NanoVibronix Announces Encouraging Interim Results in Real World Patient Study of UroShield
Elmsford, NY, Dec. 07, 2021 (GLOBE NEWSWIRE) — NanoVibronix, Inc., (NASDAQ: NAOV), a healthcare device company that produces the UroShield® and PainShield® Surface Acoustic Wave (SAW) Portable Ultrasonic Therapeutic Devices, today announced positive interim results from an independent, real world patient study of its UroShield at Southampton University Health Sciences.
Brian Murphy, CEO of Nanovibronix, stated, “Interim results and observations from both the patient qualitative work and laboratory analysis are highly encouraging and represent another important step towards full commercialization of UroShield. Urine analysis is demonstrating an approximate 1 log reduction in bacterial numbers in most patients, a statistically significant outcome, indicating that UroShield is reducing the bacterial load responsible for colonizing a catheter which frequently leads to infection. Qualitatively, participants are citing positive outcomes and improved quality of life from using our UroShield device.”
The independent study, which was launched in the first half of 2021, 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. The study consists of both laboratory and patient studies and is nearing completion. 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. The research team has reported strong interest in the study from both the clinical teams and patients who live with long term catheters. Full results of the study are expected to be published in the second quarter of 2022.
According to Sandra Wilks, Director of Programmes Health (PGT) at University of Southampton, “The UroShield study which is both qualitative and quantitative, consisting of both laboratory and patient studies is nearing completion. The independent research team has experienced strong interest from the clinicians and patients who live with long term catheters with 12 participants already having consented to both the microbiology and device testing with the remainder identified and about to commence.
Additional patients are completing the qualitative part of the study which involves using the UroShield device for a minimum of 90 days with data collected every week. Analysis of Pathogenic Bacteria Culture in the urine to date is demonstrating an approximate 1 log reduction in bacterial numbers in most patients, indicating that UroShield is reducing the bacterial load that is responsible for colonising the catheter and causing infection. The interim results and observations from both the patient qualitative work and the laboratory analyses are very encouraging, with participants providing positive comments about the effects of the device and stating that it is improving their quality of life.”
UroShield™ is an ultrasound-based product that is designed to prevent bacterial colonization and biofilm in urinary catheters, increase antibiotic efficacy and decrease pain and discomfort associated with urinary catheter use.
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® 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; 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 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.
CONTACT: Brett Maas, Managing Principal Hayden IR, LLC 646-536-7331 brett@haydenir.com
