# DermiSphere: An Advanced Dermal Regeneration Scaffold for Reconstructive Surgery, PHASE II

> **NIH NIH R44** · FESARIUSTHERAPEUTICS, INC. · 2021 · $914,554

## Abstract

ABSTRACT
On its own, the human body is incapable of dermis regeneration. If not properly treated, large full-thickness
skin wounds (loss of epidermis and dermis) heal through contraction of surrounding skin and scar formation,
which may ultimately lead to chronic wounds, permanent damage, disfigurement and patient suffering. For
years, the gold-standard treatment has been autologous tissue transfer (a patient serving as their own donor),
but insufficient donor site availability, secondary contracture of split thickness skin grafts and major donor-site
morbidity leaves surgeons wanting alternatives. In the early 2000's, engineered treatments emerged, which
now have annual sales from $500MM to $1BN, growing 8-12% annually. The market leader, Integra™, has
several shortcomings in both the rate and degree of healing as well as decreased effectiveness in challenging
wounds. DermiSphere™, the proposed product of this application is an implantable dermal regenerative
scaffold that addresses these concerns. DermiSphere's (DS) patented 3D patterned microarchitecture guides
rapid cell penetration from the wound bed into the scaffold, leading to swift vascularization and neo-dermis
formation. Our previous studies treated clinically-relevant rodent and pig wounds with a DS prototype, and
demonstrated improved performance as compared to Integra (>75% graft take vs. ~50% respectively),
decreased hemorrhage, enhanced graft vitality and a 40% increase in dermal thickness. These all indicate
better clinical outcomes. Completion of this Phase II proposal will result in a frozen DS design that will then be
used in biocompatibility and validation testing as required for FDA 510(k) clearance. Furthermore, this frozen
design will be validated for superior performance versus Integra in a clinically relevant pig full-thickness wound
model. Specifically, the study will evaluate the value proposition determined during the NIH iCorps program
of ≥20% improvement in graft “take” time/incidence and wound contracture vs. Integra. In Phase II, we will
complete two Specific Aims 1: Design Freeze for the optimized DS. DS is two layers: a polysiloxane (silicone)
layer and a type I collagen scaffold (comprised of bulk collagen and embedded collagen microspheres). This
aim contains four tasks to develop the “final” version of the device meant for commercial use: (1) & (2)
Optimize microsphere size and crosslinking and bulk collagen using cGMP compliant collagen sources and
equipment; (3) Optimize the occlusive layer for clinical use; (4) Develop terminal sterilization parameters
without adversely affecting DS. The resulting prototypes will be screened for efficacy using a rat full-thickness
wound model. 2: Demonstrate superiority to the market leader and meet/exceed our performance value
proposition in the clinically-relevant, full-thickness excisional model in swine. An optimized DS with a frozen
design that has superior efficacy over Integra in a full-scale (porcine) wound model i...

## Key facts

- **NIH application ID:** 10260600
- **Project number:** 5R44AR076301-03
- **Recipient organization:** FESARIUSTHERAPEUTICS, INC.
- **Principal Investigator:** Yulia Sapir Lekhovitser
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $914,554
- **Award type:** 5
- **Project period:** 2020-01-01 → 2022-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10260600

## Citation

> US National Institutes of Health, RePORTER application 10260600, DermiSphere: An Advanced Dermal Regeneration Scaffold for Reconstructive Surgery, PHASE II (5R44AR076301-03). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10260600. Licensed CC0.

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