SBIR-STTR Award

Direct to Phase II

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 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 V 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 healthy volunteers and to date patients with PAH in the MGH catheterization lab Third Pole and the Zapol lab have commenced work under NHLBI B BIC NCAI grant U HL 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 Narrative Nitric Oxide is a selective pulmonary vasodilator that was approved in 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