Company: PFSA
Filing Date: 2025-10-29
Form Type: 424B3
Source: 0001213900-25-103174
Chunk: 59

Company: Profusa, Inc.
Filing Date: 2025-10-29
Form: 424B3
Chunk 59
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, and other regulations which cover the methods and
documentation of the design, testing, production, control, selection and oversight of suppliers or contractors, quality assurance, labeling,
packaging, storage, complaint handling, shipping and servicing of our products. The FDA may enforce the QSR through announced (through
prior notification) or unannounced inspections.

Compliance with ongoing regulatory
requirements can be complex, expensive and time-consuming. Failure by us or one of our suppliers or distributors to comply with statutes
and regulations administered by the FDA, competent authorities and other regulatory bodies, or failure to take adequate response to any
observations, could result in, among other things, any of the following actions:

| ● | warning letters or untitled letters that require corrective action; |

| ● | delays in approving, or refusal to approve, our systems; |

| ● | fines and civil or criminal penalties; |

| ● | unanticipated expenditures; |

| ● | FDA refusal to issue certificates to foreign governments needed to export our products for sale in other 
 countries;                                                                                               |

| ● | suspension or withdrawal of clearance or approval by the FDA or other regulatory bodies; |

| ● | product recall or seizure; |

| ● | administrative detention; |

| ● | interruption of production, partial suspension, or complete shutdown of production; |

| ● | interruption of the supply of components from our key component suppliers; |

| ● | operating restrictions; |

| ● | court consent decrees; |

| ● | FDA orders to repair, replace, or refund the cost of devices; |

| ● | injunctions; and |

| ● | criminal prosecution. |

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The potential effect of these
events can in some cases be difficult to quantify. If any of these actions were to occur, it would harm our reputation and cause our product
sales and profitability to suffer. In addition, we believe events that could be classified as reportable events pursuant to MDR regulations
are generally underreported by physicians and users, and any underlying problems could be of a larger magnitude than suggested by the
number or types of MDRs filed by us. Furthermore, while we select and monitor our key component suppliers to ensure key quality objectives
are met and maintained, and performance of each key component supplier is continually re-evaluated based on objective evidence gathered
by our quality assurance department, we cannot be certain that our key component suppliers currently are or will always continue to be
in compliance with all applicable regulatory requirements.

Even