Company: PFSA
Filing Date: 2025-10-29
Form Type: 424B3
Source: 0001213900-25-103174
Chunk: 67

Company: Profusa, Inc.
Filing Date: 2025-10-29
Form: 424B3
Chunk 67
---
, which prohibits U.S. companies and their intermediaries from making payments
in violation of law to non-U.S. government officials for the purpose of obtaining or retaining business or securing any other improper
advantage. In many countries, the healthcare professionals that medical device distributors regularly interact with may meet the definition
of a foreign official for purposes of the FCPA. International business operations are also subject to various other international
anti-bribery laws such as the U.K. Anti-Bribery Act. Despite meaningful measures that we undertake to facilitate lawful conduct,
which include training and compliance programs and internal policies and procedures, we may not always prevent unauthorized, reckless
or criminal acts by our employees or agents, or employees or agents of businesses or operations we may acquire. Violations of these laws,
or allegations of such violations, could disrupt operations, involve significant management distraction and have a material adverse effect
on our business, financial condition and results of operations, among other adverse consequences.

Changes to the regulatory landscape may impact our ability to obtain marketing authorization for future product developments.

Development or changes to the
FDA or foreign regulatory approval standards and processes, including both legal and policy changes, could also delay or prevent the approval
of our products submitted for review. For example, as part of the 21 Century Cures Act passed in 2016, Congress enacted several
reforms that further affect medical device regulation both pre- and post-approval, and FDA implementation and development of guidance
in many areas is still ongoing. In addition, the FDA is in the process of reviewing the 510(k) approval process and criteria and
has announced initiatives to improve the current pre- and post-market regulatory processes and requirements associated with infusion pumps
and other home-use medical devices. As part of this effort, the FDA is reviewing the adverse event reporting and recall processes for
insulin pumps. Any change in the laws or regulations that govern the clearance and approval processes relating to our current 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. The data contained in our submissions, including data drawn from our clinical trials, may not be sufficient to support
clearance or approval of our products or additional or expanded indications.

<div align='center'>36</div>

Medical device company stock
prices have declined significantly in certain circumstances where companies have failed to meet expectations in regard to the timing of
regulatory approval. If the FDA’s response causes product approval delays