Beyond Air, Inc.

Beyond Air, Inc. is a commercial-stage medical device and biopharmaceutical company that develops a platform of nitric oxide (NO) generators and delivery systems, known as the LungFit® platform. This platform is designed to generate NO from ambient air. The company's initial device, LungFit® PH, received premarket approval (PMA) from the FDA in June 2022. The NO produced by the LungFit® PH system is approved to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term neonates (greater than 34 weeks gestation) who have hypoxic respiratory failure linked to clinical or echocardiographic evidence of pulmonary hypertension, when used with ventilatory support and other suitable agents. This condition is commonly referred to as persistent pulmonary hypertension of the newborn (PPHN). The LungFit® platform can generate NO at concentrations up to 400 parts per million (ppm) for delivery to a patient's lungs, either directly or through a ventilator. LungFit® can deliver NO continuously or for a set duration at various flow rates, and it can either adjust the dose on demand or maintain a constant dose. Beyond Air, Inc. began marketing LungFit® PH in the United States for PPHN as a medical device in July 2022. In November 2024, the company received European CE mark approval for the LungFit PH® system for two indications: the treatment of infants greater than 34 weeks gestation with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension, to improve oxygenation and reduce the need for extracorporeal membrane oxygenation; and the treatment of peri- and post-operative pulmonary hypertension in adults and newborn infants, infants and toddlers, children and adolescents, ages 0-17 years, in conjunction with heart surgery, to selectively decrease pulmonary arterial pressure and improve right ventricular function and oxygenation. LungFit® can be used for patients on ventilators who require NO, as well as for patients with chronic or acute severe lung infections, by delivering NO at concentrations greater than 100 ppm through a breathing mask or similar device.