Beyond Air, Inc.

We are a commercial-stage medical device and biopharmaceutical company that develops nitric oxide ("NO") generators and delivery systems, known as the LungFit® platform, which can generate NO from ambient air. Our first device, LungFit® PH, received premarket approval ("PMA") from the FDA in June 2022. The NO generated by the LungFit® PH system is indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension, commonly called persistent pulmonary hypertension of the newborn ("PPHN"), when used with ventilatory support and other appropriate agents. The LungFit® platform can generate NO up to 400 parts per million ("ppm") for delivery to a patient's lungs directly or via a ventilator. LungFit® can deliver NO continuously or for a fixed amount of time at various flow rates, and can either titrate dose on demand or maintain a constant dose. In September 2022, we began marketing LungFit® PH in the United States for PPHN as a medical device. On November 26, 2024, the Company received European CE mark approval for the LungFit PH® system for treating infants > 34 weeks gestation with hypoxic respiratory failure associated with pulmonary hypertension to improve oxygenation and reduce the need for extracorporeal membrane oxygenation. It is also approved for treating 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. LungFit® can treat patients on ventilators requiring NO, and patients with chronic or acute severe lung infections by delivering NO at concentrations > 100 ppm through a breathing mask or similar apparatus.