# Hemostatic Bioadhesive Paste for Coagulation-Independent Rapid Control of Bleeding

> **NIH NIH R44** · SANAHEAL, INC. · 2024 · $1,249,317

## Abstract

ABSTRACT
The objective of this proposal is to optimize and validate the hemostatic bioadhesive paste in compliance with
FDA regulatory guidance for the FDA IDE approval in advance of the future pivotal clinical trial and ultimate
regulatory clearance and commercialization. In light of the huge and rapidly growing clinical and economic costs
of major hemorrhagic events in cardiovascular and other surgeries, various hemostatic agents have been
developed and clinically tested. To date, however, there is no hemostatic solution that can achieve effective and
rapid hemostasis in frequent and high-risk bleeding of patients under anticoagulation or coagulopathic settings
due to the incompatibility of conventional coagulation-based hemostatic approaches. To address these
limitations of existing solutions, during the prior development (Phase I-equivalent), our collaborative team
developed a proof-of-concept prototype of a hemostatic bioadhesive paste for rapid (within 10 s) coagulation-
independent control of bleedings by uniquely utilizing the novel blood-resistant bioadhesive mechanism. The
preliminary pre-clinical validation and analysis based on in vivo rat and porcine models demonstrated the
promising hemostatic efficacy and underlying mechanism of the hemostatic bioadhesive paste for the
bioadhesion-based coagulation-independent rapid control of bleedings. Building upon the promising outcome of
the prior development, under the scope of this Direct-to-Phase II SBIR proposal, we will further optimize and
validate the hemostatic bioadhesive paste in compliance with relevant FDA regulatory guidance for the highly
effective and broadly affordable solution to treat high-risk bleeding in the anticoagulated or coagulopathic
patients. If successful, the proposed project will allow SanaHeal to prepare and submit the FDA IDE package in
advance to a pivotal clinical trial and ultimate commercialization with far-reaching benefits for patients and the
healthcare system.

## Key facts

- **NIH application ID:** 11007752
- **Project number:** 1R44HL176351-01
- **Recipient organization:** SANAHEAL, INC.
- **Principal Investigator:** Hyunwoo Yuk
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $1,249,317
- **Award type:** 1
- **Project period:** 2024-09-25 → 2026-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11007752

## Citation

> US National Institutes of Health, RePORTER application 11007752, Hemostatic Bioadhesive Paste for Coagulation-Independent Rapid Control of Bleeding (1R44HL176351-01). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/11007752. Licensed CC0.

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