We propose to design and test a lightweight iridium-electrode nitric oxide generator that provides medical grade NO gas from air and electricity, to serve as an economical, portable, battery-driven source of NO for ambulatory and home inhalation therapy. These features will make it feasible to conduct robust outpatient trials leading to a novel selective pulmonary vasodilator therapy for chronic lung disease and heart failure. Inhaled NO produces pulmonary vasodilation without systemic vasodilation, which is a significant issue with other currently available therapies. In December 1999, the US Food and Drug Administration (FDA), approved inhaled NO for the treatment of hypoxic term or near-term infants with hypoxic respiratory failure (HRF) since which time inhaled NO has been a life-saving intervention for hospitalized infants to treat acute pulmonary hypertension. However tank-delivered NO is not practical for portable applications due to its weight and complexity of delivery. Our technology will enable inhaled NO as a portable therapy for these debilitating chronic diseases. Our collaborators in the Zapol lab at MGH recently reported on data obtained from testing a 110V AC-powered bedside NO generating device in a lamb model of pulmonary artery hypertension (PAH). This prototype was subsequently tested in a human proof of concept (POC) trial in 6 healthy volunteers and to date 5 patients with PAH in the MGH catheterization lab. Third Pole and the Zapol lab have commenced work under NHLBI B-BIC/NCAI grant #U54HL119145 to optimize the electrode design of an NO generator for use with mechanical ventilators and anesthesia machines. We will gather user requirements, test and develop a battery-powered portable iridium electrode inhaled NO generator with optimal materials and design to enable trials of safe long-term ambulatory inhalation therapy with NO.

Public Health Relevance

Nitric Oxide is a selective pulmonary vasodilator that was approved in 1999 in the US to treat neonates that are born blue - with Hypoxic Respiratory Failure. The therapy remains expensive and difficult to use. Third Pole is developing technology to make Nitric Oxide from air- enabling access to the medicine worldwide and opening up new portable uses.

Agency
National Institute of Health (NIH)
Institute
National Center for Advancing Translational Sciences (NCATS)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
1R44TR001704-01
Application #
9199541
Study Section
Special Emphasis Panel (ZRG1-CVRS-H (11)B)
Program Officer
Purucker, Mary E
Project Start
2016-08-15
Project End
2018-07-31
Budget Start
2016-08-15
Budget End
2017-07-31
Support Year
1
Fiscal Year
2016
Total Cost
$1,073,276
Indirect Cost
Name
Third Pole, Inc.
Department
Type
DUNS #
079908607
City
San Francisco
State
CA
Country
United States
Zip Code
94122