Company: PFSA
Filing Date: 2025-10-29
Form Type: 424B3
Source: 0001213900-25-103174
Chunk: 58

Company: Profusa, Inc.
Filing Date: 2025-10-29
Form: 424B3
Chunk 58
---
 and results of operations could decline.

If we or our suppliers or distributors fail to comply with ongoing regulatory requirements, or if we have unanticipated problems with our products, the products could be subject to restrictions or withdrawal from the market.

Our products, if cleared or
approved, would be subject to extensive regulation as medical devices in the United States and elsewhere, including by the FDA and
its foreign counterparts. Any product for which we obtain marketing approval, clearance or authorization (and the activities related to
its production, distribution, and promotion, sale, and marketing) will be subject to continual review and periodic inspections by the
FDA and other regulatory bodies, which may include inspection of our manufacturing processes, complaint handling and adverse event reporting,
post-approval clinical data and promotional activities for such product. The FDA’s Medical Device Reporting, or MDR, regulations
require that we report to the FDA any incident in which our product may have caused or contributed to a death or serious injury, or in
which our product malfunctioned and, if the malfunction were to recur, it would likely cause or contribute to a death or serious injury.

In addition, government regulations
specific to medical devices are wide ranging and govern, among other things:

| ● | product design, development, manufacture, and release; |

| ● | laboratory and clinical testing, labeling, packaging, storage and distribution; |

<div align='center'>31</div>

| ● | product safety and efficacy; |

| ● | premarketing clearance or approval; |

| ● | record keeping; |

| ● | product marketing, promotion and advertising, sales and distribution; |

| ● | post-marketing surveillance, including reporting of deaths or serious injuries and recalls and correction 
 and removals;                                                                                             |

| ● | post-market approval studies; and |

| ● | product import and export. |

If the FDA determines that
there is a reasonable probability that a device intended for human use would cause serious, adverse health consequences or death, the
agency may issue a cease distribution and notification order and a mandatory recall order. We may also decide to recall a product voluntarily
if we find a material deficiency, including unacceptable risks to health, manufacturing defects, design errors, component failures, labeling
defects, or other issues. Recalls of our products could divert the attention of our management and have an adverse effect on our reputation,
financial condition, and operating results.

We and certain of our suppliers
are also required to comply with the FDA’s Quality System Regulation, or QSR