Out-licensing

NovaBay has developed a catheter irrigation solution containing NVC-422, a non-antibiotic, broad spectrum anti-microbial agent with activity on viruses, gram + and - bacteria and fungi .

Catheter-associated urinary tract infection (CAUTI) is the most common nosocomial infection in hospitals and nursing homes. It has been associated with increased morbidity, mortality, increased length of stay in hospitals and increased costs. Although CAUTI can occur in patients with short to medium term catheters (less than 30 days), it is a major issue in patients with long term urinary catheters due to blockage of urinary catheters. Some patients are more prone to blockage than others and can block their catheter several times a year. These "frequent blockers" represent between 15% and 20% of the overall population of long term catheterized patients.

There is no proven effective prevention technique for both CAUTI and catheter blockage other than using sterile techniques when inserting and taking care of the catheter and frequent replacement of blocked catheters. Some silver coated or antiseptic impregnated catheters may delay the onset of blockage with some patients but sooner or later the catheters will get blocked.

NovaBay has developed a catheter irrigation solution containing NVC-422, a non-antibiotic, broad spectrum anti-microbial agent with activity on viruses, gram + and - bacteria and fungi with the potential to reduce the buildup of urologic pathogens in the bladder and the lumen of catheters. In addition, NVC-422 catheter irrigation solution has been shown to prevent the formation of biofilms, thereby potentially reducing the incidence of blockage as well as limiting the colonization of those biofilms by pathogens.

NVC-422 catheter irrigation solution was shown to be safe at concentrations up to 0.1% in a human phase 1 study. In vitro studies have shown no development of resistance. One dose three times a week, flushed through the catheter into the bladder and left for 15 minutes before being drained, NVC-422 has the potential for being a simple, effective alternative for reducing the incidence of UTI and blockage in patients with long term indwelling Foley catheters.

Patients that would benefit most from an effective prevention method for CAUTI and catheter blockage include stroke, ALS, Alzheimer, spinal cord injury, multiple sclerosis and Parkinson's patients, comprising most of the long term urinary catheter population.

While there is no effective prevention method, saline and renacidin are sometimes used for prevention of blockage despite any clinical evidence of efficacy. Renacidin irrigation solution needs to be administered two to three times every day to be effective. There is also no drug that we are aware of that is in development for this indication.

Phase II

The composition of matter patent for NVC-422 has issued in the US and pending in other countries. Additional utility and formulation patent applications have been filed in multiple countries.

Phase 2b study results expected in Q2 2012

NovaBay is planning to commercialize this product in the US. We are seeking a collaboration partner to participate in the phase 3 program and to commercialize this product in the rest of the world.

US Patent No 7,462,361 - US Patent No 7,893,109