Company: PFSA
Filing Date: 2025-10-29
Form Type: 424B3
Source: 0001213900-25-103174
Chunk: 202

Company: Profusa, Inc.
Filing Date: 2025-10-29
Form: 424B3
Chunk 202
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, no
serious adverse events (SAEs) or other related to Lumee Oxygen have been reported.

Continuous Glucose Monitoring product

Lumee Glucose is an investigative
product development system as Profusa has yet to receive the regulatory approval necessary for commercialization in any jurisdiction.
It is under development to monitor optical signals that represent glucose levels in the interstitial fluid of subcutaneous tissue continuously
and long-term. This glucose sensing system is composed of 1) a Glucose Sensing Hydrogel, 2) a Hydrogel delivery/injection pen, and 3)
a Hydrogel Reader and software. The software is designed to be used with a User Interface on a Tablet or Smartphone.

Lumee Glucose is designed and
developed by Profusa. The Profusa Glucose First-In-Human (FIH) Platform had been approved for investigational use by the Competent Authority
in Germany (BfArM) on May 4, 2018. Follow-up development studies with significantly improved Glucose Platform components, including
the sensing hydrogel and reader, received approval for investigational use in several jurisdictions: by the Competent Authority in Austria
(AGES) on May 8, 2020 and January 11, 2021; by the Competent Authority in Germany (BfArM) on

November 26, 2020; by
the Competent Authority in Vietnam (Ministry of Health) on September 10, 2020. Study conduct took place in all jurisdictions with
a total enrollment of 54 subjects. The active glucose monitoring phase for up to 12 months had been completed by the end of 2021.
The European studies are still open for extended safety monitoring per protocol for up to 3 years observation. The study in Vietnam
does allow amendments for additional device iterations, which will be implemented as soon as practical for the next phase of Profusa’s
clinical study program.

Profusa continues to have ongoing
communication with the Competent Authorities in Europe for the current studies periodically reporting on extended safety observations
for long-term sensor placement. Submission of new study protocols is expected early 2024, employing the first commercial generation platform
demonstrating safety and effectiveness (accuracy and intended use performance) aiming at regulatory clearance purposes, i.e. CE Mark.

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In parallel the technology
is going be presented to FDA to obtain Investigational Device Exemptions for study conduct in the U.S.