Company: XAIR
Filing Date: 2025-11-21
Form Type: S-1
Source: 0001493152-25-024614
Chunk: 6

Company: Beyond Air, Inc.
Filing Date: 2025-11-21
Form: S-1
Chunk 6
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'>PROSPECTUS SUMMARY</div>

This summary highlights information contained elsewhere in this prospectus. This summary is not complete and does not contain all of the information you should consider in making your investment decision. You should carefully read the entire prospectus, including the risks of investing in our securities discussed under the heading “Risk Factors” and under similar headings in the other documents that are incorporated by reference into this prospectus. You should also carefully read the information incorporated by reference into this prospectus, including our financial statements, and the exhibits to the registration statement of which this prospectus is a part.

Overview

We are a commercial-stage medical device and biopharmaceutical company developing a platform of nitric oxide (“NO”) generators and delivery systems (the “LungFit ®platform”) 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