NanoVibronix touts lowered UTIs in interim UroShield study results

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NanoVibronix

NanoVibronix (NSDQ:NAOV) today released interim results from a trial of its UroShield ultrasound device designed to prevent bacteria and biofilms from forming on urinary catheters, touting a low rate of catheter-acquired urinary tract infections.

The Uroshield device from the Elmsford, N.Y.-based company is designed to decrease pain and discomfort associated with urinary catheter use while also preventing bacterial colonization and biofilm on indwelling catheters to reduce UTIs.

The 51-patient trial examined patients at 5 nursing facilities, with 26 patients being treated with the UroShield and 25 in a control group receiving the standard of care. All patients in the trial had been treated for at least 1 incident of CAUTIs requiring antibiotics 6-months prior to the trial, the company said.

At 90-days, 52% of the control group individuals had developed a CAUTI which required antibiotic intervention, while only 4% of the UroShield patients acquired one.

All subjects were initially recorded with a colony count of greater 100,000 CFU cultured from their urinary tract, NanoVibronix said. UroShield patients showed reductions in this count, however, with 15 patients having counts reduced to 10,000 CFU at 90 days and 10 patients reduced to 1,000 CFU.

“We are pleased to report the interim results of this latest study, demonstrating a material reduction in the rate of CAUTI. These successful results reinforce our earlier data demonstrating a significant reduction in infection rates and bacterial colonization on catheter devices when using UroShield. We believe that the fact that UroShield already has European and Canadian marketing clearance, a strong safety profile including our predicate devices, as well as strong data from this and other ongoing studies, should help to accelerate 510(k) marketing clearance with the United States Food and Drug Administration. We also plan to use this evidence to bolster our European and Canadian marketing efforts while working through the FDA application, and plan to start developing a distribution network in the U.S. in advance of marketing clearance. The reduction in the rate of CAUTI further illustrates the potential to reduce healthcare costs, improve outcomes, and enhance quality of life for patients. We are very encouraged by the outlook for this product, as we are not aware of any other local device that has demonstrated this type of short-term and long-term prevention of CAUTI in the catheterized patient population,” CEO Brian Murphy said in a press release.

Yesterday, NanoVibronix said it pulled down more than $5 million from a public stock offering for its Surface Acoustic Wave antimicrobial platform.

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