Company: PFSA
Filing Date: 2025-10-29
Form Type: 424B3
Source: 0001213900-25-103174
Chunk: 217

Company: Profusa, Inc.
Filing Date: 2025-10-29
Form: 424B3
Chunk 217
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 study
plan or the rights, safety or welfare of human subjects.

During a study, the sponsor
is required to comply with the applicable FDA requirements, including, for example, trial monitoring, selecting clinical investigators
and providing them with the investigational plan, ensuring IRB review, adverse event reporting, record keeping and prohibitions on the
promotion of investigational devices or on making safety or effectiveness claims for them. The clinical investigators in the clinical
study are also subject to FDA regulations and must obtain patient informed consent, rigorously follow the investigational plan and study
protocol, control the disposition of the investigational device, and comply with all reporting and recordkeeping requirements. Additionally,
after a trial begins, we, the FDA or the IRB could suspend or terminate a clinical trial at any time for various reasons, including a
belief that the risks to study subjects outweigh the anticipated benefits.

Post-market Regulation

After a device is cleared or
approved for marketing, numerous and pervasive regulatory requirements continue to apply. These include:

| ● | establishment registration and device listing with the FDA; |

| ● | QSR requirements, which require manufacturers, including third-party manufacturers, to follow stringent                                    
 design, testing, control, documentation and other quality assurance procedures during all aspects of the design and manufacturing process; |

| ● | labeling regulations and FDA prohibitions against the promotion of investigational products, or the promotion 
 of “off-label” uses of cleared or approved products;                                                          |

| ● | requirements related to promotional activities; |

| ● | clearance or approval of product modifications to 510(k)-cleared devices that could significantly affect                              
 safety or effectiveness or that would constitute a major change in intended use of one of our cleared devices, or approval of certain 
 modifications to PMA-approved devices;                                                                                                |

| ● | medical device reporting regulations, which require that a manufacturer report to the FDA if a device                                   
 it markets may have caused or contributed to a death or serious injury, or has malfunctioned and the device or a similar device that it 
 markets would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur;                          |

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| ● | correction, removal and recall reporting regulations, which require that manufacturers report to the FDA                                
 field corrections and product recalls or removals if undertaken to reduce a risk to health posed by the device or to remedy a violation 
 of the FDCA that may present a risk to health;                                                                                          |

| ● | the