Company: PFSA
Filing Date: 2025-10-29
Form Type: 424B3
Source: 0001213900-25-103174
Chunk: 78

Company: Profusa, Inc.
Filing Date: 2025-10-29
Form: 424B3
Chunk 78
---
other agencies may also increase the time necessary for new products to be reviewed and/or approved by necessary government agencies,
which would adversely affect our business. For example, over the last several years, the U.S. government has shut down several
times, and certain regulatory agencies, such as the FDA and the SEC, have had to furlough critical employees and stop critical activities.
Separately, in response to the COVID-19 pandemic, in March 2020, the FDA temporarily postponed routine surveillance inspections of
domestic manufacturing facilities and provided guidance regarding the conduct of clinical trials, which has since been further updated
and is being refreshed on a periodic basis. The FDA has also noted that it is continuing to ensure timely reviews of applications for
medical products during the COVID-19 pandemic in line with its user fee performance goals and conducting “mission-critical”
domestic and foreign inspections to ensure compliance of manufacturing facilities with FDA quality standards.

Subsequently, in July 2020,
the FDA announced its intention to resume certain on-site inspections of domestic manufacturing facilities subject to a risk-based prioritization
system. The FDA intends to use this risk-based assessment system to identify the categories of regulatory activity that can occur within
a given geographic area, ranging from mission-critical inspections to resumption of all regulatory activities. The agency’s rating
system is used to assist in determining when and where it is safest to conduct such inspections based on data about the virus’s
trajectory in a given state and locality and the rules and guidelines that are put in place by state and local governments. The FDA’s
assessment of whether an inspection is mission-critical considers many factors related to the public health benefit of U.S. patients
having access to the product subject to inspection, including whether the products are used to diagnose, treat, or prevent a serious disease
or medical condition for which there is no other appropriate substitute. Both for-cause and pre-approval inspections can be deemed mission-critical.
The COVID-19 public health emergency determinations and declarations ended May 11, 2023. This is nonetheless subject to change.

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Risks Related to Intellectual Property Protection and Use

We may become subject to claims of infringement or misappropriation of the intellectual property rights of others, which could prohibit us from shipping affected products, require us to obtain licenses from third parties or to develop non-infringing alternatives, and subject us to substantial monetary damages and injunctive relief. We may also be subject to other claims