Company: PFSA
Filing Date: 2025-10-29
Form Type: 424B3
Source: 0001213900-25-103174
Chunk: 314

Company: Profusa, Inc.
Filing Date: 2025-10-29
Form: 424B3
Chunk 314
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 closing
of the Merger, there continue to be factors which raise substantial doubt about the Company’s ability to continue as a going concern
within one year from the date the condensed consolidated financial statements are issued. The condensed consolidated financial statements
do not contain any adjustments that might result from the outcome of this uncertainty.

Significant Risks and Uncertainties

The Company operates in a
dynamic and highly competitive industry and believes that changes in any of the following areas could have a material adverse effect on
the Company’s future financial position, results of operations, or cash flows: ability to obtain future financing; advances and
trends in new technologies and industry standards; results of clinical trials; regulatory approval and market acceptance of the Company’s
products; development of sales channels; certain strategic relationships; litigation or claims against the Company based on intellectual
property, patent, product, regulatory, or other factors; and the Company’s ability to attract and retain employees necessary to
support its growth.

Products developed by the
Company require approvals from the U.S. Food and Drug Administration (“FDA”) or other international regulatory agencies
prior to commercial sales. There can be no assurance that the products will receive the necessary approvals. If the Company is denied
approval, approval is delayed or the Company is unable to maintain approval, it could have a materially adverse impact on the Company.

The Company has expended and will continue to
expend substantial funds to complete the research, development and clinical testing of product candidates. The Company also will be required
to expend additional funds to establish commercial-scale manufacturing arrangements and to provide for the marketing and distribution
of products that receive regulatory approval. For any periods after the twelve months subsequent to the filing of these financial
statements as of June 30, 2025, the Company may be required to seek additional equity or debt financing to commercialize its products.

<div align='center'>F-35

PROFUSA, INC. AND SUBSIDIARY
NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)</div>

Note 1 — Organization, Description of Business, Going Concern and Significant Risks and Uncertainties(cont.)

If adequate funds are unavailable on a timely
basis from operations or additional sources of financing, the Company may have to delay, reduce the scope of or eliminate one or more
of its research or development programs which would materially and adversely affect its business, financial condition and results of
operations.

Inflation, Monetary Response, and Economic Imp