Company: XAIR
Filing Date: 2025-06-20
Form Type: 10-K
Source: 0001641172-25-015750
Chunk: 506

Company: Beyond Air, Inc.
Filing Date: 2025-06-20
Form: 10-K
Item: Item 1
Chunk 506
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 them user friendly, with operation and maintenance that we believe will be
immediately familiar to medical staff. Our LungFit® system has been manufactured at commercial scale with a contract manufacturer.

13

When programmed for lung infections,
the LungFit®, is designed to specifically deliver  NO at concentrations of 150 ppm and higher. We believe that the LungFit®
has a number of advantages over other NO formulation delivery systems. For example, it is:

    ● 
    optimized to deliver 150 ppm and higher of NO, whereas existing NO delivery systems on the market consist of a maximum deliverable NO concentration of 80 ppm;

    ● 
    equipped with a monitoring system that continuously monitors system parameters (e.g., NO, NO2 and inhaled fraction of inspired oxygen (“FiO2”) concentrations); 

    ● 
    capable of providing constant flow of NO, which we believe allows it to adequately cover the surface area of the lung to eliminate bacteria, viruses, fungi and other microbes;

    ● 
    programmable and able to deliver different dosage regimens for a wide range of lung infections;

    ● 
    able to generate NO from ambient air, eliminating the need for the use of high-pressure cylinders;

    ● 
    designed to be used by the patient, thus convenient and portable; and

    ● 
    administered non-invasively through a facial mask, which has the potential to address severe infections in large, underserved chronic-care markets, such as CF and COPD.

We believe that our solution has
the potential for a number of additional benefits and opportunities, as follows:

    ● 
    The antimicrobial and multiple other properties of the NO molecule delivered to the lungs suggest the potential for application in a wide range of respiratory diseases. In contrast to the often arduous and slow drug discovery process for small molecules, proteins, and peptides, the use of NO in medicine is well-known, and therefore the identification of conditions where NO provides benefits has been, and we expect will continue to be, much simpler, quicker and less costly.

    ● 
    The FDA approved the use of NO as an inhaled drug for the treatment of PPHN in 1999. More than 20 years of clinical experience in the delivery, monitoring and understanding of NO in the clinical environment for vascular uses has been documented.

    ● 
    NO is naturally produced by the immune system and acts as a first line of defense against infectious diseases. We believe therapeutic use of NO for viral and bacterial co-infections would potentially