# An advanced dermal regeneration scaffold for skin loss due to burn wounds

> **NIH NIH R43** · FESARIUSTHERAPEUTICS, INC. · 2024 · $349,345

## Abstract

ABSTRACT
The gold standard treatment for large full thickness skin loss (FTSL) due to burns involves autologous tissue
transfer in which the patient serves as their own donor. However, such treatment may be challenging due to
limited availability of full thickness skin donor sites; thus most of these wounds are closed using split thickness
skin grafts (STSG), which contain only a fraction of the native dermal thickness, leading to suboptimal functional
outcomes. Dermal Replacement Scaffolds (DRS) aim to recreate dermis, thereby restoring normal skin anatomy.
These cell-free products serve as a scaffold for the infiltration of cells from the wound bed that organize to a
functional, vascularized neodermis tissue, able to support a STSG. The critical barrier to progress in this field is
to create a scaffold that 1) promotes rapid cellular infiltration and angiogenesis required for neodermis formation
in full thickness wounds, and 2) increases the efficiency and quality of healing in acute large burns.
To address this significant clinical gap, Fesarius Therapeutics, Inc. has developed DermiSphere™, an innovative
DRS product that will regenerate dermis in full thickness skin loss wounds significantly and meaningfully
faster (≤7 days) than the regeneration achieved using the market-leading DRS product, Integra® (14-28 days).
Our customer interview process has revealed additional requirements from a DRS that are currently
unmet/partially met: (1) ability to close the wound in a single procedure (2) ability to temporize the wound, (3)
ability to close difficult to heal wounds. Our preliminary data have demonstrated in a swine model of FTSL that
DermiSphere, unlike any other commercially available DRS, successfully supports complete STSG take
when the two components are applied simultaneously. In addition, a small animal model of FTSL 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. A remaining challenge in acute burn
wounds, unlike other causes of FTSL, is that simultaneous grafting is often not feasible. Adding a protective layer
that can be removed when it is clinically feasible to perform the graft, days to weeks later, will significantly improve
the clinical utility of DermiSphere and improve wound healing. Once dermis has regenerated it can be covered
with a thin skin autograft, yielding skin that is more flexible, functional, resilient and aesthetically superior than
wounds healed with Integra or STSG alone. Given the successful completion of these preliminary studies,
DermiSphere is now primed to expand its indication into challenging full thickness wounds such as burns to
expand the scope of product use. The overall goal of this SBIR Phase I proposal is to demonstrate
feasibility of DermiSphere as a device for the management of acute major burn wounds. The data
generated in these studies will directly inf...

## Key facts

- **NIH application ID:** 11005669
- **Project number:** 1R43GM156172-01
- **Recipient organization:** FESARIUSTHERAPEUTICS, INC.
- **Principal Investigator:** Yulia Sapir Lekhovitser
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $349,345
- **Award type:** 1
- **Project period:** 2024-09-01 → 2025-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11005669

## Citation

> US National Institutes of Health, RePORTER application 11005669, An advanced dermal regeneration scaffold for skin loss due to burn wounds (1R43GM156172-01). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/11005669. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*