Company: PFSA
Filing Date: 2025-10-29
Form Type: 424B3
Source: 0001213900-25-103174
Chunk: 61

Company: Profusa, Inc.
Filing Date: 2025-10-29
Form: 424B3
Chunk 61
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 Act exposure and the FDA’s continued focus on ensuring devices are marketed
in a manner consistent with their FDA-required labeling.

It is also possible that other
federal, state or foreign enforcement authorities might take action if they consider our educational and promotional activities or training
methods to constitute promotion of an off-label use, which could result in significant fines or penalties under other statutory authorities,
such as laws prohibiting false claims for reimbursement. In that event, our reputation could be damaged, and adoption of the products
could be impaired. Although our policy is to refrain from statements that could be considered off-label promotion of our products, if
cleared or approved, the FDA or another regulatory agency could disagree and conclude that we have engaged in off-label promotion. It
is also possible that other federal, state or foreign enforcement authorities might take action, including, but not limited to, through
a whistleblower action under the FCA, if they consider our business activities to constitute promotion of an off-label use, which could
result in significant penalties, including, but not limited to, criminal, civil or administrative penalties, treble damages, fines, disgorgement,
exclusion from participation in government healthcare programs, reporting requirements and compliance oversight if we become subject to
a corporate integrity agreement or similar agreement to resolve allegations of non-compliance with these laws, and the curtailment or
restructuring of our operations. In addition, the off-label use of any products for which we receive approval or clearance may increase
the risk of product liability claims. Product liability claims are expensive to defend and could divert our management’s attention,
result in substantial damage awards against us, and harm our reputation.

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Our current or future products may be subject to product recalls even after receiving FDA clearance or approval. A recall of our products, either voluntarily or at the direction of the FDA, or the discovery of serious safety issues with our products, could have a significant adverse impact on us.

Medical devices can experience
performance problems in the field that require review and possible corrective action. The occurrence of component failures, manufacturing
errors, software errors, design defects or labeling inadequacies affecting a medical device could lead to a government-mandated or voluntary
recall by the device manufacturer, in particular when such deficiencies may endanger health. The FDA and similar governmental bodies in
other countries have the authority to require the recall of our products if we or our third-party manufacturers fail to comply with relevant
regulations pertaining to, among other things,