Company: PFSA
Filing Date: 2025-04-03
Form Type: S-4/A
Source: 0001213900-25-028544
Chunk: 292

Company: Profusa, Inc.
Filing Date: 2025-04-03
Form: S-4/A
Chunk 292
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 of this filing. •Except for Wireless Lumee Oxygen Platform, Profusa’s latest iteration of Lumee Oxygen, which has attained the European CE mark (however will still require the migration to conform to new MDR requirements in Europe) but for which Profusa has not dedicated substantial resources for commercialization and marketing, its products are all in the premarketing and clinical stages of development and, as such, Profusa recognizes that these programs may or may not ultimately result in revenues in either the United States or European Union or any other geography Profusa management may seek to consider targeting. •The projections assume further that Profusa will be able to harvest the benefits of increased Remote Patient Monitoring reimbursement not just in the United States, but also in individual European Union member states, 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