Company: XAIR
Filing Date: 2025-06-20
Form Type: 10-K
Source: 0001641172-25-015750
Chunk: 1202

Company: Beyond Air, Inc.
Filing Date: 2025-06-20
Form: 10-K
Item: Item 2
Chunk 1202
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® 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 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, certification through the conduct of a conformity assessment by a notified body in the EU for the
product to be CE marked, as well as comparable foreign regulatory authorities.

In addition to the above-mentioned
programs, we have two subsidiaries that are currently engaging in novel preclinical stage pharmaceutical research, Beyond Cancer and NeuroNos.

Financial Operations Overview

Critical Accounting Estimates

Our management’s discussion
and analysis of our financial condition and results of operations is based on our consolidated financial statements, which have been prepared
in accordance with U.S. generally accepted accounting principles (“GAAP”). The preparation of our consolidated financial statements
and related disclosures requires us to make estimates, assumptions and judgments that affect the reported amount of assets, liabilities,
costs and expenses and related disclosures.