Company: PFSA
Filing Date: 2025-04-03
Form Type: S-4/A
Source: 0001213900-25-028544
Chunk: 289

Company: Profusa, Inc.
Filing Date: 2025-04-03
Form: S-4/A
Chunk 289
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and viability -checkedwith the patient launch numbers for existing competitor Abbott, manufacturers of the Freestyle Libre CGM system. Abbott was used as a reference point since it is a recent entrant to the market 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. Abbott was able to attain rapid market share due to, among other factors, its competitive lowest -in-the-marketEU and US pricing vs. Dexcom and Medtronic. As opposed to assuming Profusa’s relative pricing advantage to existing players upon launch will mimic Abbott’s advantage in 2017, Profusa assumed that low costs to healthcare systems remains a significant factor in product adoption, among other factors such as sensor duration and ease of sensor insertion, to name a few. Abbott’s numbers were therefore not directly incorporated into any analysis or modeling. Rather, Profusa used the trends of Abbott user number progression as a thesis to show how competition among existing players can affect projected potential sales momentum. Profusa recognizes Abbott is one of the largest medical device companies in the world (by market cap and revenue) with significant capacity for rapid market adoption and therefore investors should not assume Profusa will have the same resources at its disposal, even if Profusa goes to market in partnership with a major player. •Lumee Oxygen will see accelerated revenue in 2023 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.

142 •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