Company: PFSA
Filing Date: 2025-05-09
Form Type: S-4/A
Source: 0001213900-25-041151
Chunk: 303

Company: Profusa, Inc.
Filing Date: 2025-05-09
Form: S-4/A
Chunk 303
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 in 2030. Penetration rates for Lumee Glucose across all market segments in the US ranged from an average of .0001% in 2026 to an average .87% in 2030. The penetration rates estimated for Lumee Oxygen in the European market for PAD and CLI averaged .23% in 2026 to an average 1.73% in 2030. The average penetration rates in the US for both the PAD and CLI markets averaged .25% in 2026 rising to an average of 2% by 2030. The estimated total revenue was then calculated by multiplying the total addressable market by the estimated annual penetration rate in each market segment to derive total customers. Total customers multiplied by the applicable average unit sale price for Lumee Oxygen or Lumee Glucose then provided total revenue. Lumee Oxygen is projected to see 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