Benzinga | Dec 7, 2021 08:45AM EST

NanoVibronix Announces Interim Results In Real World Patient Study Of UroShield

NanoVibronix, Inc., (NASDAQ:NAOV), a healthcare device company that produces the UroShield(r) and PainShield(r) 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(tm) 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.