Company: PFSA
Filing Date: 2025-05-15
Form Type: 424B3
Source: 0001213900-25-044417
Chunk: 293

Company: Profusa, Inc.
Filing Date: 2025-05-15
Form: 424B3
Chunk 293
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 approval in the US by late 2026, with commercialization in EU based on the CE approval and successful MDR transition in EU by Q4 2025. It is estimated that the time from approval to commercial availability will be approximately one quarter for each product with associated revenue from distributor stocking orders. This assumption was based on discussions with contract manufacturing partners and Profusa’s management’s past experience. •Revenue forecasts were based on a compilation of market data from various sources for both PAD/CLI management in the case of the Lumee Oxygen product, and diabetes prevalence and market size for the Lumee Glucose product. The sources of market size and market growth information include: Academic publications, the American Diabetes Association, US and EU census bureaus as well as other relevant sources. 1,2,3Penetration rates for each addressable market were estimated by applying range of sizes of patient volume per clinical practice, assuming market coverage through distribution and commercial partners, and practicality of that coverage through our contemplated commercial network. In year one, we assumed our initial distribution network to be with 6 distributor partners covering 8 key tier -1countries in the EU, providing sales and support total coverage of 22 – 25 medical centers treating PAD/CLI patients. Each center was assumed to have adoption volume of approximately 8 patients utilizing Lumee Oxygen per week at a price of 800 Euros per case. We applied the penetration rates, which ranged from 0.02% in year one of commercialization to 3% by year 7 and beyond. In developing the penetration rates, other information was considered, including competition, product acceptance, product pricing, and timing of reimbursement. 4,5Additional consideration was also given to the number of accounts required for the conversion of user needed to achieve these penetration levels. 6 •Regarding the Lumee Oxygen product, as direct tissue perfusion measurement technologies are currently limited on the market, Profusa’s revenue assumption is more directly based on pricing and the likelihood of adoption by physicians and providers to absorb the costs within the current DRG codes for reimbursement. 7Through internal and market research it was determined that the price point of 600 Euros for Critical Limb Ischemia (CLI) patients and 300 Euros for Peripheral Arterial Disease (PAD) patients per year provide the proper incentive for adoption. 8Associated growth in penetration and revenue is assumed after reimbursement is achieved 3 -5years, depending on segments, post launch. 9 ____________ 1https://ec