Company: PFSA
Filing Date: 2025-05-13
Form Type: S-4/A
Source: 0001213900-25-042224
Chunk: 301

Company: Profusa, Inc.
Filing Date: 2025-05-13
Form: S-4/A
Chunk 301
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 Vascular Devices Market Analysis US 2019 9Medtech 360 Report. Peripheral Vascular Devices Market Analysis US 2019

147 •Additional key assumptions regarding Lumee Oxygen include: •Revenue per subject in CLI would be equal to $600; •Product receives additional indication approval by the FDA for PAD in the US in 2027; •Product receives additional CE approval for PAD in Europe in 2028; •2030 average penetration rate of 1.86% across all indications and markets. Lumee Oxygen Revenue annual growth rates of: 2027 – 291%; 2028 – 127%; 2029 – 82%; 2030 – 60%.; •Regarding the Lumee Glucose product, Profusa’s assumptions include the size and growth of the market mentioned above, plus the inclusion of the type 2 market largely unserved by the CGM technology currently available. Profusa’s revenue assumptions are based on Profusa’s structural cost 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