Company: PFSA
Filing Date: 2025-04-28
Form Type: S-4/A
Source: 0001213900-25-035718
Chunk: 291

Company: Profusa, Inc.
Filing Date: 2025-04-28
Form: S-4/A
Chunk 291
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KOLs) in the United States and European Union. Profusa already has worked with European physicians and other individuals considered by Profusa to be KOLs as part of clinical trials, which served as basis for CE mark attainment of Wireless Lumee Oxygen Platform, as well as ongoing efforts in the United States. Lumee Oxygen will first be launched at large -volumecenters and then at smaller volume centers, followed by ambulatory care centers and doctors’ offices.

143 •Profusa’s revenue assumptions on the Lumee Oxygen rely on its ability to consummate distribution network in markets where they launch products. The approach of utilizing established distributors is expected to control its sales and market expense by limiting the sales team size required to gain access to these clinics as well as cost of commercial operations. These distributors have established sales footprint, commercial relationships with clinics and users that are currently unknown to Profusa, as well as the logistics infrastructure to manage the order -to-cashprocess and physical movement of products from the US to the markets. There will potentially be significant impact on Profusa’s revenue projections if the distributor network is not established. The impact can be up to 90% decline in Profusa’s revenue projection numbers, or significant delays in the ramp up of Profusa’s growth assumptions (up to 6 quarters), or both. •Regarding Lumee Glucose, by the end of Q2 2025, Profusa management expects the establishment of distribution partnerships in both the United States and Europe with a large player that either has an existing Continuous Glucose Monitoring (CGM) product line, or otherwise is a mid (defined as market capitalization of greater than $2 billion and less than $10 billion at the time such a distribution deal is finalized) or large -cap(defined as a market capitalization of greater than $10 billion at the time such a distribution deal is finalized) medical device or digital health player with an interest in entering the space which will account for the rapid increase in annual revenue when compared to that of full year 2024. The negative impact on Profusa’s revenue would be significant (up to 90% decline of its forecasted revenue) should the partnership fail to be consummated. Management views the fact that Profusa has undertaken business development discussions (largely but not solely pertaining to commercialization of Lumee Oxygen in the United States) with more than 30 separate entities in the 5 years preceding this filing, the majority of whom are larger either in terms of annual revenue or market cap