Company: PFSA
Filing Date: 2025-10-29
Form Type: 424B3
Source: 0001213900-25-103174
Chunk: 56

Company: Profusa, Inc.
Filing Date: 2025-10-29
Form: 424B3
Chunk 56
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functions that we are required to report to the FDA, and if we fail to do so, we would be subject to sanctions that could harm our reputation, business, financial condition and results of operations. The discovery of serious safety issues with our products, or a recall of our products either voluntarily or at the direction of the FDA or another governmental authority, could have a negative impact on us.

If our products are approved
or cleared, we will be subject to the FDA’s medical device reporting regulations and similar foreign regulations, which require
us to report to the FDA when we receive or become aware of information that reasonably suggests that one or more of our products may have
caused or contributed to a death or serious injury or malfunctioned in a way that, if the malfunction were to recur, could cause or contribute
to a death or serious injury. The timing of our obligation to report is triggered by the date we become aware of the adverse event as
well as the nature of the event. We may fail to report adverse events of which we become aware within the prescribed timeframe. We may
also fail to recognize that we have become aware of a reportable adverse event, especially if it is not reported to us as an adverse event
or if it is an adverse event that is unexpected or removed in time from the use of the product. Manufacturers are also expected to maintain
certain policies, procedures, and records regarding complaints and medical device reporting. If we fail to comply with our reporting and
recordkeeping obligations, the FDA could take action, including warning letters, untitled letters, it has come to our attention letters,
administrative actions, criminal prosecution, imposition of civil monetary penalties, revocation of our device clearance or approval,
seizure of our products or delay in clearance or approval of future products.

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The FDA and foreign regulatory
bodies have the authority to require the recall of commercialized products in the event of material deficiencies or defects in design
or manufacture of a product or in the event that a product poses an unacceptable risk to health. The FDA’s authority to require
a recall must be based on a finding that there is reasonable probability that the device could cause serious injury or death. We may also
choose to voluntarily recall a product if any material deficiency is found. A government-mandated or voluntary recall by us could occur
as a result of an unacceptable risk to health, component failures, malfunctions, manufacturing defects, labeling or design deficiencies,
packaging defects or