Company: PFSA
Filing Date: 2025-11-19
Form Type: 10-Q
Source: 0001213900-25-112723
Chunk: 14

Company: Profusa, Inc.
Filing Date: 2025-11-19
Form: 10-Q
Item: Part I, Item 1
Chunk 14
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 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. As of September 30, 2025, the Company may be required to seek additional equity or debt financing to commercialize
its products. 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 Impacts

The world economy is experiencing stubbornly high inflation, a challenge
not faced for decades. Following the global financial crisis, with inflationary pressures muted, interest rates were extremely low for
years and investors became accustomed to low volatility. The resulting easing of financial conditions supported economic growth, but it
also contributed to a buildup of financial vulnerabilities. With inflation at multi-decade highs, monetary authorities in advanced economies
are accelerating the pace of policy normalization. Policymakers have continued to tighten policy against a backdrop of rising inflation
and currency pressures, albeit with notable differences across regions. Global financial conditions have tightened notably this year,
leading to capital outflows. Amid heightened economic and geopolitical uncertainties, investors have aggressively pulled back from risk-taking
and adjusted their investment preferences generally. Key gauges of systemic risk, such as higher dollar funding costs and counterparty
credit spreads, have risen. There is a risk of a disorderly tightening of financial conditions that may be amplified by vulnerabilities
built over the years.

In addition, our business, growth, financial condition or results of
operations could be materially adversely affected