BIOCREDE INC. — Department of Health and Human Services STTR Phase II: 300

Description

DESCRIPTION provided by applicant In Phase I Biocrede developed a completely new urinary tract silicone Foley catheter with a andgt month shelf life made from a proprietary polymeric formulation to effectively reduce catheter associated urinary tract infections CAUTI via nitric oxide NO release for andgt weeks Key features of the new technology include catheters continuously deliver NO at bactericidal rates for andgt d at C In vitro data demonstrate a fold reduction of live bacteria counts for key bacteria strains associated with CAUTI on catheter surfaces and ability to prevent biofilm formation at days ongoing study shows that shelf life can easily be extended beyond andgt andgt months after ETO sterilization ISO GLP leaching tests d and associated toxicity studies on cells d and in mice d received the safest scores possible and urologists praised the consistency elasticity and flexibility of the product compared to others The NO released from the surfaces of the catheter quickly diffuses out of the silicone walls into the urine collection lumen and from the catheterandapos s outer surface to prevent disrupt biofilm formation that will eliminate CAUTIs CAUTIs contribute to million nosocomial hospital infections annually with a cumulative incidence of per day of catheterization at days andgt at days long term leading to complications such as cystitis pyelonephritis gram negative bacteremia prostatitis epididymitis urosepsis septicemia etc in patients This technology will help reduce the costs associated with CAUTIs $ per infection and potentially prevent most of the deaths year due to CAUTIs in the US alone To continue research and development of this advanced product we propose to prove that NO releasing catheters can be stored for months or more after EtO sterilization develop assemble a controlled Allan Bradley automated system to allow repeatable SNAP S nitroso N acetyl penicillamine impregnation and lean operation efforts prove the safety CAUTI prevention efficacy and biocompatibility of our new NO releasing Foley catheter design via animal studies rabbits after d and d n each verify and design for lowest possible SNAP leaching perform all of the required GLP third party biocompatibility studies for future k application in and receive the FDA IDE approval by Achieving these goals will allow Biocrede to work with investors to fund a future clinical Phase I pilot study and clinical Phase II final study for our k De novo applications Fortune Medical an FDA approved and ISO certified company is Biocredeandapos s catheter OEM provider and Biocrede US owned Ann Arbor MI will add the proprietary components SNAP impregnation technology and perform quality control sterilization and packaging This proprietary technology is being licensed by Biocrede Inc through the Offices of Tech Transfer at the University of Michigan Ann Arbor MI PUBLIC HEALTH RELEVANCE Catheter associated urinary tract infections CAUTI contribute to million nosocomial hospital infections with a cumulative incidence of per day of catheterization at days andgt at days long term leading to complications and approximately ten thousand deaths annually Current CAUTI prevention techniques including use of routine irrigation of the bladder with antimicrobials and silver coate Foley catheters have andquot no significant preventative effectsandquot as stated by the Healthcare Infection Control Practices Advisory Committee We propose a novel and price competitive urinary tract silicone Foley catheter made from a proprietary polymeric formulation to effectively reduce CAUTIs by providing andgt days of tested bactericidal effectiveness via nitric oxide NO release and allowing dry storage for at least months ongoing study without significant loss of NO release capability