# An off the shelf alternative to fat transfer for soft tissue repair

> **NIH NIH R43** · INSOMA BIO, INC. · 2024 · $293,983

## Abstract

Project Summary
The goal of this Phase I SBIR program is the development of an optimized, off-the-shelf alternative to autologous
fat grafting for soft tissue repair. Fat grafting is commonly used as a minimally invasive alternative to synthetic
implants or major reconstructive surgery (e.g., free flaps) for the repair of damaged, lost, or surgically resected
soft tissue, with particular focus on craniofacial, breast, and extremity reconstruction. It is one of the fastest
growing procedures in plastic surgery with an estimated 80% of reconstructive surgeons already incorporating
the procedure in their practice. However, fat grafting requires liposuction, an operation which liquifies the fat,
exposing it to shear forces which limit the capacity of fat to survive and retain shape once re-injected. A product
which can deliver the same results as an autologous graft in an office procedure without the need to process
and harvest tissue would be poised for rapid market adoption in this expanding field. To this end, this Phase I
grant will evaluate the collaborative combination of inSoma Bio’s tissue repair matrix – FractomerTM – with
Renuva®, an industry-leading adipose allograft material marketed through the Musculoskeletal Transplant
Foundation (MTF Biologics) as an off-the-shelf alternative to autologous fat transfer. Renuva is marketed to
restore volume in the face, hands, and body, and has shown significant clinical outcomes, restoring the adipocyte
population at the site of injection; however, cadaver-based products across the board are inherently limited by
scale and donor sourcing. As a result, access to markets for larger repairs such as facial reconstruction, surgical
sites such as lumpectomy defects, and regions of tissue wasting (e.g., lipodystrophy) are limited. Fractomer, on
the other hand, is a biosynthetic protein scaffold which can be produced at large scale using simple fermentation
and is designed to replicate the extracellular matrix. Fractomer has been shown to support long-term viability,
vascularization, and shape-retention when co-injected with human lipoaspirate. A product composed of both
Fractomer and Renuva has clear potential to supply both the scaffold and cellular cues needed without the need
to harvest tissue from the patient as well as significantly increase the maximum repair volume capacity, allowing
access to previously unreachable markets. Preliminary studies have already confirmed the capacity for these
two products to complement one another, and this SBIR will allow optimization of a commercially viable
formulation. Phase I studies will include testing mixtures of Fractomer and Renuva for injectability, thermally-
induced phase transition, shape retention, and support for cellular viability. In vivo studies will then be undertaken
to monitor cellular composition, adipogenesis, and signs of any adverse effect from inflammation or necrosis.
The resulting product would expand the range of surgical procedures suited t...

## Key facts

- **NIH application ID:** 10915818
- **Project number:** 1R43GM153037-01A1
- **Recipient organization:** INSOMA BIO, INC.
- **Principal Investigator:** Stefan Roberts
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $293,983
- **Award type:** 1
- **Project period:** 2024-09-01 → 2025-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10915818

## Citation

> US National Institutes of Health, RePORTER application 10915818, An off the shelf alternative to fat transfer for soft tissue repair (1R43GM153037-01A1). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10915818. Licensed CC0.

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