Company: XAIR
Filing Date: 2025-06-20
Form Type: 10-K
Source: 0001641172-25-015750
Chunk: 750

Company: Beyond Air, Inc.
Filing Date: 2025-06-20
Form: 10-K
Item: Item 1A
Chunk 750
---
 amount may not be high enough to allow us to establish or maintain pricing sufficient to realize a return on our
investment.

There is significant uncertainty
related to the insurance coverage and reimbursement of newly approved products. In the U.S., there is no uniform system among payors for
making coverage and reimbursement decisions. In addition, the process for determining whether a payor will provide coverage for a product
or service may be separate from the process for setting the price or reimbursement rate that the payor will pay for the product or service
once coverage is approved. Payors may limit coverage to specific products or services on an approved list, or formulary, which might not
include all of the FDA-approved or -cleared products for a particular indication. In the U.S., the principal decisions about Medicare
coverage and reimbursement for new medical devices are typically made by the Centers for Medicare & Medicaid Services (“CMS”),
an agency within the U.S. Department of Health and Human Services, or Medicare contractors that process and pay claims, as CMS and/or
the contractors decide whether and to what extent a new device will be covered and reimbursed under Medicare. Private payors tend to,
but are not required to, follow the coverage and reimbursement policies established by CMS to a substantial degree. It is difficult to
predict what CMS or the Medicare contractors will decide with respect to reimbursement for products such as ours.

Outside the U.S., international
operations are generally subject to extensive governmental price controls and other market regulations, and we believe the increasing
emphasis on cost-containment initiatives in the EEA, Canada and other countries has and will continue to put pressure on the pricing and
usage of our approved product or product candidates. In many countries, the prices of medical products are subject to varying price control
mechanisms as part of national health systems. In general, the prices of medical devices under such systems are substantially lower than
in the U.S. Other countries allow companies to fix their own prices for medical products, but monitor and control company profits. Additional
foreign price controls or other changes in pricing regulation could restrict the amount that we are able to charge for our approved product
or product candidates. Accordingly, in markets outside the U.S., the reimbursement for our products may be reduced compared with the U.S.
and may be insufficient to generate commercially reasonable revenue and profits.

Moreover, increasing efforts by
governmental and third-party payors in the U.S. and abroad to cap or reduce healthcare costs may cause such organizations to limit both
coverage