Company: XAIR
Filing Date: 2025-06-20
Form Type: 10-K
Source: 0001641172-25-015750
Chunk: 785

Company: Beyond Air, Inc.
Filing Date: 2025-06-20
Form: 10-K
Item: Item 1A
Chunk 785
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 safety and efficacy. Such
increased costs and delays or failures could adversely affect our business, operating results and prospects.

Even if our products are approved
or cleared in the United States and CE marked in the EEA in the future, comparable regulatory authorities of additional foreign countries
must also approve the manufacturing and marketing of our products in those countries, should we desire to access those markets. Certification,
approval and clearance procedures vary among jurisdictions and can involve requirements and administrative review periods different from,
and greater than, those in the United States or the EEA, including additional preclinical studies or clinical trials. Any of these occurrences
may harm our business, financial condition and prospects significantly.

We may experience delays in obtaining a CE mark
in the EEA for our approved product due to possible EU MDR regulatory classification that differs from the FDA’s regulatory paradigm.

In the
EEA, we expect that, if approved, our products would be classified as a medical device. However, competent regulatory authorities in EEA
countries or notified bodies could disagree and consider our products to be a drug-delivery combination product composed of a medical
device and a medicinal product. In the EEA, drug-delivery systems can fall within the scope of the medical device legislation or the pharmaceutical
legislation depending on their combination with the relevant medicinal substance.

If our
device is considered as being intended to administer a medicinal product and our device and the medicinal product are placed on the market
in such a way that they form a single integral product which is intended exclusively for use in the given combination and which is not
reusable, that single integral product shall be governed by Directive 2001/83/EC and be subject to a marketing authorization. The medical
device part of the drug-delivery combination product would not need to be CE marked. However, the relevant general safety and performance
requirements set out in Annex I to the EU MDR would apply as far as the safety and performance of the device part of the single integral
product are concerned. As a result, we would need to pursue different regulatory pathways for placing our product on the EEA market which
may lead to additional costs and time.

53

We may find it difficult to enroll patients
in our clinical trials. Difficulty in enrolling patients could delay or prevent clinical trials of our product candidates.

Identifying and qualifying patients
to participate in clinical trials of our product candidates is critical to our success. The timing of our clinical trials depends in part
on the speed at which we can recruit