# First and Only Soft Tissue Support Device to Improve Patient Experience and System Cost in Breast Reconstruction

> **NIH NIH R44** · SURGICAL INNOVATION ASSOCIATES, INC. · 2020 · $1,517,631

## Abstract

NOTE: These pages contain proprietary/privileged information. SIA requests that they not be released to persons
 outside the Government, except for purposes of review and evaluation.
Project Summary/Abstract
DuraSorb™ is poised to significantly improve the lives of the over 100,000 US women undergoing post-
mastectomy breast reconstruction every year.
The current standard of care in implant-based breast reconstruction (IBBR) is the use of cadaveric acellular
dermal matrix (ADM) as a sling for the implant, rather than placing the implant fully under the pectoralis
muscle. ADM was introduced 10+ years ago to provide technical benefits of decreased pain, fewer return visits
between reconstructive stages, better cosmetic results, and decreased rates of capsular contracture around
the implant. However, it has been associated with a 10% increase in risk of surgical site complications
including seroma, infection, and flap necrosis. Furthermore, it has an unsustainable cost of $3,500-$4,850 per
breast. Alternative synthetic meshes have been being investigated as early as 2007. However, to date, studies
are limited to small case series with short follow-up and utilize meshes that may be tolerated in a hernia repair,
but present clinical problems in the setting of a mastectomy skin flap with tenuous vascularity.
DuraSorb™ is made of polydioxanone, a well-known polymer that is among the least inflammatory used in
implantable devices. The minimal inflammatory response to the material and its full-degradation over 6-9
months prevent chronic inflammation and give DuraSorb™ the characteristics of a biologic mesh. Additionally,
its open-knit, macroporous design allows for tissue integration. Further, it is produced with monofilament fibers,
which are less prone to biofilm formation than ADM. The unique properties of synthetic DuraSorb™ could
deliver the technical benefits of ADM without the increased complications, and at a fifth of the cost.
In this Direct to Phase II SBIR proposal, SIA will acquire the clinical data required to achieve the first and only
FDA clearance for prosthetic breast reconstruction in the US, above and beyond the clinical data collected for
510(k) clearance (August 2018, K181094). A 100 patient multi-center single arm trial will be conducted with a
retrospective, propensity-matched control to demonstrate performance and safety of DuraSorb™ and to
evaluate patient reported outcomes in a clinical trial.
NOTE: These pages contain proprietary/privileged information. SIA requests that they not be released to persons
 outside the Government, except for purposes of review and evaluation.

## Key facts

- **NIH application ID:** 10021634
- **Project number:** 5R44CA247273-02
- **Recipient organization:** SURGICAL INNOVATION ASSOCIATES, INC.
- **Principal Investigator:** John Y Kim
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $1,517,631
- **Award type:** 5
- **Project period:** 2019-09-20 → 2021-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10021634

## Citation

> US National Institutes of Health, RePORTER application 10021634, First and Only Soft Tissue Support Device to Improve Patient Experience and System Cost in Breast Reconstruction (5R44CA247273-02). Retrieved via AI Analytics 2026-06-23 from https://api.ai-analytics.org/grant/nih/10021634. Licensed CC0.

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