Company: XAIR
Filing Date: 2025-02-10
Form Type: 10-Q
Source: 0001493152-25-005678
Chunk: 156

Company: Beyond Air, Inc.
Filing Date: 2025-02-10
Form: 10-Q
Item: Part I, Item 2
Chunk 156
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b to ionize the nitrogen and oxygen molecules, which then combine as NO with
low levels of nitrogen dioxide (“NO2”) created as a byproduct. The products are then passed through a Smart
Filter, which removes the toxic NO2 from the internal circuit. With respect to PPHN, the novel LungFit® PH
is designed to deliver a dosage of NO to the lungs that is consistent with current guidelines for delivery of 20 ppm NO with a range
of 0.5 ppm – 80 ppm (low concentration NO) for ventilated patients.

We
believe the ability of LungFit® PH to generate NO from ambient air provides us with many competitive advantages over the
current standard of NO delivery systems in the U.S., the EU, Japan and other markets. For example, LungFit® PH does not
require the use of a high-pressure cylinder, does not require cumbersome purging procedures and places less burden on hospital staff
in carrying out safety procedures.

Our
novel LungFit® platform can also deliver a high concentration (>150 ppm) of NO directly to the lungs, which
we believe has the potential to eliminate microbial infections including bacteria, fungi and viruses, among others. We believe that current
FDA-approved NO vasodilation treatments would have limited success in treating microbial infections given the low concentrations of NO
being delivered (<100 ppm). Given that NO is produced naturally by the body as an innate immunity mechanism, at a concentration of
200 ppm, supplemental high dose NO should aid in the body’s fight against infection. Based on our preclinical studies and clinical
trials, we believe that 150 ppm is the minimum therapeutic dose to achieve the desired pulmonary antimicrobial effect of NO. To date,
neither the FDA nor comparable foreign regulatory agencies in other countries or regions have approved any NO formulation and/or delivery
system for >80 ppm NO.

LungFit®
PH for the treatment of Persistent Pulmonary Hypertension of the Newborn (PPHN)

In
June 2022, the FDA approved LungFit® PH 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. LungFit® PH is
the inaugural device from the LungFit® platform of NO generators that use patented ionizer technology and is the first
FDA