Company: PFSA
Filing Date: 2025-05-09
Form Type: S-4/A
Source: 0001213900-25-041151
Chunk: 451

Company: Profusa, Inc.
Filing Date: 2025-05-09
Form: S-4/A
Chunk 451
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 6/27/2019           |
| Sensors and Chemistry |     | Japan                     |     | 6/27/2019           |
| Sensors and Chemistry |     | Republic of Korea         |     | 12/27/2017          |
| Sensors and Chemistry |     | 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, class7, 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 -validatedas necessary to ensure continued compliance with cGMP over time. All manufacturing steps, materials, equipment, personnel and tools utilized in the production process