Company: XAIR
Filing Date: 2025-06-20
Form Type: 10-K
Source: 0001641172-25-015750
Chunk: 951

Company: Beyond Air, Inc.
Filing Date: 2025-06-20
Form: 10-K
Item: Item 1B
Chunk 951
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 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; 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 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 nont