SBIR Phase I: Hemostatic Tough Adhesive Hydrogels for Advanced Biosurgery

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is to address longstanding unmet needs in bleeding control. Uncontrolled bleeding is a major intraoperative issue and postoperative complication with high economic impacts, increasing procedural costs up to $30,000. Of 1.6 million surgical procedures in the US, 15% or 240,000 patients underwent re-operation due to lack of hemostasis. Post-operative bleeding results in 2-3 times longer hospital stay (15 vs 6 days), 6 times longer ICU stay (6 vs 1 days) and increased costs of 3-4 times ($40k vs $14k). HemoMax has the potential to save 70,000 lives per year in the US and reduce the suffering and recovery time of many more patients worldwide. This project supports job creation by employing researchers, engineers, and technicians while fostering workforce development through specialized training in biomaterials, medical device manufacturing, and regulatory science. It contributes to industry competitiveness by developing highly skilled professionals who drive innovation in biomedical engineering and surgical hemostasis. Additionally, this work may result in patent filings and peer-reviewed publications, protecting intellectual property while disseminating cutting-edge research on biomaterial-based wound management to the scientific and clinical communities.

This Small Business Innovation Research (SBIR) Phase I project will translate a new hemostatic hydrogel for advanced bleeding. Limax’s bioinspired hydrogel design achieves adhesion energies 100 to 1,000 times greater than those of existing commercial adhesives on wet tissue surfaces. Adhesion occurs within minutes, is independent of blood exposure, and forms a robust seal compatible with dynamic in vivo environments. The proposed project will proceed in three phases: (1) Phase I will focus on optimizing HemoMax for the rapid and effective sealing of bleeding solid organs; (2) Phase II will evaluate the material’s performance after terminal sterilization, assessing retention of adhesive and mechanical properties under clinically relevant conditions; (3) Phase III will assess acute and chronic performance in a large animal model of partial nephrectomy, providing critical insights into in vivo efficacy and biocompatibility. Together, these studies will provide a comprehensive preclinical foundation to support the translation of HemoMax toward GLP-enabling studies, positioning the technology for future regulatory and clinical advancement.

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.

Award Number: 2528115
Principal Investigator: Phoebe Kwon
Funds Obligated: $305,000
State: MA