Sam Brusco, Associate Editor11.16.22
NanoVibronix, a company using proprietary and patented low-intensity surface acoustic wave (SAW) tech, released interim results of its UK clinical study of UroShield being conducted by The University of Southampton and the National Biofilms Innovation Centre.
Initial results suggested changes in the microbial population diversity after using UroShield, with possible beneficial effects on the urinary and catheter microbiome. Further, most patients using UroShield reported fewer catheter blockages and infections.
The study began in April 2021 to fill a gap in the firm’s clinical evidence and establish documentation needed by the FDA for a 510(k) clearance. As part of the preliminary clinical study, microbiological analyses of urine and catheter samples before and after UroShield use were made via a combination of culture, microscopy, and sequencing tech.
“We are encouraged by the interim results we received from the Southampton quantitative and qualitative study for UroShield,” NanoVibronix CEO Brian Murphy told the press. “The results are positive and are an important next step towards our expansion in the UK market and securing permanent clearance from the FDA and ramping up production for distribution in the U.S. We look forward to receiving additional information when the study is published in 2023.”
Initial results suggested changes in the microbial population diversity after using UroShield, with possible beneficial effects on the urinary and catheter microbiome. Further, most patients using UroShield reported fewer catheter blockages and infections.
The study began in April 2021 to fill a gap in the firm’s clinical evidence and establish documentation needed by the FDA for a 510(k) clearance. As part of the preliminary clinical study, microbiological analyses of urine and catheter samples before and after UroShield use were made via a combination of culture, microscopy, and sequencing tech.
“We are encouraged by the interim results we received from the Southampton quantitative and qualitative study for UroShield,” NanoVibronix CEO Brian Murphy told the press. “The results are positive and are an important next step towards our expansion in the UK market and securing permanent clearance from the FDA and ramping up production for distribution in the U.S. We look forward to receiving additional information when the study is published in 2023.”