Company: PFSA
Filing Date: 2025-07-18
Form Type: 8-K
Source: 0001213900-25-065686
Chunk: 33

Company: Profusa, Inc.
Filing Date: 2025-07-18
Form: 8-K
Chunk 33
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 proceedings; and |

| ● | other factors, including those set forth in the section of the Proxy Statement entitled “Risk Factors” 
 beginning on page 27.                                                                                  |

Business

The information set forth
in the section of the Proxy Statement entitled “Profusa’s Business” beginning on page 233 is incorporated herein by
reference.

Risk Factors

The information
set forth in the section of the Proxy Statement entitled “Risk Factors” beginning on page 27 is incorporated herein by reference.

Selected Consolidated Historical Financial and Other Information

The information set
forth in the section of the Proxy Statement entitled “Selected Historical Financial and Operating Data of Profusa” beginning
on page 22 is incorporated herein by reference.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

The following discussion
and analysis of the Company’s financial condition and results of operations should be read in conjunction with the unaudited condensed
consolidated financial statements and the notes thereto contained elsewhere in this Report. Certain information contained in the discussion
and analysis set forth below includes forward-looking statements that involve risks and uncertainties.

Business Overview

We are a clinical-stage digital
health and medical technology company focused on developing biosensing solutions to improve health outcomes 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 (CGM). This system targets