A compact, low cost system for nitric oxide inhalation therapy

Whalen Biomedical Inc.
Organization Location: 
Lexington, MA USA

A recent UNICEF report states:  Pneumonia kills more children than any other disease  more then AIDS, malaria, and measles combined. Our focus is on the introduction of new technology that will make available proven and newly emerging treatments for a variety of respiratory disorders affecting infants in low resource settings.

Our approach is based on providing respiratory support with inhaled nitric oxide (NO). Nitric oxide was considered to be a highly toxic pollutant as recently as the 1980s. It is now recognized to be an important messenger molecule in mammalian physiology. Inhaled NO is currently used to treat approximately 25,000 patients per year in the US, including term infants with pulmonary hypertension and some pre-term infants with respiratory insufficiency. Inhaled NO dilates the pulmonary vessels, lowers pulmonary artery pressure, and restores ventilation/perfusion balance in the lungs without significantly affecting the systemic circulation or blood pressure. It is both safe and effective, but currently it is prohibitively expensive and rarely used in other than developed countries.

The system we are proposing will provide unlimited quantities of NO gas at clinically useful concentrations. Nitric oxide is conveniently produced from room air using a low-power electrical energy source (such as a battery). The system will be low in manufacturing cost and simple and safe to operate. A 4-year effort to develop, test, and obtain regulatory approval for the system is described that will allow us to provide the gas at minimal cost in low resource settings when it is needed.