Company: PFSA
Filing Date: 2025-05-15
Form Type: 424B3
Source: 0001213900-25-044417
Chunk: 295

Company: Profusa, Inc.
Filing Date: 2025-05-15
Form: 424B3
Chunk 295
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 advantage allowing us to provide a CGM solution in the type 2 market at a cost comparable to current fingerstick solutions. 10Profusa assumed that the number of patients they will be able to convert to Profusa’s technology in the type 2 market to be 80,000 patients in US and EU, with implied associated penetration rates of approximately 0.2% across both insulin using and non -insulinusing Type 2 patients in 2027, growing to 950,000 patients with implied associated market penetration rate of 2% by 2030. 11,12Consideration was given to competitive landscape today as well as timing of reimbursement and accounted for in Profusa’s penetration rate assumptions. 13As Profusa’s cost of goods are relatively favorable, Profusa assumed that pre -reimbursementadoption can be a reasonable path to early usage through a subscription model with monthly payments. 14,15 •Additional key assumptions regarding Lumee Glucose include: •Profusa completes clinical studies in Europe and achieves CE mark for Type 2 Diabetes in 2026. •The products average penetration rate for European Glucose sales in 2026 is 0.06%. •Revenue per subject for diabetes from the professional -useversion and the personal -useversion is equal to $350 and $900, respectively. •2030 average penetration rate of 0.86% across all indications and markets. Lumee Glucose Revenue annual growth rates of: 2027 – 5,873%; 2028 – 205%; 2029 – 77%; 2030 – 63%. 16 •Profusa’s forecasts and key performance indicators are based on a number of assumptions, internal and third -partyestimates in published literature, and other business data, including assumptions and estimates relating to Profusa’s ability to manage operating expenses of, invest in, develop and generate revenue from Profusa’s in vivo sensing platforms and related services in the future. 17While Profusa believes its assumptions and the data underlying Profusa’s estimates and key performance indicators are reasonable, there are inherent challenges in measuring or forecasting such information. As a result, these assumptions and estimates may not be correct and the conditions supporting Profusa’s assumptions or estimates may change at any time, thereby reducing the predictive accuracy of these underlying factors and metrics. Consequently, Profusa’s estimates of the total addressable markets and Profusa’s forecasts of market growth for Profusa’s novel in vivo sensing platform and differentiated product candidates may