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Novel peptide-impregnated hydrogel as a wound healing device

Award Number: R44DE026080
ORGANIZATION: NATIONAL INSTITUTE OF DENTAL AND CRANIOFACIAL RESEARCH
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 04/01/2016
PERIOD OF PERFORMANCE END DATE: 08/31/2025

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Novel peptide-impregnated hydrogel as a wound healing device - PROJECT SUMMARY / ABSTRACT Wounds healing with exuberant fibrotic scarring or wounds that fail to heal represent two opposing ends of the wound repair spectrum. Fibrotic scarring in highly visible areas after craniofacial reconstruction can result in severe functional and cosmetic disability. Similarly, wound dehiscence—wound tissue separation due to a failure to heal with adequate tensile strength—can be life-threatening if it exposes vital structures such as viscera, brain, or blood vessels. Even if non-life-threatening, dehiscence can disrupt critical repairs such as in tendons, hernias, cleft lips and palates (one of the most prevalent congenital craniofacial conditions with post-repair dehiscence rates up to 22.76%). Additionally, ~43% of abdominal incisional hernia cases are secondary to wound dehiscence. More importantly, wound dehiscence mortality rates can be as high as 14%-50%. Unfortunately, all available tissue approximation devices (e.g., sutures, staples, adhesives) only bring tissues together in a purely mechanical fashion. There are no devices to actively promote fibroblast migration and myofibroblast contraction to increase wound tensile strength. To address current device limitations, we developed an SLI-F06 peptide-containing hyaluronic acid (HA) hydrogel (HA-SLI-F06). SLI-F06 promotes fibroblast migration, contraction, and collagen cross-linking to accelerate wound tensile strength reestablishment while HA provides a “bridge” to facilitate cellular migration. An injectable SLI-F06 first-in-class drug is currently in a Phase 1/2a clinical trial to minimize dermal scar formation. However, injecting the liquid SLI-F06 is time- consuming for larger wounds and impractical for thin tissues such as fascia. This PAR-19-333 Commercialization Readiness Pilot (CRP) Program directly continues the Direct-to-Phase II SBIR award R44DE026080, and is designed to accelerate the Clinical Trial Application for the novel bioactive HA-SLI-F06 hydrogel. HA-SLI-F06 can be applied contemporaneously with most any tissue approximation devices during surgery to enhance wound healing. Pig efficacy data showed a significant wound tensile strength increase in wounds treated with HA-SLI-F06 compared to controls. To expedite and derisk technical, regulatory/clinical, and business milestone activities that could impact or delay HA-SLI-F06 commercialization, we propose: AIM 1 to develop the Chemistry, Manufacturing, and Controls (CMC) to minimize technical HA-SLI-F06 production risks; AIM 2 to conduct essential safety studies to support HA-SLI-F06 application in a broad range of soft tissues; AIM 3 to expedite clinical development and minimize regulatory risks by incorporating quantifiable tools to ensure optimal clinical study design and efficient clinical methods to assess safety and efficacy to meet the FDA requirements; and AIM 4 to fully integrate our intellectual property, market focus, and business strategies to maximize valuation. If successful, this product will represent a new paradigm enabling surgeons to easily convert most any mechanical tissue approximation device (e.g., sutures, staples, mesh, adhesives) into a bioactive tissue approximation device to accelerate tensile reestablishment and reduce wound dehiscence, while also decreasing scarring.


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	2023	SCARLESS LABORATORIES, INC.	1124 W CARSON ST BLDG MRL FL 3	TORRANCE	CA	90502	LOS ANGELES	USA	Oral Diseases and Disorders Research	000	5	2/5/2026	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $1,077,096 )
2023	2023	SCARLESS LABORATORIES INC	570 WESTWOOD PLAZA CNSI BUILDING	LOS ANGELES	CA	90095	LOS ANGELES	USA	Oral Diseases and Disorders Research	001	5	7/31/2023	NON-COMPETING CONTINUATION	$1,077,096
2023	2022	SCARLESS LABORATORIES INC	570 WESTWOOD PLAZA, CNSI BUILDING-SUITE 6350	LOS ANGELES	CA	90095	LOS ANGELES	USA	Oral Diseases and Disorders Research	000	4	10/26/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $1,077,096

Issue Date FY: 2022 ( Subtotal = $1,338,339 )
2022	2022	SCARLESS LABORATORIES INC	570 WESTWOOD PLAZA, CNSI BUILDING-SUITE 6350	LOS ANGELES	CA	90095	LOS ANGELES	USA	Oral Diseases and Disorders Research	001	4	8/23/2022	NON-COMPETING CONTINUATION	$1,338,339
2022	2021	SCARLESS LABORATORIES INC	570 WESTWOOD PLAZA, CNSI BUILDING-SUITE 6350	LOS ANGELES	CA	90095	LOS ANGELES	USA	Oral Diseases and Disorders Research	000	3	5/16/2022	COMPETING CONTINUATION	$0
														Subtotal = $1,338,339

Issue Date FY: 2021 ( Subtotal = $902,470 )
2021	2021	SCARLESS LABORATORIES INC	570 WESTWOOD PLAZA, CNSI BUILDING-SUITE 6350	LOS ANGELES	CA	90095	LOS ANGELES	USA	Oral Diseases and Disorders Research	000	3	8/24/2021	COMPETING CONTINUATION	$902,470
														Subtotal = $902,470

Issue Date FY: 2019 ( Subtotal = $0 )
2019	2017	SCARLESS LABORATORIES INC	570 WESTWOOD PLAZA, CNSI BUILDING-SUITE 6350	LOS ANGELES	CA	90095	LOS ANGELES	USA	Oral Diseases and Disorders Research	000	2	7/15/2019	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2017 ( Subtotal = $544,364 )
2017	2017	SCARLESS LABORATORIES INC	115 N. DOHENY DR.	BEVERLY HILLS	CA	90211	LOS ANGELES	USA	Oral Diseases and Disorders Research	000	2	2/24/2017	NON-COMPETING CONTINUATION	$544,364
														Subtotal = $544,364

Issue Date FY: 2016 ( Subtotal = $860,274 )
2016	2016	SCARLESS LABORATORIES INC	115 NORTH DOHENY DRIVE	BEVERLY HILLS	CA	90211	LOS ANGELES	USA	Oral Diseases and Disorders Research	000	1	3/16/2016	NEW	$860,274
														Subtotal = $860,274

Grand Total All Awards = $4,722,543

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Novel peptide-impregnated hydrogel as a wound healing device

Award Number: R44DE026080

ORGANIZATION: NATIONAL INSTITUTE OF DENTAL AND CRANIOFACIAL RESEARCH

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 04/01/2016

PERIOD OF PERFORMANCE END DATE: 08/31/2025

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