Company: PFSA
Filing Date: 2025-02-12
Form Type: S-4/A
Source: 0001213900-25-012354
Chunk: 291

Company: Profusa, Inc.
Filing Date: 2025-02-12
Form: S-4/A
Chunk 291
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 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. 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 2017, 774,625 in 2018 and 1,529,000 in 2019, and more than 2 million people in early 2020. 2 Profusa’s management considered additional companies including DexCom and Senseonics. These companies were excluded from Profusa’s comparative review due to: (1)The timing of their product launch. For example, in the case of Dexcom, their launch was during the time where CGM adoption, and physician/user education on the benefit of CGM, was at its infancy. Clinical data on the advantage of CGM usage was sparce at that time, and current market conditions to launch a new CGM product is significantly different than when Dexcom launched their platform; and (2)The product use case. Profusa