Company: PFSA
Filing Date: 2025-05-15
Form Type: 424B3
Source: 0001213900-25-044417
Chunk: 300

Company: Profusa, Inc.
Filing Date: 2025-05-15
Form: 424B3
Chunk 300
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 cost of 1 device & 2 injectable sensors, annually. •A cost of the Lumee Oxygen initial device and Injectable sensor package of $400 and $50, respectively, and continued manufacturing optimization and supply chain efficiencies over the lifecycle of the product would decreased Lumee Oxygen cost to $150 and Injectable sensor package to $25 by Q4 of 2026; •A cost of the Lumee Glucose initial device and injectable sensor package of $163 and $25, respectively, at the expected product launch in Q4 2026, with Lumee Glucose cost of sales per patient decreasing over time due to manufacturing efficiencies learned from Lumee Oxygen and supply chain efficiencies. ____________ 2See Abbott press release dated February 20, 2020 stating in part “Abbott’s FreeStyle Libre system is now being used by more than 2 million people living with diabetes.” 18Internal modeling 150 •Sales and Marketing expense estimates are based on management’s experience, market research data, publicly available data from competitors, and other business and economic data. Estimated sales commission and rebates are the largest driver of the sales and marketing expense estimated to be approximately 12% and 1.5% of revenue, respectively. Additionally, management based the estimates for advertising, trade shows, and salaries on prior experience, publicly available data from competitors, and other financial and economic resources. •Research and development (R&D) expense estimates are driven by clinical trial costs, development of the Lumee Glucose Reader, and additional iterations on the Lumee platform. Expense estimates for clinical trials were based on estimated number of patients needed to successfully submit a package to the FDA. Per patient costs were based on both historical costs for similar studies we have incurred and quotes we have received for future studies. The number of subjects needed could be more, which would have a negative impact on the overall R&D expense estimates. Salary and development costs are based on historical salary expense, and future assumptions of headcount increases as the company grows. Product development costs are based on both quotes we have received from contract manufacturing partners and management’s assumptions on future product development expense. •Additional key assumptions included in the research and development estimates: •Estimated enrollment across the studies would equal 160 subjects. •R&D costs would be comprised of a mix of internal resources and utilization of a contract manufacturer to develop devices. •Profusa plans to invest in external contract manufacturing which is why there isn’t any significant CAPEX forecasted •General and Administrative (G&A