Company: PFSA
Filing Date: 2025-10-29
Form Type: 424B3
Source: 0001213900-25-103174
Chunk: 209

Company: Profusa, Inc.
Filing Date: 2025-10-29
Form: 424B3
Chunk 209
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 |     | Republic of Korea         |     | 6/29/2018           |
| Sensors and Chemistry |     | Republic of Korea         |     | 6/27/2019           |
| Sensors and Chemistry |     | US                        |     | 11/4/2019           |
| Sensors and Chemistry |     | US                        |     | 6/26/2023           |
| Sensors and Chemistry |     | US                        |     | 12/8/2020           |
| Sensors and Chemistry |     | US                        |     | 5/26/2020           |
| Sensors and Chemistry |     | US                        |     | 9/14/2020           |
| Sensors and Chemistry |     | US                        |     | 6/27/2019           |
| Misc                  |     | Canada                    |     | 4/21/2021           |
| Misc                  |     | Japan                     |     | 4/21/2021           |
| Misc                  |     | Patent Cooperation Treaty |     | 4/21/2021           |

Manufacturing and Quality Systems

Profusa manufactures class III
medical device implantable sensors within an ISO compliant manufacturing facility and quality system. All internal manufacturing activities
are conducted and managed per current Good Manufacturing Practices (cGMP), which are the recognized standards for the FDA and other global
regulatory agencies. Profusa manufacturing processes comply with all aspects of cGMP and has procedures in place for the following activities:
Supplier selection, evaluation and monitoring, Incoming receiving inspection requirements, Documented manufacturing procedures and work
instructions, Operator training program, and compliant manufacturing spaces including a certified, class 7, controlled environment
room (CER). Over 90% of the implantable sensor manufacturing process, including production, cleaning, sizing, testing and packaging is
conducted within a clean room, which is inspected and certified on a quarterly basis.

Additionally, all devices are
produced utilizing a validated production process with multiple inspection and testing points to ensure quality throughout the process.
The overall process, including embedded test methods, is re-validated as necessary to ensure continued compliance with cGMP over time.
All manufacturing steps, materials, equipment, personnel and tools utilized in the production process are documented in highly detailed
Device History Records (DHR) to provide a written production history. The DHR also documents demonstrated compliance to Manufacturing
Process Instructions (MPI) used and followed throughout the process.

Externally,