Company: PFSA
Filing Date: 2025-05-15
Form Type: 424B3
Source: 0001213900-25-044417
Chunk: 289

Company: Profusa, Inc.
Filing Date: 2025-05-15
Form: 424B3
Chunk 289
---
 which will see the targeting of pharmacy private payor benefits and utilization of existing CPT codes, and creation of new category III or I CPT codes, wherever applicable for both Medicare/Medicaid and private payor use. 144 •Penetration estimates were built by for both Lumee Oxygen and Lumee Glucose given the effectiveness and safety profiles of current existing products in the market along with other factors, such as, but not limited to, the hypothetical launch of entirely new types of products by competitors, favorable changes, both past and anticipated, in the reimbursement (for example expansion regarding Remote Patient Monitoring reimbursement in the United States) landscape. Projected revenue does not include the hypothetical launch of products that measure other analytes for which Profusa has prototypes, nor does it include hypothetical sales of Lumee Oxygen and Lumee Glucose in patient segments or for purposes not anticipated as described in other parts 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