Independent Study Being Led by Southampton University Health Sciences
Patient Recruitment Underway; Interim Results Expected in October 2021
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 an independent, real world patient study of its UroShield has commenced at Southampton University Health Sciences in partnership with Southern Health NHS Foundation Trust, an NHS health service provider of community services in the United Kingdom.
“This is another step forward in our efforts towards NHS fully adopting UroShield as a unique preventative device,” stated Brian Murphy, CEO of NanoVibronix. “We are eager to receive the results of this independent study as there are an estimated 100,000 patients living in community settings in the U.K. who are reliant on indwelling catheters and at risk of developing a catheter-associated urinary tract infection (CAUTI). There are also an additional 154,000 patients hospitalized annually who are catheterized for more than 48 hours and are also at risk for infection. These populations represent a sizeable opportunity to both improve the health of a large number of patients and significantly accelerate the full commercialization of our device.”
The 16-week independent study was devised to evaluate how UroShield helps to reduce infection by preventing bacteria colonisation and the buildup of biofilms on long-term indwelling urinary catheters in real world patients and to better understand the patient benefits and experiences of using UroShield. Patient recruitment has started and is expected to include up to 30 total real-world patients who have a history of catheter infections, blockages and pain and have not previously used the UroShield device. The study’s participants are living in their own homes with long-term indwelling catheters and are under the care of Southern Health NHS Foundation Trust.
Interim results of the study are expected to be available in October 2021 with full results published early in 2022. At the conclusion of the study, Southern Health will be able to purchase the UroShield devices for all patients that want to continue using the device and for additional patients in their care who have indwelling catheters.
About Southern Health NHS Foundation Trust
Southern Health NHS Foundation Trust is one of the largest providers of community health, specialist mental health and learning disability services for people across the south of England. They provide these services to 1.8 million people with a skilled workforce of approximately 6,000 people operating from more than 200 sites including community hospitals, health centres, inpatient units and social care services.
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.
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; (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.
Brett Maas, Managing Principal, Hayden IR, LLC