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

Potential to revolutionize nitric oxide therapy by eliminating need for cumbersome cylinders creating improved economics and safety in hospital setting

Will be subject to a 180-day review period by the FDA

Launch expected in 2Q 2021, pending approval

GARDEN CITY, N.Y., Nov. 11, 2020 (GLOBE NEWSWIRE) -- Beyond Air, Inc. (NASDAQ: XAIR), a clinical-stage medical device and biopharmaceutical company focused on developing inhaled nitric oxide (NO) for the treatment of patients with respiratory conditions, including serious lung infections and pulmonary hypertension, and gaseous NO (gNO) for the treatment of solid tumors, today 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.