NOVASTERILIS, INC. — Department of Health and Human Services SBIR Phase I: NIAID

Description

DESCRIPTION provided by applicant It is critical to sterilize biomedical devices xenograft and allograft materials due to the rapid rise of antibiotic resistance in hospital acquired infections HAI For one major HAI pathogen Clostridium difficile the use of antibiotics promotes greater infection rates and worse outcome as the native intestinal flora is eliminated by the strong antibiotics used Songer and Anderson C difficile Staphylococcus aureus and Pseudomonas aeruginosa are responsible for many of the estimated million nosocomial infections resulting in over deaths in and with the estimate that one in twenty hospital patients will acquire an HAI www cdc gov HAI burden html www cdc gov HAI pdfs hai infections deaths pdf The estimated costs of HAI are well over $ billion with prevention costs estimated at below $ billion www cdc gov HAI pdfs hai Scott CostPaper pdf With the use of any sterilization system or antibiotic there is a need to identify the mechanism of microbicidal action of the molecule or factor involved Lessons learned from antibiotic resistance antibiotic promotion of C difficile infection and biocide resistance drive the requirement for characterizing new and long used biocideandapos s mechanisms of kill Understanding the critical cellular targets for biocides enables the development of innovative safe methods to control or eliminate the incidence of HAI For a novel sterilization method to be accepted for medical devices for internal and external use and for pharmaceuticals the U S Food and Drug Administration FDA now require identification of the mechanism of biocide action NovaSterilis Inc has completed two NIH Phase II grants resulting in a validated supercritical Carbon dioxide peracetic acid scCO PAA sterilization system on the market for soft and hard tissue and is developing sterilization of absorbable sutures This proposal addresses the FDA requirement for characterization of the mechanism of microbial kill by PAA in scCO NovaSterilisandapos commercial Nova system monitors the conditions required for formation and maintenance of supercritical CO but does not currently monitor concentrations of peracetic acid and stabilizer hydrogen peroxide solubilized in scCO The goals of the NovaSterilis Phase I program are to identify the mechanism of biocidal action of PAA and hydrogen in scCO on spores of the bacterium Bacillus subtilis one of the most resistant forms of life and to develop and test an inline meter to monitor microbicidal levels of PAA in the system This work will significantly advance FDA regulatory acceptance of scCO sterilization with PAA and hydrogen peroxide as co sterilants for medical devices and biologicals as well as for food and environmental systems utilizing PAA as a sterilant or co sterilant PUBLIC HEALTH RELEVANCE There is a clear need for a gentle nontoxic and biodegradable sterilization method for delicate medical devices and biomaterials Supercritical carbon dioxide scCO with peracetic acid PAA co sterilant has the potential to significantly improve the healthcare industryandapos s ability to meet the growing need for gentle and biocompatible sterilization methods for implantation of novel medical devices and allograft biomaterials