Company: XAIR
Filing Date: 2025-06-20
Form Type: 10-K
Source: 0001641172-25-015750
Chunk: 1823

Company: Beyond Air, Inc.
Filing Date: 2025-06-20
Form: 10-K
Item: Item 7
Chunk 1823
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The following discussion and
analysis of our financial condition and results of operations should be read in conjunction with our consolidated financial statements
and related notes appearing elsewhere in this Annual Report on Form 10-K. This discussion and other parts of this Annual Report contain
forward-looking statements that involve risks and uncertainties, such as statements regarding our plans, objectives, expectations, intentions
and projections. Our actual results could differ materially from those discussed in these forward-looking statements. Factors that could
cause or contribute to such differences include, but are not limited to, those discussed in Item 1A “Risk Factors.”

Introduction

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; 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