pandemic has reinforced the widely known importance of preventing co-morbidity, which we believe may complicate and compromise patients stricken with the Covid-19 virus," said Brian Murphy, CEO of NanoVibronix. "UroShield has proven its effectiveness through several randomized controlled trials to significantly reduce Catheter Associated Urinary Tract Infection (CAUTI), one of the leading factors associated with Hospital Acquired Infection and increased hospital stays. We remain very excited about the potential for this product to improve the lives of patients."
UroShield® is an ultrasound-based product that is designed to prevent bacterial colonization and biofilm on indwelling urinary catheters and increase antibiotic efficacy, ultimately reducing the incidence of catheter-associated urinary tract infections (CAUTI). UroShield® is also intended to decrease pain and discomfort associated with urinary catheter 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) 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; and (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. 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.
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SOURCE NanoVibronix, Inc.
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