Company: PFSA
Filing Date: 2025-10-29
Form Type: 424B3
Source: 0001213900-25-103174
Chunk: 63

Company: Profusa, Inc.
Filing Date: 2025-10-29
Form: 424B3
Chunk 63
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. We may initiate voluntary recalls involving our products in the future that we determine
do not require notification to the FDA. If the FDA disagrees with our determinations, the FDA could require us to report those actions
as recalls. A future recall, withdrawal, or seizure of any product could materially and adversely affect consumer confidence in the Profusa
brand, lead to decreased demand for our products and negatively affect our sales. In addition, the FDA could take enforcement action for
failing to report recalls when they were conducted by us or one of our agents.

Health care policy changes, including U.S. health care reform legislation, may have a material adverse effect on our business.

Although we do not currently
have a product on the market in the U.S. and do not make patient referrals or bill Medicare, Medicaid, or other government or commercial
third-party payors, we may be subject to a number of healthcare statutory and regulatory requirements, and therefore may be affected by
changes in health care laws and regulations. In response to increases in health care costs in recent years, there have been and continue
to be proposals by the federal government, state governments, regulators, and third-party payors to control these costs and, more generally,
to reform the U.S. health care system. Certain of these proposals could limit the prices we are able to charge for the products we
may commercialize or the amounts of reimbursement available for the products we may commercialize and could limit the acceptance and availability
of our products. Further, while the United States has begun shifting to pay-for-performance rather than fee-for-service models and
has been embracing many shared-risk arrangements, the Centers for Medicare & Medicaid Services (CMS) and the Department of Health
and Human Services, Office of Inspector General (OIG) specifically excluded medical device manufacturers from utilizing the new, more
flexible Stark Law exceptions and Anti-Kickback Statute safe harbors under the Final Rules, part of the U.S. Department of Health
and Human Services’ Regulatory Sprint to Coordinated Care, which were published on December 2, 2020 in the Federal Register
and were largely effective January 19, 2021. The exclusion of manufacturers from utilizing these exceptions and safe harbors may
not allow us to avail ourselves of immunity from liability under the laws, potentially inviting greater scrutiny over any potential shared
risk arrangements.

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On November 16, 2020 the
OIG published a Special Fraud Alert addressing manufacturer