Company: PFSA
Filing Date: 2025-10-29
Form Type: 424B3
Source: 0001213900-25-103174
Chunk: 210

Company: Profusa, Inc.
Filing Date: 2025-10-29
Form: 424B3
Chunk 210
---
 Profusa only selects,
utilizes, and monitors qualified vendors for services or products related to manufacturing processes, which include Contract Manufacturers,
and Testing and Sterilization services. Prior to selection, Profusa Quality Assurance conducts on-site Quality System audits to ensure
they are compliant with cGMP requirements and any other required regulatory requirements. Additionally, all external produced products
or services conducted for Profusa manufactured products undergo testing at nationally accredited and certified testing facilities and
must meet Incoming Inspection criteria which Profusa had previously established prior to acceptance and utilization.

<div align='center'>123</div>

Competition

The competitive landscape regarding
both the Lumee Oxygen and Lumee Glucose sensing systems, if approved, is multi-faceted, with many companies with device offerings that
provide biochemical data in real time, as further described below.

Lumee Oxygen is designed to
be used complementarily with angiographic (radiographic visualization of blood vessels after injection of a radiopaque substance) and
computer tomographic (imaging of parts of the body with any kind of penetrating waves) technologies, or alone. We anticipate the creation
of a guidance algorithm to be used by a physician or other vascular specialist to incorporate both Lumee Oxygen values and angiographic
or computer tomographic readings.

Examples of such technologies
include digital subtraction angiography devices developed by Philips or Computed Tomography (CT) for peripheral use developed by Siemens
Healthineers.

Lumee Oxygen will also compete
with devices that use transcutaneous oximetry (TCPO2) to measure peripheral perfusion, such as those developed by Perimed AB, Radiometer
Medical or SenTec AG, to name examples.

Furthermore, doppler or cuff
devices measuring Ankle-Brachial Index (ABI), Toe-Brachial Index (TBI) or Segmental Pressure Values (SPP), as well as those enabling Pulse
Volume Recording (PVR) are anticipated to be competitive with Lumee Oxygen. Other experimental approaches include Near-Infrared Spectroscopy
(NIRS) for peripheral purposes.

In the personal use case, Lumee
Glucose will compete with existing Continuous Glucose Monitoring technologies, including those manufactured by Dexcom, Abbott, Medtronic,
Senseonics, Diamontech, Movano and Nemaura Medical. Each of these companies currently market Continuous Glucose Monitoring products that
target both Type 1 and Type 2 diabetes patients, as well as pre-diabetics.

In the professional use case