Company: PFSA
Filing Date: 2025-10-29
Form Type: 424B3
Source: 0001213900-25-103174
Chunk: 211

Company: Profusa, Inc.
Filing Date: 2025-10-29
Form: 424B3
Chunk 211
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Lumee Glucose will compete with Dexcom, Abbott and Medtronic technologies. Profusa anticipates the launch of multiple noninvasive technologies
in the next years which may affect the competitive landscape, which may take the form of wristbands or smartwatches.

Government Regulation

United States Food and Drug Administration

In the United States,
our products are subject to regulation by the FDA as medical devices pursuant to the Federal Food Drug and Cosmetic Act (FDCA). The FDA
regulates the development, design, non-clinical and clinical research, manufacturing, safety, efficacy, labeling, packaging, storage,
installation, servicing, recordkeeping, premarket clearance or approval, adverse event reporting, advertising, promotion, marketing and
distribution, and import and export of medical devices to ensure that medical devices distributed domestically are safe and effective
for their intended uses and otherwise meet the requirements of the FDCA.

FDA Premarket Clearance and Approval Requirements

Unless an exemption applies,
each medical device commercially distributed in the United States requires either FDA clearance of a 510(k) premarket notification,
approval of a De Novo application, or approval of a premarket approval (PMA). Under the FDCA, medical devices are classified into one
of three classes — Class I, Class II or Class III — depending on the degree of risk associated
with each medical device and the extent of manufacturer and regulatory control needed to ensure its safety and effectiveness. Class I
includes devices with the lowest risk to the patient and are those for which safety and effectiveness can be assured by adherence to the
FDA’s General Controls for medical devices, which include compliance with the applicable portions of the Quality System Regulation
(QSR) facility registration and product listing, reporting of adverse medical events, and truthful and non-misleading labeling, advertising,
and promotional materials. Class II devices are subject to the FDA’s General Controls, and special controls as deemed necessary
by the FDA to ensure the safety and effectiveness of the device. These special controls can include performance standards, post-market
surveillance, patient registries and FDA guidance documents.

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While most Class I devices
are exempt from the 510(k) premarket notification requirement, manufacturers of most Class II devices are required to submit
to the FDA a premarket notification under Section 510(k) of the FDCA requesting permission to commercially distribute the device.
The FDA’s permission to commercially distribute a device subject to a 510(k) premarket notification is generally known as