Company: PFSA
Filing Date: 2025-05-15
Form Type: 424B3
Source: 0001213900-25-044417
Chunk: 298

Company: Profusa, Inc.
Filing Date: 2025-05-15
Form: 424B3
Chunk 298
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 accelerated revenue in 2027 on the basis of various factors, including but not limited to intensified collaboration with and product endorsement by physicians it considers Key Opinion Leaders (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. Regarding Lumee Glucose, by the end of Q2 2027, 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 -cap(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 assessment that growth rates are reasonable. Profusa feels the initial revenue during the launch year is reasonable based on the size of the market, the degree of competition, and its product’s competitive advantages in the space. Additionally, its assumption of distributor network in key markets during Profusa’s initial launch years, and number of clinical practices needed to achieve the patient volume for the initial years were also taken into account.

149 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 10 separate entities in the 5 years preceding this filing, the majority of whom are larger either in terms of annual revenue or market cap, as evidence that such a partnership is both reasonable and tenable, as Profusa’s ability to elicit interest from a large variety of companies has therefore been shown. While the Abbott Freestyle Libre CGM system was not used as a direct input for Profusa’s revenue forecast model