Company: PFSA
Filing Date: 2025-08-25
Form Type: 424B3
Source: 0001213900-25-080387
Chunk: 31

Company: Profusa, Inc.
Filing Date: 2025-08-25
Form: 424B3
Chunk 31
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 revenues in international countries. We currently operate clinical trial studies internationally in Vietnam, Germany and Austria and intend to continue to pursue growth opportunities outside the United States and we may increase our use of administrative and support functions from locations outside the United States, which could expose us to greater risks associated with our sales and operations. As we pursue opportunities outside the United States, we may become more exposed to these risks and our ability to scale our operations effectively may be affected. Additionally, our international expansion efforts may not be successful and we may experience difficulties in scaling these functions from locations outside the United States and may not experience the expected cost efficiencies. Our profitability and international operations are, and will continue to be, subject to a number of risks and potential costs, including: •local product preferences and product requirements; 19 •longer payment cycles and difficulties in enforcing agreements and collecting receivables through certain foreign legal systems; •fluctuations in foreign currency exchange rates; •less intellectual property protection in some countries outside the United States than exists in the United States; •trade protection measures and import and export licensing requirements; •trade relations among the United States and foreign countries in which our customers or future customers, distributors, manufacturers and suppliers may have operations; •required compliance with foreign regulatory requirements and laws; •required compliance with anti -briberylaws, such as the U.S. Foreign Corrupt Practices Act, data privacy requirements, labor laws and anti -competitionregulations; •workforce instability; •political and economic instability; and •the potential impact of tariffs and the resulting impact of administration changes in the U.S. government. Changes in foreign currency exchange rates may reduce the reported value of our foreign currency denominated revenues, expenses, and cash flows. We cannot predict changes in currency exchange rates, the impact of exchange rate changes, nor the degree to which we will be able to manage the impact of currency exchange rate changes. There are a variety of oxygen monitoring and CGM products and technologies, and consumer confusion about product features and technology could lead consumers to purchase competitive products instead of our products, or to conflate any adverse events or safety issues associated with oxygen monitoring and CGM products with our products, which could adversely affect our business, financial condition and results of operations. We believe that many individuals do not have full information regarding the types of oxygen monitoring and CGM products and available in the market, in part due to the lack of consumer education regarding these types of products. Consumers may not have sufficient information about oxygen monitors or CGMs generally or