ELMSFORD, N.Y., March 27, 2020 (GLOBE NEWSWIRE) — NanoVibronix, Inc., (NASDAQ: NAOV), a medical device company that produces the UroShield® Surface Acoustic Wave (SAW) Portable Ultra Sonic therapeutic device which attaches to an indwelling catheter and has been clinically proven to mitigate Catheter Associated Urinary Tract Infection (CAUTI), as well as reducing pain and blockages, today announced that it has reached out to regulatory agencies around the world to inform them of the potential benefits for greater use of the product on compromised patients. As a result of the COVID-19 crisis, critically ill patients are at the greatest risk, especially when compromised by comorbidities, such as CAUTI. Additionally, with the existing and potential burden this crisis has on the worldwide healthcare system, critical patients may be displaced to lower acuity care settings. UroShield has been proven to reduce the incidence of CAUTI and as a result, has the potential to reduce readmissions into acute care facilities.
According to the CDC, each year, 15-25% of hospitalized patients and 5-10% (75,000-150,000) of nursing home residents will receive a urinary catheter. Statistics show that 75% of hospital patients and 50% of nursing home patients will develop a catheter-associated urinary tract infection (CAUTI). In fact, Urinary Tract Infections (UTI) account for more than 40% of the Hospital Acquired Infections (HAI). In addition, catheter acquired (symptomatic) UTIs are the source for 20% of Healthcare Acquired Bacteremia in acute care and 50% in long term care facilities.
This has resulted in an increased morbidity (i.e., leading cause of secondary blood stream infection with approx. 10% mortality) and an estimated 13,000 attributable deaths annually. In addition to the loss of life, these infections cost $400 to $500 million annually for treatment. With the COVID-19 crisis, mortality is much more likely when there are one or more comorbidities.
“Currently, we are aware of no other commercially available urinary catheters or accessories that assist in prevention or reduction of incidence of symptomatic UTI,” said Brian Murphy, CEO of NanoVibronix. “The COVID-19 crisis has demonstrated the importance of in-home and nursing home care for high-acuity patients in an attempt to reduce inpatient care. We are also sensitive to the needs of our hospitals to minimize the burden placed on our healthcare system so severely taxed by this crisis. We believe that our UroShield is a powerful tool for hospitals and physicians to mitigate these costly and dangerous problems. Our UroShield has been proven to be safe and effective and has regulatory approvals outside the USA.”
The UroShield device is CE Marked and is currently marketed outside USA (Europe and some Asian countries). In multiple randomized clinical studies, UroShield has proven to minimize the incidence of CAUTI and to alleviate the discomfort (such as discomfort during insertion and removal of catheter, pain, soreness, burning, itching and bladder spasms) associated with a urinary catheter. We strongly believe that a device that can effectively prevent “a serious disease or condition” far outweighs the value of a device intended to “treat or diagnose” the same “serious disease or condition”.
There is no assurance of broader adoption by regulators, but the benefits certainly outweigh the risks.
NanoVibronix Inc. (NASDAQ: NAOV) is a medical device company headquartered in Elmsford, New York, with research and development in Nesher, Israel, which is focused on developing medical devices utilizing its proprietary and patented low intensity surface acoustic wave (SAW) technology. This technology allows for the creation of low-frequency ultrasound waves that can be utilized for a variety of medical applications, including the disruption of biofilms and bacteria colonization, as well as providing 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™. Additional information about the Company 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 and 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) an 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 subcontractors for assistance, (viii) insufficient or inadequate reimbursement by governmental and other third party payers for our products, (ix) our efforts to successfully obtain and maintain intellectual property protection covering our products, which may not be successful, (x) legislative or regulatory reform of the healthcare system in both the U.S. and foreign jurisdictions, (xi) our reliance on single suppliers for certain product components, (xii) the fact that we will need to raise additional capital to meet our business requirements in the future and that such capital may not be available, or may be costly, dilutive or difficult to obtain and (xiii) the fact that we conduct business in multiple foreign jurisdictions, exposing us to foreign currency exchange rate fluctuations, logistical and communications challenges, burdens and costs of compliance with foreign laws and political and economic instability in each jurisdiction. 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.
Brett Maas, Managing Principal, Hayden IR, LLC