# A recombinant matrix to improve autologous tissue grafts

> **NIH NIH R44** · INSOMA BIO, INC. · 2022 · $936,817

## Abstract

Project Summary
The objective of this proposal is to further develop a new restorative tissue matrix which Phase I studies indicate
is capable of expanding the utility of autologous fat grafting in breast reconstructive surgery. This objective is
motivated by the need to improve the accessibility and safety of breast reconstruction for cancer patients. Breast
implants dominate the field as they are easy to place and provide a defined shape. However, growing concerns
over the long-term impact of implants with regards to capsular contracture, breast implant illness (BII) and breast
implant associated anaplastic large cell lymphoma (BIA-ALCL) are driving many patients to seek other options.
Tissue flap procedures effectively deliver large sections of fat to the defect; however, these procedures are
complex, expensive, and not widely available to all patients. The long-term outcomes of successful tissue flaps
are favorable but associated with significant investment in time, money, bodily scars, and effort. A third option
is autologous fat, which can also be transferred as a graft using only liposuction and small injection cannulas as
an outpatient procedure. Despite its potential, many surgeons feel limited in their capabilities when using fat
grafts as: (1) harvesting fat with liposuction destroys its structural matrix, resulting in a shapeless slurry, and (2)
many patients simply do not have enough fat to donate. To date, the technical and surgical barriers to using fat
grafting for definitive breast reconstruction have not been solved. While attempts have been made to improve
graft success rates by combining tissue with synthetic polymers or decellularized tissue, these attempts have
shown minimal success due to a lack of intrinsic bioactivity, high cost, or long processing times. Recombinant
protein polymers are an unexplored but promising alternative, whereby mimics of naturally occurring extracellular
matrix proteins can be synthesized at high yield with molecular level control of their properties. Motivated by this
clear clinical need, this proposal seeks to advance commercialization of a recently developed innovative
biomatrix —Fractomer. Fractomers are artificial proteins designed to mimic soft tissue that can be co-injected
with fat to expand volume, increase long-term stability, and improve fat shape by allowing tissue ingrowth and
blood vessel formation. The Phase I program focused on Fractomer’s interaction with lipoaspirate to determine
biomechanical and thermal response properties ideally suited to a tissue repair matrix. In vivo studies
demonstrated Fractomer’s ability to promote cellular infiltration and vascularization associated with repair and
remodeling, as opposed to scar formation and fibrosis. Finally, in a murine flank fat grafting model, Fractomer
enabled the retention of form, localization, and structure of fat grafts up to three months. During Phase II we will
continue commercial development of Fractomer by: 1) scaling man...

## Key facts

- **NIH application ID:** 10384086
- **Project number:** 2R44CA244110-02A1
- **Recipient organization:** INSOMA BIO, INC.
- **Principal Investigator:** Stefan Roberts
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $936,817
- **Award type:** 2
- **Project period:** 2019-09-11 → 2024-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10384086

## Citation

> US National Institutes of Health, RePORTER application 10384086, A recombinant matrix to improve autologous tissue grafts (2R44CA244110-02A1). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10384086. Licensed CC0.

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