Company: PFSA
Filing Date: 2025-10-29
Form Type: 424B3
Source: 0001213900-25-103174
Chunk: 60

Company: Profusa, Inc.
Filing Date: 2025-10-29
Form: 424B3
Chunk 60
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 if regulatory approval
or clearance of a product is granted, the approval or clearance may be subject to limitations on the indicated uses for which the product
may be marketed or contain requirements for costly post-marketing testing or surveillance to monitor the safety or effectiveness of the
product. Later discovery of previously unknown problems with our products, including software bugs, unanticipated adverse events or adverse
events of unanticipated severity or frequency, manufacturing problems, or failure to comply with regulatory requirements such as the QSR,
MDR reporting, or other post-market requirements may result in restrictions on such products or manufacturing processes, withdrawal of
the products from the market, voluntary or mandatory recalls, fines, suspension of regulatory approvals, product seizures, injunctions,
the imposition of civil or criminal penalties, or criminal prosecution. In addition, our distributors have rights to create marketing
materials for their sales of our products, and may not adhere to contractual, legal or regulatory limitations that are imposed on their
marketing efforts.

We may be subject to fines, penalties and injunctions if we are determined to be promoting the use of our products for unapproved or improper off-label uses or determined to have made claims that are untruthful or misleading or not adequately substantiated.

We believe our marketing, promotional
and educational materials and practices comply with FDCA, Federal Trade Commission Act, and other applicable laws and regulations, as
may be amended from time to time. If the FDA, FTC or other regulatory body with competent jurisdiction over us, our activities or products
takes the position that our marketing, promotional or other materials or activities constitute improper promotion or marketing of an unapproved
or improper use, or that they contain untruthful, misleading, or inadequately substantiated statements or claims, such regulatory body
could request that we modify our materials or practices, or subject us to regulatory enforcement actions, including the issuance, depending
on the regulatory body and the nature of the alleged violation, of a warning letter, injunction, seizure, civil fine and criminal penalties.
It is also possible that other federal, state or foreign enforcement authorities might take action if they consider promotional, marketing
or other materials or activities to constitute improper promotion of an unapproved use, which could result in significant fines or penalties
under other statutory authorities, such as laws prohibiting false claims for reimbursement. Recent court decisions have impacted the FDA’s
enforcement activity regarding off-label promotion in light of First Amendment considerations; however, there are still significant risks
in this area in part due to the potential False Claims