# Strain-Programmed Bioadhesive Patch for Enhanced Diabetic Wound Healing

> **NIH NIH R44** · SANAHEAL, INC. · 2024 · $1,105,432

## Abstract

ABSTRACT
The objective of this proposal is to optimize and validate the strain-programmed bioadhesive patch 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 chronic diabetic wounds and associated complications, various treatments including skin scaffolds and growth-
factor-based drugs have been proposed and clinically tested. To date, however, the existing approaches still
face several limitations for diabetic wound healing including limited therapeutic efficacy and/or high cost of
product/treatment. 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 strain-programmed bioadhesive
patch for enhanced diabetic wound healing by uniquely utilizing pro-regenerative mechanical modulation. The
preliminary pre-clinical validation and analysis based on in vivo db/db mice, diabetic porcine, and diabetic
humanized mice models revealed the promising therapeutic potential and underlying mechanisms of the strain-
programmed bioadhesive patch for the accelerated healing of diabetic cutaneous wounds. Building upon the
promising outcome of the prior development, under the scope of this Direct Phase II SBIR proposal, we will
further optimize and validate the strain-programmed bioadhesive patch in compliance with relevant FDA
regulatory guidance for the effective and broadly affordable treatment of chronic diabetic wounds such as DFU.
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:** 10924020
- **Project number:** 5R44DK137615-02
- **Recipient organization:** SANAHEAL, INC.
- **Principal Investigator:** Hyunwoo Yuk
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $1,105,432
- **Award type:** 5
- **Project period:** 2023-09-07 → 2025-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10924020

## Citation

> US National Institutes of Health, RePORTER application 10924020, Strain-Programmed Bioadhesive Patch for Enhanced Diabetic Wound Healing (5R44DK137615-02). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10924020. Licensed CC0.

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