Company: PFSA
Filing Date: 2025-05-15
Form Type: 424B3
Source: 0001213900-25-044417
Chunk: 460

Company: Profusa, Inc.
Filing Date: 2025-05-15
Form: 424B3
Chunk 460
---
 or we) management believes is relevant to an assessment and understanding of Profusa’s results of operations and financial condition. The discussion should be read together with “Selected Historical Financial and Operating Data of Profusa,” the historical audited annual statements for the years ended December 31, 2024 and 2023, and the related notes that are included elsewhere in this proxy statement / prospectus. The discussion and analysis should also be read together with the pro forma financial information as of and for the years ended December 31, 2024 and 2023. See “Unaudited Pro Forma Condensed Combined Financial Information.” This discussion may contain forward -looking statements based upon current expectations that involve risks and uncertainties. Profusa’s actual results may differ materially from those anticipated in these forward -looking statements as a result of various factors, including those set forth under “Risk Factors” or in other parts of this proxy statement / prospectus. Unless the context otherwise requires, references in this section to “Profusa,” the “Company,” “we,” “us,” and “our,” refer to New Profusa, Inc. and its subsidiaries following the Business Combination (as defined below). Business Overview We are a clinical -stagedigital health and medical technology company focused on developing biosensing solutions to improve health outcome for patients in a variety of different diseases and conditions. Our first product is Lumee Oxygen, which enables physicians to ascertain the extent of perfusion, or passage of blood through the circulatory system to an organ or tissue, in patients with Critical Limb Ischemia (CLI) both during and after endovascular revascularization procedures. Lumee Oxygen has already received regulatory approval in Europe through the attainment of a CE mark; however, prior to commercialization in the U.S., Lumee Oxygen must obtain FDA clearance or approval. The latest version of Lumee Oxygen is called Wireless Lumee Oxygen System. It has multiple components one of which is a microsensor that is injected into the tissue of the patient using a hypodermic needle. The sensor is designed so it does not need to be removed as it overcomes the foreign body response that usually inhibits the ability of permanent implants to function. The sensor contains no electronics, utilizing luminescence to send a light signal to a reader that is placed over the incision site, which in turn can send a signal to an app on a smartphone. We are in clinical trials for Lumee Glucose, our sensing solution being developed for use in continuous glucose monitoring (CG