Company: XAIR
Filing Date: 2025-09-25
Form Type: S-3
Source: 0001493152-25-014967
Chunk: 7

Company: Beyond Air, Inc.
Filing Date: 2025-09-25
Form: S-3
Chunk 7
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 capable of generating NO from ambient air. The Company’s 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 in conjunction with ventilatory support and other appropriate agents. This condition is commonly referred to as persistent pulmonary hypertension of the newborn (“PPHN”). 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 either continuously or for a fixed amount of time at various flow rates and has the ability to either titrate dose on demand or maintain a constant dose. In July 2022, we commenced marketing LungFit ® PH in the United States for PPHN as a medical device.

On November 26, 2024, the Company received European CE mark approval of the LungFit PH ®system for the following:

| ● | The                                                                                                                                         
 treatment of infants >34 weeks gestation with hypoxic respiratory failure associated with clinical or echocardiographic                     
 evidence of pulmonary hypertension, in order to improve oxygenation and to reduce the need for extracorporeal membrane oxygenation;         
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| ● | 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 to heart surgery, in order to selectively decrease pulmonary arterial pressure and improve right ventricular 
 function                                                                                                                                    |

LungFit ®can be used to treat patients on ventilators that require NO, as well as patients with chronic or acute severe lung infections via delivery of NO at concentrations > 100 parts per million (ppm) through a breathing mask or similar apparatus. Furthermore, we believe that there is a high unmet medical need for patients suffering from certain severe lung infections that the LungFit ®platform can potentially address. The Company’s other areas of focus with the LungFit ®platform beyond PPHN are nontuberculous mycobacteria (“NTM”) lung infection and those with various severe lung infections with underlying chronic obstructive pulmonary disease (“COPD”). Our current product candidates will be subject to premarket reviews and approvals by the FDA,