Company: PFSA
Filing Date: 2025-08-22
Form Type: S-1/A
Source: 0001213900-25-079829
Chunk: 35

Company: Profusa, Inc.
Filing Date: 2025-08-22
Form: S-1/A
Chunk 35
---
: •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 how these products and technologies compare to each other. This lack of information may result in consumers purchasing devices from our competitors, even if our product would provide consumers with their desired product features. In addition, any adverse events or safety issues relating to competitive products and related negative publicity, even if such events are not attributable to our products, could result in reduced purchases of our products by consumers generally. Any of these occurrences could lead to reduced sales of our products and adversely affect our business, financial condition and results of operations. We expect the commercialization of the Lumee Oxygen Platform to generate nearly all our commercial revenue until we obtain regulatory approval for additional products. Our first offering is the Lumee Oxygen Platform, from which we expect to continue to derive nearly