Company: XAIR
Filing Date: 2025-02-10
Form Type: 10-Q
Source: 0001493152-25-005678
Chunk: 19

Company: Beyond Air, Inc.
Filing Date: 2025-02-10
Form: 10-Q
Item: Part I, Item 1
Chunk 19
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IES

NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

NOTE
2 SIGNIFICANT ACCOUNTING POLICIES AND OTHER RISKS AND UNCERTAINTIES (continued)

Other
Risks and Uncertainties

The
Company is subject to risks common to development and early-stage medical device companies including, but not limited to, new technological
innovations, certifications or regulatory approval, dependence on key personnel, protection of proprietary technology, compliance with
government regulations, product liability, uncertainty of market acceptance of approved products and the potential need to obtain additional
financing. The Company is also dependent on third-party suppliers and, in some cases, single-source suppliers.

The
Company’s products require approval or clearance from the FDA prior to commencement of commercial sales in the United States. There
can be no assurance that the Company’s products beyond LungFit® PH in the U.S. will receive the required approvals
or clearances. Certifications, approvals or clearances are also required in foreign jurisdictions in which the Company may license or
sell its products. If the Company is denied such certifications or approvals or clearances or such certifications, approvals or clearances
are delayed, such denial or delay may have a material adverse impact on the Company’s results of operations, financial position
and liquidity. Further, there can be no assurance that the Company’s product will be accepted in the marketplace, nor can there
be any assurance that any future products can be developed or manufactured at an acceptable cost and with appropriate performance characteristics,
or that such products will be successfully marketed, if at all.

Lease
Revenue Recognition

The
Company generates revenue from the leases of its LungFit® PH devices to its customers under fixed fee arrangements over periods of
up to three years. The fixed fee is typically broken down into ratable monthly payments over the term of the arrangement. The Company’s
customers include hospitals and medical facilities. The Company’s LungFit® PH leases include filters, calibration gas, bagging
kits, cables, adapters, and other components and accessories required to use the LungFit® PH device (the “Consumables”).
The Consumables’ quantities are varied and may be supplied upon demand of the customers and are unlimited, or the arrangement may
provide for the maximum quantities available to the customer over the term of the arrangement. The Company’s LungFit® PH leases
also include maintenance and training required to use the LungFit® PH device, as well as