# DermiSphere™: An Advanced Dermal Regeneration Scaffold for Reconstructive Surgery, CRP

> **NIH NIH SB1** · FESARIUSTHERAPEUTICS, INC. · 2024 · $396,663

## 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. Being cell-free products, these 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 skin graft which is implanted as a
second step procedure, resulting in a healed wound with normal skin dermal/epidermal architecture. However,
because currently available DRS lack unique cues to guide such 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.
The objective of this Commercial Readiness Pilot (CRP) is to complete late-stage development and enable
Fesarius to achieve 510(k) clearance. Development of scaled manufacturing capabilities of the DermiSphereTM
product represents one of the most important obstacles that must be surmounted in order to achieve broad-scale
clinical impact of this promising technology. The Specific Aims for this proposed project are to (1) Establish and
validate a cGMP-compatible manufacturing process which will prepare the DermiSphereTM product for
commercial release (2) Design and validate packaging and validate sterilization of the DermiSphereTM product;
(3) Complete real-time and accelerated stability validation for DermiSphereTM and its barrier packaging; and (4)
Submit...

## Key facts

- **NIH application ID:** 10907617
- **Project number:** 5SB1AR076301-05
- **Recipient organization:** FESARIUSTHERAPEUTICS, INC.
- **Principal Investigator:** Yulia Sapir Lekhovitser
- **Activity code:** SB1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $396,663
- **Award type:** 5
- **Project period:** 2019-09-01 → 2025-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10907617

## Citation

> US National Institutes of Health, RePORTER application 10907617, DermiSphere™: An Advanced Dermal Regeneration Scaffold for Reconstructive Surgery, CRP (5SB1AR076301-05). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10907617. Licensed CC0.

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