Company: XAIR
Filing Date: 2025-06-20
Form Type: 10-K
Source: 0001641172-25-015750
Chunk: 505

Company: Beyond Air, Inc.
Filing Date: 2025-06-20
Form: 10-K
Item: Item 1
Chunk 505
---
 150 ppm
NO and above, especially in the lungs, may have side effects and cause damage to host cells. Intermittent exposure to NO in cycles retains
NO anti-microbial activity both in vitro and in animal model of infection. Exposure of bacteria to concomitant 30-minute treatments with
160 ppm NO resulted in a significant reduction in bacterial load. A similar dose has been shown to reduce viruses (common influenza) by
30-100% in a canine kidney infection model. In vivo, in a pneumonia model in rats, inhaled 160 ppm NO, for 30 minutes, every 4 hours,
resulted in significant reduction in bacteria counts in the lungs, without affecting the body’s defense mechanisms, and without
any other adverse effect. In addition, we believe a daily dose of 160 ppm of NO can treat bovine respiratory disease (BRD) in cattle.

Importantly, several studies report
synergy between NO and antibiotic drugs. Adjunctive treatment combining NO together with inhaled tobramycin antibiotics or other anti-microbial
agents has been shown to greatly enhance the efficacy of the antibiotics in dispersing P. aeruginosa biofilms and to increase their
ability to elicit anti-microbial activity. These studies suggest that adjuvant treatment combining NO with antibiotics might have a beneficial
role by reducing bacterial infectivity, and therefore reduce the dependency on antibiotics.

Beyond Air Technology

We have developed the Beyond Air
NO generator and delivery system which we call LungFit®, a novel and precise delivery system that uses NO generated from
ambient air with a novel NO generator, the ionizer. Our system provides continuous monitoring and control of the gaseous content administered
during intermittent and continuous NO inhalation treatments, as well as a precise and reliable monitoring system that is able to monitor
patient status and alert medical staff to any adverse effects.

The LungFit® system
is innovatively designed to provide patients with a gaseous dose of NO (ranging from 0.5 ppm up to 400 ppm) combined with ambient air.
The gaseous blend is supplied to the patient via a ventilator, face mask, or similar apparatus. LungFit® is designed to
minimize the time that NO is mixed with oxygen and air. The system is also designed to continuously monitor inhaled NO concentration,
NO2 concentration and oxygen. A dedicated screen allows for monitoring of the gas mixture. Further, our approved product and
product candidates resemble other inhalation systems, making