Company: PFSA
Filing Date: 2025-04-03
Form Type: S-4/A
Source: 0001213900-25-028544
Chunk: 302

Company: Profusa, Inc.
Filing Date: 2025-04-03
Form: S-4/A
Chunk 302
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 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.

148 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, the Lumee Glucose revenue numbers were cross -referencedand viability -checkedwith the patient launch numbers for existing competitor the Freestyle Libre CGM system. Abbott was used as a reference point since it is a recent entrant to the market as well as their platform use -case, and Abbott’s launch numbers are indicated in existing Wall Street sell -sideanalyst coverage. In the United States, Abbott showed more than 100,000 patients for end of year 2018, after personal -useCGM launch end of 2017. Abbott was used as a reference point and not as a target for the patient numbers Profusa expects to achieve. According to the JPMorgan DexCom analyst report from 2019, Abbott’s Freestyle Libre was launched at the end of 2014 and achieved usage numbers of 185,000 in 2016, 450,000 in