Company: PFSA
Filing Date: 2025-10-29
Form Type: 424B3
Source: 0001213900-25-103174
Chunk: 68

Company: Profusa, Inc.
Filing Date: 2025-10-29
Form: 424B3
Chunk 68
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, or is not favorable for any of our products, our stock
price (and the market price of our senior convertible notes) could decline substantially. It is uncertain how these potential changes
may impact our ability to gain clearance or approval from FDA for our products in the future.

From time to time, legislation
is drafted and introduced in Congress that could significantly change the statutory provisions governing the regulatory approval, manufacture
and marketing of regulated products or the reimbursement thereof. In addition, the FDA may change its clearance and approval policies,
adopt additional regulations or revise existing regulations, or take other actions, which may prevent or delay approval or clearance of
our future products under development or impact our ability to modify our currently cleared products on a timely basis. Any new regulations
or revisions or reinterpretations of existing regulations may impose additional costs or lengthen review times of planned or future products.
It is impossible to predict whether legislative changes will be enacted or FDA regulations, guidance or interpretations changed, and what
the impact of such changes, if any, may be.

FDA regulations and guidance
are often revised or reinterpreted by the FDA in ways that may significantly affect our business and our products. Any new statutes, regulations
or revisions or reinterpretations of existing regulations may impose additional costs or lengthen review times of any future products
or make it more difficult to obtain clearance or approval for, manufacture, market or distribute our products. We cannot determine what
effect changes in regulations, statutes, legal interpretation or policies, when and if promulgated, enacted or adopted may have on our
business in the future. Such changes could, among other things, require: additional testing prior to obtaining clearance or approval;
changes to manufacturing methods; recall, replacement or discontinuance of our products; or additional record keeping.

The FDA’s and other regulatory
authorities’ policies may change and additional government regulations may be promulgated that could prevent, limit or delay regulatory
clearance or approval of our product candidates. We cannot predict the likelihood, nature or extent of government regulation that may
arise from future legislation or administrative action, either in the United States or abroad.

Any change in the laws or regulations
that govern the clearance and approval processes relating to our current, planned and future products could make it more difficult and
costly to obtain clearance or approval for new products or to produce, market and distribute existing products. Significant delays in
receiving clearance or approval or the failure to receive clearance or approval for any new products would have an adverse effect on