Company: XAIR
Filing Date: 2025-06-20
Form Type: 10-K
Source: 0001641172-25-015750
Chunk: 549

Company: Beyond Air, Inc.
Filing Date: 2025-06-20
Form: 10-K
Item: Item 1
Chunk 549
---
OSYL DS for HRF associated with PPHN in 2019 and received FDA approval for a third generation of that delivery system
in 2023. In addition, other companies may be developing inhaled NO delivery systems at various concentrations. Novan Inc. has recently
received approval for a nitric oxide-based prescription treatment called berdazimer for molluscum, a contagious skin infection. SaNOtize
has an NO nasal spray that has received approval in India, Israel, and eight other countries for preventing COVID-19 after exposure. NovLead
Biotechnology (Nanjing, China) has approval in China for a device that produces nitric oxide through a process of passing an electric
charge into an electrolyte solution and Shenzhen Respomed Medical Technology (Shenzhen, China) also has approval in China for a device
that uses electrical discharge to generate nitric oxide gas. Neither of these devices have approval outside of China. Third Pole has reported
the development of an NO generator and delivery system, but we are not aware of any display of any product at any medical/scientific conference
in recent years. Our patents surrounding LungFit® have priority date over those of Third Pole.

In addition to NO treatments currently
available or under development, we also face competition from non-NO-based drugs and therapies. For example, the successful development
of immunizations for bronchiolitis may render useless any product we develop for that indication. Also, antibiotic treatments for infections
associated with CF and other underlying lung conditions may be preferred over any product that we develop. Even if we successfully develop
our product candidates, and obtain certification or approval for them, other treatments may be preferred and we may not be successful
in commercializing our product candidates.

Some of our competitors have substantially
greater financial, technical and other resources, such as larger research and development staff and experienced marketing and manufacturing
organizations. Additional mergers and acquisitions in the medical device, biotechnology and pharmaceutical industries may result in even
more resources being concentrated in our competitors. As a result, these companies may obtain certification or regulatory approval more
rapidly than we are able to and may be more effective in selling and marketing their products as well. Smaller or early-stage companies
may also prove to be significant competitors, particularly through collaborative arrangements with large, established companies. Competition
may increase further as a result of advances in the commercial applicability of technologies and greater availability of capital for investment
in these industries. Our competitors may succeed in