# An Advanced Dermal Regeneration Scaffold for Reconstructive Surgery

> **NIH NIH R44** · FESARIUSTHERAPEUTICS, INC. · 2024 · $50,000

## Abstract

PROJECT SUMMARY/ABSTRACT
Due to the inability of the dermis to regenerate on its own, large full thickness skin loss cannot be restored
naturally. The current gold standard treatment involves autologous tissue transfer in which the patient serves as
their own donor, which may be challenging due to limited availability of full thickness skin donor sites and donor-
site morbidity. Dermal Replacement Scaffolds (DRS) aim to recreate dermis, thereby preventing wound
contraction. However, because currently available DRS lack unique cues to guide cell infiltration, they may fail
to vascularize sufficiently. The critical barrier to progress in this field is to create a scaffold that 1) promotes rapid
cellular infiltration and angiogenesis as required for neodermal formation in full thickness wounds, and 2)
increases the incidence and quality of healing in both typical/healthy wounds and difficult to heal sites.
To address this significant clinical gap, Fesarius Therapeutics, Inc. is developing DermiSphere™, an innovative
DRS product that will regenerate dermis in full thickness skin loss wounds much faster (≤7 days, i.e. >75% faster)
than the regeneration achieved using the market-leading DRS product, Integra®. Once dermis has regenerated
it can be covered with a thin epidermal skin autograft, yielding skin that is more flexible, functional, and resilient
than wounds healed with split thickness skin grafts alone. The commercialization of DermiSphereTM is expected
to improve clinical practice in the surgical fields where full thickness skin loss is common including, but not limited
to, trauma, burns, infection and post oncologic reconstructive surgery, by significantly decreasing the time
required to achieve a healed wound in a scenario of large full thickness skin loss, which will directly result in
decreased patient suffering as well as lower expenditure of valuable health care resources.
Our preliminary data suggests that the current DermiSphere™ formulation will support all these unmet clinical
scenarios. We have demonstrated in a swine model of full thickness skin loss that DermiSphere™ successfully
supports complete split thickness skin graft (STSG) take when the two components are applied simultaneously.
In addition, a small animal model of full thickness skin loss showed that DermiSphere™ supported rapid and
sustained lateral as well as vertical cell invasion, resulting in successful STSG “take” in challenging cases of
wound beds with avascular portions and was able to revascularize templates up to 3mm thick. We have recently
brought the DermiSphere™ dermal regenerative template formulation to design freeze using a cGMP-material
based formulation that is terminally sterilized and are fast progressing in our technology transfer to a contract
manufacturing organization. The overall objective of this Direct to Phase II SBIR is to complete a powered,
clinically relevant large animal study (Aim 1), screen the DermiSphere™ product in challenging wounds ...

## Key facts

- **NIH application ID:** 11123713
- **Project number:** 3R44AR082787-01A1S1
- **Recipient organization:** FESARIUSTHERAPEUTICS, INC.
- **Principal Investigator:** Yulia Sapir Lekhovitser
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $50,000
- **Award type:** 3
- **Project period:** 2023-08-15 → 2025-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11123713

## Citation

> US National Institutes of Health, RePORTER application 11123713, An Advanced Dermal Regeneration Scaffold for Reconstructive Surgery (3R44AR082787-01A1S1). Retrieved via AI Analytics 2026-05-21 from https://api.ai-analytics.org/grant/nih/11123713. Licensed CC0.

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