Company: PFSA
Filing Date: 2025-08-25
Form Type: 424B3
Source: 0001213900-25-080387
Chunk: 11

Company: Profusa, Inc.
Filing Date: 2025-08-25
Form: 424B3
Chunk 11
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 net proceeds from this offering to purchase Bitcoin, the price of which has been, and will likely continue to be, highly volatile. Risks Related to Our Business and Operations •We have substantial doubt about our ability to continue as a going concern, which may hinder our ability to obtain further financing. •We have a limited operating history on which to assess the prospects for our business and we have incurred losses since inception. We anticipate that we will continue to incur significant losses for at least the next several years as we continue to commercialize our existing products and services and seek to develop and commercialize new products and services. •We operate in a highly competitive market and face competition from large, well -establishedcompanies with significant resources, and, as a result, we may not be able to compete effectively. •We are subject to a variety of risks due to our international operations that could adversely affect our business, our operations or profitability and operating results. •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 expect the commercialization of the Lumee Oxygen Platform to generate nearly all our commercial revenue until we obtain regulatory approval for additional products. 6 •We depend upon third -partysuppliers and outsource to other parties, making us vulnerable to supply disruptions, suboptimal quality, noncompliance and/or price fluctuations, which could harm our business. Risks Related to Healthcare Industry Shifts and Changing Regulations •There is no guarantee that the FDA will grant 510(k) clearance or PMA approval of our products, and failure to obtain necessary clearances or approvals for our future products would adversely affect our ability to grow our business. •If we are unable to successfully complete the pre -clinicalstudies or clinical trials necessary to support additional PMA, De Novo, or 510(k) applications or supplements, we may be unable to commercialize our CGM systems under development, which could impair our business, financial condition and operating results. •Our products may cause or contribute to adverse medical events or be subject to failures or malfunctions that we are required to report to the FDA, and if we fail to do so, we would be subject to sanctions that could harm our reputation, business, financial condition and results of operations.