Company: XAIR
Filing Date: 2025-08-12
Form Type: 10-Q
Source: 0001641172-25-023243
Chunk: 43

Company: Beyond Air, Inc.
Filing Date: 2025-08-12
Form: 10-Q
Item: Part I, Item 1
Chunk 43
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 publicly update or revise any forward-looking statements contained
herein, whether as a result of any new information, future events, changed circumstances or otherwise.

Beyond
Air, Inc., the Beyond Air logo, and other trademarks or service marks of Beyond Air, Inc. appearing in this Form 10-Q are the property
of Beyond Air, Inc. This Form 10-Q also includes trademarks, tradenames and service marks that are the property of other organizations.
Solely for convenience, trademarks and tradenames referred to in this Form 10-Q appear without the ® and ™ symbols,
but those references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our
rights, or that the applicable owner will not assert its rights, to these trademarks and tradenames.

23

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 extr