SBIR-STTR Award

Enteral nutrition using feeding tubes provides a long-term means of improving the nutritional status for infants and children with neurological syndromes, cancer, gastrointestinal disease, cardiac disease, and metabolic disease by allowing administration of feeding formula directly to the stomach through the upper abdomen. More than 70,000 pediatric percutaneous gastrostomy (PG) tubes are placed in US hospitals annually. The majority of PG tube complications-resulting in 15% morbidity-include microbial contamination, tube clogging, dislodgement, and stomal complications. Prevention of PG tube complications requires implementation of innovative biomaterials that are safe for vulnerable infant and child populations. This directive is consistent with the NIH goals of improving human health, as well as the specific 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. In pursuit of those important goals, Sharklet Technologies Inc. proposes to incorporate a bio-inspired Sharklet micropattern on pediatric PG tubes to significantly reduce bacterial contamination, clogging, displacement, and stomal complications. The anticipated impact of this technology is to reduce PG device failure, thereby generally improving infant and child health for thousands and minimizing pediatric patient morbidity. The Sharklet micropattern achieves these effects without the use of chemical additives or toxic compounds, which is important for a pediatric population that is typically more sensitive to medical device surface chemicals. The power of Sharklet is that the novel micropattern can be produced in the same approved biomedical materials used currently. The improved PG device envisioned by the Sharklet R&D team is expected to 1) reduce bacterial contamination that causes infections, 2) improve feeding formula flow to reduce clogging, and 3) enhance stoma formation to limit dislodgement and painful stoma site cellulitis. The feasibility of attaining each of these improvements will be pursued by the expert Sharklet interdisciplinary team via two main Phase I SBIR Specific Aims {involving testing device prototypes with the Sharklet micropattern}. Aim 1 will focus on {implementing} the Sharklet micropattern to the PG tube lumen to reduce feeding formula accumulation by at least 50% (p<0.05) and microbial biofilm formation by >90% (p<0.05). Aim 2 will focus on {implementing} the Sharklet micropattern to the device exterior to promote at least 50% (p<0.05) faster in vitro epidermal keratinocyte migration and >25% (p<0.05) thicker stomal wall formation in vivo. Key preliminary work by Sharklet is a strong foundation for achieving these Aims. Once Phase I SBIR milestones are met, a follow-on Phase II SBIR project will be focused on completing development/commercialization of the Sharklet Micropatterned PG device. Sharklet Technologies has extensive experience in developing and commercializing medical devices: previous incorporation of the Sharklet micropattern for {alternative mechanisms of preventing device complications} have been accomplished on a Foley urinary catheter and an endotracheal tube.

Public Health Relevance Statement:


Public Health Relevance:
More than 70,000 pediatric feeding tubes are placed in the US annually, and they are associated with 15% morbidity due to infections, clogging, dislodgement, and stoma site cellulitis. Sharklet Technologies, Inc proposes to substantially reduce morbidity through incorporation of the Sharklet micro-texture produced in the same silicone plastics currently in use, which is especially important for pediatric populations where toxic chemicals and additives are not well tolerated. The micro-texture will reduce bacterial contamination that causes infections, improve feeding formula flow to reduce clogging, and enhance stoma formation to limit dislodgement and painful stoma site cellulitis.

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.

Public Health Relevance Statement:
Project Narrative Pediatric patients, whose conditions do not permit oral feeding, rely on percutaneous gastrostomy (PG) to deliver long-term nutrition. The pediatric enteral feeding world market is expected to grow to $108 million in 2020 from $73 million in 2013. PG tube placement however, often is associated with complications such as infection, tube clogging and poor stoma formation. Sharklet Technologies Inc., with outstanding preliminary results from Phase I SBIR efforts, proposes a continuing Phase II project to validate the efficacy and scale up development of the Sharklet pediatric PG device that will significantly reduce risks of PG-associated infection and tube clogging, as well as will improve stoma formation. The potential commercialization potential is high as this novel PG device prevents complications described above without any additional chemical, providing an efficacious while safe option for children.

Project Terms:
Abdomen; Address; Adherence; adult nutrition; Anti-Infective Agents; Area; Bacterial Attachment Site; base; Biocompatible Materials; Biomedical Engineering; Businesses; Caring; cell motility; Chemicals; Chemistry; Child; Childhood; Clinical Research; Clinical Trials; Collaborations; commercialization; cost; design; Development; Device Designs; Devices; Dimensions; disability; Disease; economic cost; Ensure; Enteral; Enteral Feeding; Enteral Nutrition; Epithelial Cells; Equipment Malfunction; expectation; experience; Extravasation; Family suidae; feeding; Funding; Gastrostomy; Generations; Goals; healing; high risk infant; Hospitals; Human; implantation; improved; In Vitro; in vitro testing; industry partner; Infection; innovation; instrument; interest; Investments; Lead; Legal patent; Letters; Liquid substance; lot production; Manufacturer Name; Medical; Medical Device; Methods; microbial; Microbial Biofilms; Mission; Modeling; Morbidity - disease rate; multidisciplinary; National Institute of Child Health and Human Development; Neonatal; novel; nutrition; Nutritional status; Oral; Pathway interactions; Patients; pediatric patients; Performance; performance tests; Phase; phase 1 study; Phase II Clinical Trials; Poisons; Population; post-market; pre-clinical; prevent; Prevention; Process; product development; Public Health; Regulation; Research; Research Methodology; response; Risk; Safety; safety testing; scale up; Shark; Silicones; skills; Skin; Small Business Innovation Research Grant; Stomach; Stomas; success; Surface; System; Technology; Testing; Thick; Trauma; Traumatic injury; Tube; Validation; verification and validation; Work; Wound Healing