Appealing to potential Regulatory agencies to increase use to reduce burden on the healthcare system
NanoVibronix to expand use of its UroShield. (Credit: Darko Stojanovic from Pixabay.)
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”.
Source: Company Press Release