Company: PFSA
Filing Date: 2025-08-11
Form Type: S-1
Source: 0001213900-25-073872
Chunk: 168

Company: Profusa, Inc.
Filing Date: 2025-08-11
Form: S-1
Chunk 168
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 issued ASU No. 2024 -03(“ASU 2024 -03”), Disaggregation of Income Statement Expenses (“DISE”). ASU 2024 -03requires disaggregated disclosure of income statement expenses for public business entities. ASU 2024 -03does not change the expense captions an entity presents on the face of the income statement; rather, it requires disaggregation of certain expense captions into specified categories in disclosures within the footnotes to the financial statements. As revised by ASU No. 2025 -01, Income Statement — Reporting Comprehensive Income — Expense Disaggregation Disclosures, the provisions of ASU 2024 -03are effective for fiscal years beginning after December 15, 2026, and interim periods within fiscal years beginning after December 15, 2027, with early adoption permitted. With the exception of expanding disclosures to include more granular income statement expense categories, the Company does not expect the adoption of ASU 2024 -03to have a material effect on our consolidated financial statements taken as a whole.

106 BUSINESS Overview Profusa is a digital health technology company based in Berkeley, CA, that has invested over the last twelve years more than $100 million from sophisticated venture investors as well as the most sophisticated research institutions in the U.S. (including approximately $30 million from Defense Advance Research Projects Agency, or DARPA, and the National Institutes of Health, of NIH) to develop a unique biosensor platform that is easily injected subcutaneously to provide, for the first time, real -time, individual biochemistry, that is cost effective while functioning for more than six times longer than known best in class solutions on the market today. Profusa’s Lumee™ technology does not consist of a single product, but is rather a platform that can potentially launch products for multiple applications. Profusa’s overall strategy has been to robustly invest and therefore develop and protect its technology as a private company, first in Europe where the barriers to regulatory approval traditionally are not as great as they are in the U.S. Accordingly, Profusa has validated its technology and gained approval of its first product, Lumee Oxygen, with CE approval in the EU and in the process of migrating to meet new MDR requirements in Europe. In 2026 Profusa plans to launch this product, if approved by FDA, for sophisticated wound care management through a partner with distribution, sales and in -servicingexperience. The accessible markets for Profusa’s technology are not limited to U.S. and