Company: PFSA
Filing Date: 2025-05-09
Form Type: S-4/A
Source: 0001213900-25-041151
Chunk: 295

Company: Profusa, Inc.
Filing Date: 2025-05-09
Form: S-4/A
Chunk 295
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 even where to date, such as reimbursement is not available, in whole or in part. •The projections assume that Profusa will have, prior to market launch, the resources and staffing to present at large scientific conferences, such as but not limited to the Leipzig Interventional Conference held annually in Leipzig, Germany. •Projected EBITDA values remain negative for 2023: despite a decrease in CAPEX. However, Profusa management anticipates facing significant requirements for spending related to operating expenses, specifically as it regards Research and Development spending for clinical trials in the United States with the goal of eventual FDA marketing authorization for Lumee Glucose. Furthermore, Profusa management expects the doubling of Sales and Marketing -relatedoperating expenses in 2025. In 2025, new agreements related but not limited to reimbursement and insurance of Lumee Glucose by pharmacies, payors or other stakeholders, are expected to cost in terms of traveling expenses for marketing personnel, the commission of marketing related instruments such as pharmacoeconomic white papers or studies, and advertising. •Capital expenditures will decrease heavily in 2024 after Profusa prioritizes operating expenses such clinical trials and initial sales and marketing. Any required overhaul of production machinery of instruments, as well as lab space may take place in 2023, so as not to conflict with intensified clinical activity in the United States 2024. The bulk of such overhaul will already have taken place in 2022 with new large -scaleproduction equipment already having been purchased then, and in previous years. A second overhaul with potential acquisition of a new European production or business site will take place in 2025, commensurate with the launch of Lumee Glucose. Generally, the nature of the production process of components of Profusa products does not require capital expenses of a consistent or comparable level on an annualized basis. A further factor affecting EBITDA (due to increased CAPEX) has to do with Profusa ongoing need to enter contract manufacturing with vendors for the production of certain components of both Lumee Oxygen and Lumee Glucose. The projections assume certain costs as part of these agreements, which may materially shift for multiple reasons including but not limited to the competitive landscape of the vendor’s business, the cost of raw materials for the vendor, legal changes in contract manufacturing practices worldwide or also changes in regulatory requirements for the finished product. The projections reflect the assumption that a significant increase in net cash flow will occur in 2028, as there is a major turning point in revenue, with a significant