Company: XAIR
Filing Date: 2025-06-20
Form Type: 10-K
Source: 0001641172-25-015750
Chunk: 492

Company: Beyond Air, Inc.
Filing Date: 2025-06-20
Form: 10-K
Item: Item 1
Chunk 492
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 Beyond Air
reorganized its neurology business into a new private company called NeuroNOS Limited (“NeuroNOS”). Beyond Air’s infrastructure,
for example regulatory, quality, legal, etc, will continue to support the NeruoNOS team. Beyond Air has 88.2% ownership in NeuroNOS.

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Our approved product and active
pipeline of product candidates is shown in the tables below:

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LungFit® PH is
the first FDA-approved system using our patented plasma pulse technology to generate on-demand NO from ambient air and, regardless of
dose or flow, deliver it to a ventilator circuit. The device uses a medical air compressor to drive room air through a plasma chamber
in the center of the unit where pulses of electrical discharge are created between two electrodes. The system uses the power equivalent
to a 60-watt lightbulb 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 logistics and 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