Company: XAIR
Filing Date: 2025-06-20
Form Type: 10-K
Source: 0001641172-25-015750
Chunk: 554

Company: Beyond Air, Inc.
Filing Date: 2025-06-20
Form: 10-K
Item: Item 1
Chunk 554
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 modify
or invalidate the ACA or its implementing regulations, or portions thereof, will affect our business. Additional legislative changes,
regulatory changes and judicial challenges related to the ACA remain possible. We cannot predict what effect further changes related to
the ACA would have on our business.

We cannot be sure whether additional
legislative changes will be enacted, or whether government regulations, guidance or interpretations will be changed, or what the impact
of such changes would be on the certification or marketing approvals, sales, pricing, or reimbursement of our approved product or product
candidates, if any, may be. We expect that any such healthcare reform measures that may be adopted in the future, may result in more rigorous
coverage criteria and in additional downward pressure on the price that we receive for any approved product. Any reduction in reimbursement
from Medicare or other government programs may result in a similar reduction in payments from private payors. The implementation of cost
containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability, or commercialize
our approved product or product candidates.

Moreover, in order to obtain reimbursement
for our products in some EEA countries, including some EU Member States, we may be required to compile additional data comparing the cost-effectiveness
of our products to other available therapies. Health Technology Assessment (“HTA”) of both medicinal products and medical
devices is becoming an increasingly common part of the pricing and reimbursement procedures in some EU Member States, including those
representing the larger markets. The HTA process, which is currently governed by national laws in each EU Member State, is the procedure
to assess therapeutic, economic and societal impact of a given medical product in the national healthcare systems of the individual country.
The outcome of an HTA will often influence the pricing and reimbursement status granted to these medical products by the competent authorities
of the respective EU Member State. The extent to which pricing and reimbursement decisions are influenced by the HTA of the specific medical
product currently varies between EU Member States. On December 13, 2021, the EU adopted a new HTA Regulation which entered into force
on January 11, 2022 and will become applicable to all EU Member States from January 12, 2025. The new EU HTA regulation aims to harmonize
the clinical benefit assessment of HTA across the EU and provides the basis for permanent and sustainable cooperation at the EU level
for joint clinical assessments in these areas.

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We are subject to additional federal and state