Company: PFSA
Filing Date: 2025-09-17
Form Type: S-1/A
Source: 0001213900-25-088333
Chunk: 16

Company: Profusa, Inc.
Filing Date: 2025-09-17
Form: S-1/A
Chunk 16
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 a going concern. Our audited 2024 financial statements and unaudited June 30, 2025 interim financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities that may result from the outcome of this uncertainty. Our ability to continue as a going concern will require us to obtain additional funding. If we are unable to raise capital when needed or on acceptable terms, we could be forced to delay, reduce or eliminate certain of our operations, and our stockholders could lose all, or a significant portion, of their investment in us. 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. Since inception, we have devoted substantially all of our financial resources to developing our products and related services. We have financed our operations primarily through the issuance of equity and debt securities. We have incurred significant losses. The amount of our future net losses will depend, in part, on regulatory approval, 8 commercialization and on -goingdevelopment of our products and related services, the rate of our future expenditures and our ability to obtain funding through the issuance of our securities, strategic collaborations or grants. We expect to continue to incur significant losses for several years as we continue to commercialize our Lumee Oxygen and Glucose Platform and seek to develop and commercialize new products and services. We anticipate that our expenses will increase substantially if and as we: •continue to build our sales, marketing and distribution infrastructure to commercialize our products and services; •continue to develop our products and services; •as we continue to conduct clinical studies; •seek to identify, assess, acquire, license and/or develop other products and services and subsequent generations of our current products and services; •seek to maintain, protect and expand our intellectual property portfolio; •seek to attract and retain skilled personnel; and •support our operations as a public company. Our ability to generate future revenue from product and service sales depends heavily on our success in many areas, including, but not limited to: •launching and commercializing current and future products and services; •obtaining and maintaining marketing authorization with respect to each of our products and maintaining regulatory compliance throughout relevant jurisdictions; •maintaining clinical and economical value for end -usersand customers in changing environments