Iridium electrode inhaled Nitric Oxide generator for treatment of hypoxic respiratory failure in neonates

Abstract We propose to develop a medical device building on an existing clinical prototype that generates medical grade nitric oxide NO from air for inhalation An iridium electrode inhaled NO generator will supersede existing devices which utilize NO cylinder supply chains and complex bedside administration systems and vastly increase worldwide access to this lifesaving pediatric selective pulmonary vasodilator 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 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 develop an iridium electrode NO generator with expert clinician input under FDA design controls which will serve as a basis for clinical bioequivalence studies anticipated to be required for regulatory approval Development in the academic setting has not yet been conducted under formal FDA design controls a requirement for obtaining IDE status and entering broader clinical trials An iridium electrode inhaled NO generator with optimal materials and design will enable worldwide provision of NO inhalation therapy for infants with HRF 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