Company: PFSA
Filing Date: 2025-11-19
Form Type: 10-Q
Source: 0001213900-25-112723
Chunk: 258

Company: Profusa, Inc.
Filing Date: 2025-11-19
Form: 10-Q
Item: Part I, Item 2
Chunk 258
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Item 2.  Management’s Discussion
and Analysis of Financial Condition and Results of Operations.

This Report includes forward-looking statements within the meaning
of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange
Act”). We have based these forward-looking statements on our current expectations and projections about future events. These forward-looking
statements are subject to known and unknown risks, uncertainties and assumptions about us that may cause our actual results, levels of
activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements
expressed or implied by such forward-looking statements. In some cases, you can identify forward-looking statements by terminology such
as “may,” “should,” “could,” “would,” “expect,” “plan,” “anticipate,”
“believe,” “estimate,” “continue,” or the negative of such terms or other similar expressions. Factors
that might cause or contribute to such a discrepancy include, but are not limited to, those described in our other Securities and Exchange
Commission (“SEC”) filings.

Business Overview

We are a clinical-stage digital 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