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Strain-Programmed Bioadhesive Patch for Enhanced Diabetic Wound Healing

Award Number: R44DK137615
ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/07/2023
PERIOD OF PERFORMANCE END DATE: 08/31/2025

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Strain-Programmed Bioadhesive Patch for Enhanced Diabetic Wound Healing - 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.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $0 )
2026	2024	SANAHEAL INC	100 CHESTNUT ST STE 300	SOMERVILLE	MA	02143	MIDDLESEX	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	2	11/19/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $1,105,432 )
2024	2024	SANAHEAL INC	363 MARLBOROUGH ST	BOSTON	MA	02115	SUFFOLK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	2	8/7/2024	NON-COMPETING CONTINUATION	$1,105,432
2024	2023	SANAHEAL INC	363 MARLBOROUGH ST	BOSTON	MA	02115	SUFFOLK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	8/6/2024	NEW	$0
														Subtotal = $1,105,432

Issue Date FY: 2023 ( Subtotal = $1,105,432 )
2023	2023	SANAHEAL INC	363 MARLBOROUGH ST	BOSTON	MA	02115	SUFFOLK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	9/7/2023	NEW	$1,105,432
														Subtotal = $1,105,432

Grand Total All Awards = $2,210,864

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Strain-Programmed Bioadhesive Patch for Enhanced Diabetic Wound Healing

Award Number: R44DK137615

ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/07/2023

PERIOD OF PERFORMANCE END DATE: 08/31/2025

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