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

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ABSTRACT Funding is requested to support essential steps required to commercialize 3P-001, a medical device that generates medical grade nitric oxide (NO) from air. NO is a pulmonary vasodilator to treat hypoxic respiratory failure (HRF) in neonates (blue babies) and pulmonary hypertension in patients having cardiothoracic surgery (CTS). Third Pole’s value proposition is that availability of a tank-less iridium-electrode NO generator will greatly expand the use of inhaled nitric oxide (iNO) therapy to treat HRF (approved in both the USA and EU) and during CTS (approved in the EU). The goal is to replace use of pressurized tanks of NO in N2 as the source of medical grade NO. The current tank system requires prolonged set-up times and a complicated supply chain. 3P-001 is tank-less, requiring only electricity and air to produce medical grade NO. It can be deployed quickly and easily (plug and play). The aims of this Phase IIB Bridging Award Application are: Aim 1: Validate 3P-001 for use with commonly-used ventilators and other devices. 3P-001 will be tested with an expanding list of pediatric and adult ventilators for regulatory submission. It will also be validated for use with anesthesia machines, artificial manual breathing units, nasal cannulas, masks, through bench testing for safety and effectiveness of NO delivery. Aim 2: Perform a clinical study in HRF to evaluate safety and effectiveness. It is anticipated that the EU authorities will require a study evaluating safety and effectiveness in patients with HRF, while FDA does not currently require a clinical study in HRF for market authorization. The study will also promote market adoption. This study will be planned and implemented with the help of InClin, a contract research organization (CRO). Aim 3: Perform a clinical study in adult cardiothoracic surgery to evaluate safety and effectiveness. iNO is frequently used during heart/lung transplantation, valve surgery and left ventricular assist device implantation. It is anticipated that the EU authorities will require a cardiac surgery study. This will also address potential FDA concern about safety of 3P-001 use in cardiac surgery, the most common clinical use worldwide, and also promote market adoption in the EU. This study will be planned and implemented with the help of InClin. Aim 4: Validate the 3P-001 ambulatory device for transportation. This is vital to exploit the advantages of 3P-001 for patient transport by land and/or air. Studies will include subjecting 3P-001 to environmental challenges such as acceleration, vibration, altitude, temperature and impact to confirm that the device remains safe and functions as intended using parameters defined by a variety of validating agencies.