Sbir phase II: sprayable hydrogel sealant for gastrointestinal wound protection

This Cooperative Agreement award from the National Science Foundation (NSF) under the Technology, Innovation, and Partnerships (CFDA 47.084) program provides $1,250,000 in funding to Biodevek Inc., a Boston-based small business, to advance the development of a novel hydrogel delivery system for managing gastrointestinal (GI) lesions and bleeding. The project aims to create the first sprayable hemostatic hydrogel solution for endoscopic procedures, with the potential to improve outcomes, reduce complications, and increase access to critical GI treatments. Key technical objectives include optimizing the hydrogel's catheter delivery system, preventing clogging, and ensuring compatibility with commercial endoscopes. The project will involve comprehensive validation through in-vitro, ex-vivo, and in-vivo preclinical testing to support the hydrogel's eventual regulatory approval and commercialization as a minimally invasive, bio-adhesive solution for GI wound protection and hemostasis.

Abstract

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.- subawards are not planned for this award.