Company: PFSA
Filing Date: 2025-10-29
Form Type: 424B3
Source: 0001213900-25-103174
Chunk: 24

Company: Profusa, Inc.
Filing Date: 2025-10-29
Form: 424B3
Chunk 24
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 the United States. In order to obtain marketing approval for our products in the
United States and in other jurisdictions, we will be required to conduct additional clinical trials. Clinical testing is
difficult to design and implement, can take many years, can be expensive and carries uncertain outcomes. The long-term effects
of using our products in a large number of patients have not been studied and the results of short-term clinical use of such
products do not necessarily predict long-term clinical benefits or reveal long-term adverse effects.

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The results of preclinical
studies and clinical trials of our products conducted to date and ongoing or future studies and trials of our current, planned or future
products may not be predictive of the results of later clinical trials, and interim results of a clinical trial do not necessarily predict
final results. Regulatory authorities may disagree with our interpretation of data and results from our clinical trials, and favorable
results do not ensure that we will achieve similar results in future clinical trials. Preclinical and clinical data are often susceptible
to various interpretations and analyses, and many companies that have believed their products performed satisfactorily in preclinical
studies and earlier clinical trials have nonetheless failed to replicate results in later clinical trials. Failure can occur at any stage
of clinical testing. Our clinical studies may produce negative or inconclusive results, and we may decide, or regulators may require us,
to conduct additional clinical and nonclinical testing in addition to those we have planned. In addition, it is possible that FDA will
impose, as a condition of marketing authorization for future products, requirements that we conduct post-market surveillance studies or
clinical studies as a condition of clearance or approval, which may reduce or delay our ability to obtain profitability with such products.

The initiation and completion
of any clinical studies may be prevented, delayed or halted for numerous reasons. We may experience delays in our ongoing clinical trials
for a number of reasons, which could adversely affect the costs, timing or successful completion of our clinical trials, including related
to the following:

| ● | we may be required to submit an investigational device exemption application, or IDE, to the FDA, which                               
 must become effective prior to commencing certain human clinical trials of medical devices, and the FDA may reject our IDE and notify 
 us that we may not begin clinical trials;                                                                                             |

| ● | regulators may disagree as to the design or implementation of our clinical trials; regulators and/or institutional                      
 review boards, or IRBs, or other