Company: PFSA
Filing Date: 2025-10-29
Form Type: 424B3
Source: 0001213900-25-103174
Chunk: 42

Company: Profusa, Inc.
Filing Date: 2025-10-29
Form: 424B3
Chunk 42
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 for a variety of reasons. They may fail to follow specific protocols and procedures, fail
to comply with applicable regulations, or be the subject of FDA or other regulatory authority audits or inspections that result in allegations
of non-compliance (for example, resulting in Form 483 Observations, Warning Letters, or other FDA enforcement actions). Our manufacturers
and suppliers may also experience or be impacted by equipment malfunction, environmental factors, and public health emergencies including
but not limited to the COVID-19 pandemic, any of which could delay or impede their ability to meet our demand.

Further, if our sole- or single-source
suppliers shift their manufacturing and assembly sites to other locations, depending on the circumstances and nature of the item supplied,
in addition to quality system activities such as verification and validation, there could be a need for FDA notifications or submissions,
and the new locations could be subject to regulatory inspections. If there are regulatory delays or impediments impacting our suppliers
or us for any reason, we may not be able to quickly establish additional or replacement suppliers, particularly for our single-source
components, in part because of the custom nature of various parts we design. Any interruption or delay in the supply of components or
materials, or our inability to obtain components or materials from alternate sources at acceptable prices in a timely manner, could impair
our ability to meet the demand of our customers and cause them to cancel orders or switch to competitive products. For supply risks related
to the COVID-19 pandemic see our Risk Factor entitled, “The outbreak of the SARS-Cov-2 virus and its variants and the COVID-19 disease that it causes, or similar public health crises, could have a material adverse impact on our business, financial condition and results of operations, including our manufacturing, commercial operations and sales.”

Our reliance on these outside
manufacturers and suppliers also subjects us to other risks that could harm our business, including:

| ● | we may experience a reduction or interruption in supply, and may not be able to obtain adequate supply 
 in a timely manner or on commercially reasonable terms from additional or replacement sources;         |

| ● | our products are technologically complex and it is difficult to develop alternative supply sources; |

| ● | we are not a major customer of many of our suppliers, and these suppliers may therefore give other customers’ 
 needs higher priority than ours;                                                                              |

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| ● | our suppliers may make errors in manufacturing components that could negatively affect the quality, effectiveness 
 or