# Endobronchial Supervalve for the Treatment of Emphysema

> **NIH NIH R44** · CORIDEA, LLC · 2021 · $805,212

## Abstract

PROJECT SUMMARY
In the United States, COPD ranks third in causes of mortality with 100,000 deaths annually. An estimated 15
million people had health care provider diagnosed COPD in 2010, and an estimated 12 million potential cases
remain undiagnosed. Emphysema is a progressive, incurable form of COPD that causes significant morbidity
and mortality. Emphysema is characterized by the loss of lung elasticity, reduced expiratory flow and
hyperinflation. Lung volume reduction surgery is known to be an effective option for patients with moderate-
severe emphysema, but few patients qualify due to the invasiveness of the procedure. Minimally invasive
endobronchial lung volume reduction using one-way valves has recently been developed to address this
unmet need and was approved by the FDA as recently as 2018.
This proposal will validate a new, next generation Super Valve for endobronchial lung volume reduction that
will broaden the use of this approach to treat patients with emphysema. Our innovation exploits the anatomy
of the lobar segments of the lungs to achieve lung volume reduction using a single site instead of 3-6 sites
required by the current methods. This, in turn, will lead to a faster and more efficient procedure, reducing
overall surgical time and costs.
This project will be completed in several sequential stages. For Phase I we will finalize concept selection for
the valve design and demonstrate proof of technical concept on the bench and in acute preclinical studies
that our Super Valve can be deployed in lobar airways and that it can withstand physiological stresses. In
Phase II of this proposal we mature the Valve design for chronic implantation by developing features that
ensure an air-tight seal and prevent migration in the setting of normal respiration and cough. We will then
verify and validate a human grade valve system to FDA standards and ensure it is safe for implantation over
the lifetime of the patient. The safety and durability of our valves will be demonstrated in chronic preclinical
studies. The results obtained in Phase II will be used to support pre-IDE meeting with the FDA.

## Key facts

- **NIH application ID:** 10274726
- **Project number:** 4R44HL149550-02
- **Recipient organization:** CORIDEA, LLC
- **Principal Investigator:** Mark Gelfand
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $805,212
- **Award type:** 4N
- **Project period:** 2020-12-01 → 2022-11-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10274726

## Citation

> US National Institutes of Health, RePORTER application 10274726, Endobronchial Supervalve for the Treatment of Emphysema (4R44HL149550-02). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10274726. Licensed CC0.

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