Company: XAIR
Filing Date: 2025-11-10
Form Type: 10-Q
Source: 0001493152-25-021561
Chunk: 9

Company: Beyond Air, Inc.
Filing Date: 2025-11-10
Form: 10-Q
Item: Part I, Item 1
Chunk 9
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 U.S. Food and Drug Administration (“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, the Company 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. 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”). The Company’s
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.