Sharklet Technologies Inc. — Department of Health and Human Services SBIR Phase II: NICHD

Description

Summary In a variety of diseases and conditions when oral feeding is impossibleenteral feeding through percutaneous gastrostomyPGis necessary to provide long term nutrition for adult and pediatric patientsIt is estimated that overthousand feeding tubes are placed in pediatric patients in the US annuallyHoweverthese patients frequently experience complications associated with PG tube placementLate onset complicationsat leastdays after PG insertionwere estimated to bein pediatric patientsCommon complications include infectionstube cloggingtube dislodgement and poor stoma formationPoor stoma formationin particularleads to a variety of problems such as peristomal infection and gastric content leakagePG associated complications often require hospital revisionsresulting in higher economic cost as well as increased patient morbidity and discomfortRevisions are estimated to cost over $million annually in pediatric PG patients in the US aloneThereforeeffective strategies are required to prevent these complicationswithout introducing more issuesin children whose nutrition is dependent on PG feedingHereSharklet TechnologiesIncproposes to develop a novel Sharklet micropatterned pediatric PG device that is antiinfectiveanti clogging and improves stoma formation in children who receive enteral feedingThe power of the Sharklet technology is that the novel micropattern can be produced in the same approved biomedical materials used currentlywithout the addition of any potentially toxic chemicalIt therefore offers a safe solution for vulnerable infant and child populationsconsistent with NICHD goals of ensuring that all children have the chance to achieve their full potential for healthy and productive livesfree from disease and disabilitySharklet TechnologiesIncSTIapplies proprietary micrometer scale topography onto a variety of medical and consumer devices in order to control bioadhesionDesign of the Sharklet micropattern is inspired by the microtopography on shark skin that has a natural anti fouling activitySTI has received Phase I SBIR funding to test the feasibility of Sharklet pediatric PG tubes and majority of milestones have been achievedSharklet surfaces have been shown to reduce at leastfeeding formula accumulation and prevent microbial biofilms byIn additionSharklet micropattern promotes human epithelial cell migration towards wounded areas byBuilding on these successesin this Phase II projectSTI proposes to verify the efficacy of Sharklet PG devices in reducing complicationsand to manufacture and commercialize this novel device for pediatric patientsPhase II Aims are proposed to scale up Sharklet PG developmentAimDevelop manufacturing for a silicone PG tube using design controls and product development to produce a first generation productAimExamine firstgeneration PG tubes for performance against in vitro tests of anti cloggingbacterial contamination preventionand cell migration improvementAimTest the PG tube for use in a preclinical porcine model of feeding tube implantation to demonstrate improved stoma formation in the presence of bacterial contamination or traumaAimManufacture a final production lot of PG tubes for validation and verification testing such that requirements are met fork submission with the claim equivalence compared to a predicate devicePhase II results will lead to the submission of akregulatory package for a device level claimThe strong Phase I success and the broad based technicalbusiness and regulatory skills of STI s expertmultidisciplinary team sets the stage for a successful Phase II manufacturing and validation project designed to lead to post Phase II clinical trials in collaboration with a third party investor or industry partnerIn allthe proposed Phase II project will validate the efficacy of this innovative PG product that harbors multiple patented Sharklet micropatterns to minimize PG associated complications in pediatric populations