SBIR Phase II: Sprayable Hydrogel Sealant for Gastrointestinal Wound Protection

Abstracts are a public record of active and expired awards and are an important source of information on NSF activities. The purpose of the Abstract is to describe the project and justify the expenditure of Federal funds. Abstracts must not contain inappropriate or confidential information, and because they are available to such a wide audience, high standards of quality must be maintained in preparing them. The NSF award abstract has two parts, which should appear in the following order: -Part 1: A nontechnical description of the project, which explains the project's significance and importance. This description also serves as a public justification for NSF funding by articulating how the project serves the national interest, as stated by NSF's mission: to promote the progress of science; to advance the national health, prosperity and welfare; or to secure the national defense. This part of the abstract should describe the fundamental issues the project seeks to address, as well as other potential benefits, such as how the project advances the field, supports education and diversity, or benefits society. This part should be understandable by a broad audience. -Part 2: A technical description of the project that states its goals and scope, the methods and approaches to be used, and its potential contribution. In many cases, the technical project description may be a modified version of the project summary that is submitted with the proposal. However, the technical description should reflect any changes in the project's goals made after the review process. -Part 3: The Statement of Merit Review, "This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria." This statement is non-editable and added to every proposal Abstract once it has been saved in eJacket. This statement is viewable after the Abstract has been saved, and is read-only. Upon award of a proposal, the Abstract is available in the Award Search application and via FastLane. The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project lies in addressing a critical unmet need in gastrointestinal (GI) bleeding management. This project aims to develop the first sprayable hemostatic hydrogel solution for managing GI lesions, with the potential to significantly improve outcomes for patients undergoing GI procedures and at risk of bleeding. By offering a minimally invasive, bio-adhesive hydrogel that provides sustained lesion protection and hemostasis, this innovation could reduce intraprocedural and post-procedural complications such as mucosal bleeding and perforation, lower healthcare costs, and improve access to advanced GI treatments. The technology’s ease of use also has the potential to bridge disparities in healthcare outcomes between high- and low-volume centers, fostering better access and trust in GI screening colonoscopies that have been critical in the reduction of colon cancer incidence. Beyond GI applications, the hydrogel’s unique properties could be adapted for use in other surgical procedures and fields, such as sustained drug delivery, providing innovative solutions to address additional unmet therapeutic needs. This Small Business Innovation Research (SBIR) Phase II project focuses on advancing the development of a novel hydrogel delivery system that seamlessly integrates with endoscopic procedures. The project tackles critical technical challenges, including optimizing catheter design for precise spray patterns, preventing clogging, and ensuring compatibility with commercial endoscopes. It also involves developing a hand-held device equipped with an embedded gas system to enable controlled and accurate hydrogel application under a variety of clinical conditions. The system will undergo comprehensive validation through in-vitro simulations, ex-vivo tissue testing, and in-vivo preclinical trials to ensure its safety, efficacy, and usability. These efforts aim to address the limitations of existing GI wound management technologies, positioning the system for FDA 510(k) regulatory submission and paving the way for commercialization and widespread clinical adoption. This project represents a transformative advancement in medical device innovation, delivering improved solutions for gastrointestinal lesion management. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.