Company: PFSA
Filing Date: 2025-10-29
Form Type: 424B3
Source: 0001213900-25-103174
Chunk: 199

Company: Profusa, Inc.
Filing Date: 2025-10-29
Form: 424B3
Chunk 199
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 which resulted in approval of
an IDE application for performing studies in the U.S. as described below. Communications with FDA in 2019 did focus on design questions
for a pivotal study with the Wireless Lumee Oxygen Platform which would serve the needs of a subsequent De Novo submission. An IDE application
was approved in April 2019 and a supplement to accommodate Covid pandemic conditions was subsequently approved. Nevertheless, the
practical execution of the study had been significantly and negatively impacted by the pandemic due to the lack of access of non-essential
personnel in health care settings. Today the pilot phase of the study has been completed confirming the pivotal study phase design, and
the study will continue into the pivotal phase.

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Lumee Oxygen Clinical Study Overview

The Profusa Wireless Lumee
Oxygen Platform and its predecessor, the Lumee Oxygen Platform, are designed to measure changes of oxygen level in the tissue, continuously
and long-term. It is designed to report oxygen levels intra-operatively during an operation at a medical facility, and/or used as a monitoring
method pre- or post-operatively at a clinic. Up to four anatomical sites can be measured and reported concurrently. It is intended for
use in patients with potential acute and/or chronic changes in tissue oxygen levels who may benefit from monitoring.

The features of both the Profusa
Wireless Lumee Oxygen Platform and the Lumee Oxygen Platform are expected to provide added value to clinicians when compared with current
alternative technologies. Both Lumee systems provide a new method for measuring tissue oxygen concentration in the interstitial fluid
without perturbing the tissue after the initial injection. In addition, the Wireless Lumee Platform uses a small portable reader and tablet
to display tissue oxygen. This increased usability lends itself to use within many settings, such as ambulatory care settings.

The Lumee Oxygen Platform and
the Wireless Lumee Oxygen Platform do not estimate oxygen saturation in the vasculature, nor is it an averaged measurement across a large
volume of tissue, rather it provides a direct measure of oxygen availability in the interstitial fluid (referred to as tissue oxygen concentration).
The Lumee Oxygen sensor can be placed at a target depth of 3-6mm beneath the skin, enabling clinicians to monitor tissues of interest,
and it is not limited to measurement of superficial tissue layers. Furthermore, it can provide insight into the changes occurring in tissue
oxygen levels in both acute and chronic use cases. The Lumee Oxygen system