Beyond Air® Submits Premarket Approval Application to FDA for LungFit™† PH to Treat Persistent Pulmonary Hypertension of the Newborn

Beyond Air announced the submission of a premarket approval (PMA) application to the U.S. Food and Drug Administration (FDA) for its LungFit™ PH to treat persistent pulmonary hypertension of the newborn (PPHN). FDA guidelines allow for a 180-day review period for a PMA.

“The PMA filing for the LungFit™ PH system to treat PPHN is a significant milestone for our company, as it brings us one step closer to revolutionizing nitric oxide therapy by eliminating heavy, cumbersome nitric oxide cylinders. LungFit™ PH generates nitric oxide from ambient air and delivers it to a ventilator creating a safer and more convenient environment for patients and medical staff. Completing this PMA submission is the culmination of years of hard work and dedication from the Beyond Air team, and I am proud that we were able to achieve this despite the challenges of the ongoing COVID-19 pandemic. Pending approval, we anticipate a U.S. commercial launch for LungFit™ PH in the second quarter of 2021,” said Steve Lisi, Chairman and Chief Executive Officer of Beyond Air.

Beyond Air’s LungFit™* is a cylinder-free, phasic flow nitric oxide generator and delivery system and has been designated as a medical device by the FDA. The ventilator compatible version of the device can generate NO from ambient air on demand for delivery to the lungs at concentrations ranging from 1 part per million (ppm) to 80 ppm. The LungFit™ system could potentially replace large, high-pressure NO cylinders providing significant advantages in the hospital setting, including greatly reducing inventory and storage requirements, improving overall safety with the elimination of NO2 purging steps, and other benefits. The LungFit™ can also deliver NO at concentrations at or above 80 ppm for potentially treating severe acute lung infections in the hospital setting (e.g. COVID-19, bronchiolitis) and chronic, refractory lung infections in the home setting (e.g. NTM). With the elimination of cylinders, Beyond Air intends to offer NO treatment in the home setting.

* Beyond Air’s LungFit™ is not approved for commercial use. Beyond Air’s LungFit™ is for investigational use only. Beyond Air is not suggesting NO use over 80 ppm or use at home.

PPHN is a lethal condition and secondary to failure of normal circulatory transition at birth. It is a syndrome characterized by elevated pulmonary vascular resistance (PVR) that causes labile hypoxemia due to decreased pulmonary blood flow and right-to-left shunting of blood. Its incidence has been reported as 1.9 per 1000 live births (0.4–6.8/1000 live births) with mortality rate ranging between 4–33%. This syndrome complicates the course of about 10% of infants with respiratory failure and remains a source of considerable morbidity and mortality. NO gas is a vasodilator, is approved in dozens of countries to improve oxygenation and reduces the need for extracorporeal membrane oxygenation (ECMO) in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilator support and other appropriate agents.

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