Research Project
9348125
Summary In a variety of diseases and conditions when oral feeding is impossible, enteral feeding through percutaneous gastrostomy (PG) is necessary to provide long-term nutrition for adult and pediatric patients. It is estimated that over 70 thousand feeding tubes are placed in pediatric patients in the US annually. However, these patients frequently experience complications associated with PG tube placement. Late-onset complications (at least 6 days after PG insertion) were estimated to be 44% in pediatric patients. Common complications include infections, tube clogging, tube dislodgement and poor stoma formation. Poor stoma formation, in particular, leads to a variety of problems such as peristomal infection and gastric content leakage. PG-associated complications often require hospital revisions, resulting in higher economic cost as well as increased patient morbidity and discomfort. Revisions are estimated to cost over $1 million annually in pediatric PG patients in the US alone. Therefore, effective strategies are required to prevent these complications, without introducing more issues, in children whose nutrition is dependent on PG feeding. Here, Sharklet Technologies, Inc. proposes to develop a novel Sharklet-micropatterned pediatric PG device that is anti- infective, anti-clogging and improves stoma formation in children who receive enteral feeding. The power of the Sharklet technology is that the novel micropattern can be produced in the same approved biomedical materials used currently, without the addition of any potentially toxic chemical. It therefore offers a safe solution for vulnerable infant and child populations, consistent with NICHD goals of ensuring that all children have the chance to achieve their full potential for healthy and productive lives, free from disease and disability. Sharklet Technologies, Inc. (STI) applies proprietary micrometer-scale topography onto a variety of medical and consumer devices in order to control bioadhesion. Design of the Sharklet micropattern is inspired by the microtopography on shark skin that has a natural anti-fouling activity. STI has received Phase I SBIR funding to test the feasibility of Sharklet pediatric PG tubes and majority of milestones have been achieved. Sharklet surfaces have been shown to reduce at least 50% feeding formula accumulation and prevent microbial biofilms by 89%. In addition, Sharklet micropattern promotes human epithelial cell migration towards wounded areas by 167%. Building on these successes, in this Phase II project, STI proposes to verify the efficacy of Sharklet PG devices in reducing complications, and to manufacture and commercialize this novel device for pediatric patients. Phase II Aims are proposed to scale up Sharklet PG development: Aim 1 ?Develop manufacturing for a silicone PG tube using design controls and product development to produce a first-generation product; Aim 2 ?Examine first- generation PG tubes for performance against in vitro tests of anti-clogging, bacterial contamination prevention, and cell migration improvement; Aim 3 ?Test 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 trauma; Aim 4 ? Manufacture a final production lot of PG tubes for validation and verification testing such that requirements are met for 510k submission with the claim equivalence compared to a predicate device. Phase II results will lead to the submission of a 510(k) regulatory package for a device-level claim. The strong Phase I success and the broad-based technical, business and regulatory skills of STI?s expert, multi- disciplinary 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 partner. In all, the 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.
