Company: PFSA
Filing Date: 2025-08-21
Form Type: S-1/A
Source: 0001213900-25-079401
Chunk: 195

Company: Profusa, Inc.
Filing Date: 2025-08-21
Form: S-1/A
Chunk 195
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                        |     | 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.

126 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 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, 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 -siteQuality System audits to ensure they are compliant with cGMP requirements and any other