NanoVibronix Reports Schedule Published by NICE for Review of UroShield® Device
Provides Milestones for Attaining NICE Guidance, Including Addition of UroShield to the NHS Supply Chain; Process Completion and Recommendation Expected in Q1 2022
ELMSFORD, N.Y.--(BUSINESS WIRE)--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 it has received documentation from the National Institute for Health and Care Excellence (NICE) that outlines the timeline for NICE’s review and recommendation of the company’s UroShield device.
Publication of the approval schedule and timeline more clearly codifies the process that the company believes will ultimately lead to a positive recommendation of the device by NICE adoption by the National Health Service (NHS) as a clinically effective and cost saving medical device and addition of the device to the NHS Supply Chain Catalogue. As an important element of this approval, funding may also be provided by the NHS through the Medtech Funding Mandate, demonstrating the NHS commitment to accelerate the uptake of NICE-approved, cost-saving medical devices throughout the health system, meaning patients will get access to these technologies faster.
“Publication by NICE of its schedule for the review of the independent study and its recommendation for UroShield is an important step towards attaining ‘official guidance’ and ultimately achieving adoption by NHS for use by all of its patients at risk of catheter associated urinary tract infections,” stated Brian Murphy, CEO of NanoVibronix. “Findings from the recent independent study demonstrate statistically significant benefits and positive outcomes from patients that use the medical device. We remain committed to full commercialization of UroShield and are encouraged by NICE’s addition of the study to its evidence-based medicine documentation.”
The date for publication for rollout to the NHS is March, 2022, coinciding with the NHS financial year, which begins on April 1st and details of the UroShield review process are made available online by NICE at https://www.nice.org.uk/guidance/indevelopment/gid-mt560.
“NICE has achieved wide international impact, leading the way for more evidence-based value assessment of medicines and medical devices,” continued Murphy. “The NICE process for review, recommendation and approval has helped global health systems and clinicians to focus the practice of medicine where it matters most from both a quality of patient care and cost effectiveness perspective.”
As previously announced, the company submitted to NICE for review, the findings from an independent evaluation of its UroShield® device on patients who had used the device for up to two years.. Clinical data from the study, conducted by Coventry University’s Assistant Professor, Ksenija Maravic da Silva, reported statistically significant outcomes for the device including a reduced number of urinary tract infections (UTIs), reduced instances of prescribed antibiotics, reduced catheter blockages, reduced the need for unplanned catheter changes and reduced pain reported as a result of catheter associated complications. The study also provided important insights into the lives of those using the device including improvement of overall well-being, relating specifically to decreased levels of worry and increased ability to socialize. In addition, patient feedback on product improvements were addressed and have been incorporated in the present commercially available device.
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.
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