Company: PFSA
Filing Date: 2025-02-12
Form Type: S-4/A
Source: 0001213900-25-012354
Chunk: 286

Company: Profusa, Inc.
Filing Date: 2025-02-12
Form: S-4/A
Chunk 286
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 — only population 18 and over was considered 2https://www.cdc.gov/diabetes/basics/prediabetes.html#:~:text=What%20Is%20Prediabetes%3F,t%20know%20they%20have%20it. 3https://diabetesatlas.org/data/en/region/3/eur.html

139 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 •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