# Prospective evaluation of a surgical solution for breast cancer-associated lymphedema

> **NIH NIH R44** · FIBRALIGN CORPORATION · 2020 · $32,935

## Abstract

Project Summary/Abstract
Prospective evaluation of a surgical solution for breast cancer-associated lymphedema
The proposed project will complete remaining key research and technology requirements that are
needed to commercialize a ground-breaking interventional device for treating secondary lymphedema
-- a chronic and debilitating disease that currently has no cure and impacts an estimated 15-30% of
breast cancer survivors.
Breast cancer staging and cure typically necessitates surgery, with or without adjunctive radiation
therapy. These interventions, while life-saving, sometimes destroy enough lymphatic function that the
breast cancer survivor is left with a condition in the arm that can include painful swelling, frequent
infections that can be life-threatening and, ultimately, irreversible structural changes in the tissues that
result in severe deformity, and serious reduction in function and quality-of-life.
BioBridge is a novel, thread-like collagen scaffold designed to support the regeneration of new healthy
lymphatic vessels that will repair diseased tissue in patients that are suffering from breast cancer related
lymphedema. Based on results from an earlier, successful large animal study, it is hypothesize that this
novel device will provide the first ever treatment to measurably restore lymphatic function, reduce
swelling, and improve the patient’s quality of life.
A primary goal of this project is evaluate BioBridge efficacy in human subjects. A defined protocol has
been developed that will be used to test 120 subjects that have Stage I or Stage II breast cancer-related
lymphedema in a multi-site clinical study and led by Stanford University. When successfully completed,
the study will have generated critical quantitative data that will confirm the ability of the BioBridge to
reverse disease and compare its efficacy to the existing treatment strategies for lymphedema.
Another goal is to scale up the fabrication technology to support commercial production of BioBridge
devices. A proprietary manufacturing process has already been successfully developed and deployed
for lower volume production. This project will now focus on developing and scaling the next generation
deposition technology to enable larger commercial volumes. The final goal of this project is to prepare
and submit the clinical results for regulatory approval and reimbursement consideration for using
BioBridge as an interventional device for treating lymphedema.
Having a successful outcome at the completion of this study would provide a viable, safe and much
needed treatment approach to this common disease that so heavily impacts breast cancer survivorship.
It will also provide the framework for better comprehension of this disease and the role that regenerative
medicine can play in future strategies to treat and prevent lymphedema.

## Key facts

- **NIH application ID:** 10017167
- **Project number:** 5R44CA203608-05
- **Recipient organization:** FIBRALIGN CORPORATION
- **Principal Investigator:** David Woosuk Chang
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $32,935
- **Award type:** 5
- **Project period:** 2017-09-01 → 2022-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10017167

## Citation

> US National Institutes of Health, RePORTER application 10017167, Prospective evaluation of a surgical solution for breast cancer-associated lymphedema (5R44CA203608-05). Retrieved via AI Analytics 2026-05-21 from https://api.ai-analytics.org/grant/nih/10017167. Licensed CC0.

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