Company: PFSA
Filing Date: 2025-10-29
Form Type: 424B3
Source: 0001213900-25-103174
Chunk: 26

Company: Profusa, Inc.
Filing Date: 2025-10-29
Form: 424B3
Chunk 26
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 or we may experience interruptions 
 in supply;                                                                                                                                      |

| ● | approval policies or regulations of FDA or applicable foreign regulatory agencies may change in a manner 
 rendering our clinical data insufficient for approval;                                                   |

| ● | our current or future products may have undesirable side effects or other unexpected characteristics; 
 and                                                                                                   |

| ● | impacts of regional or global public health crises including the recent COVID-19 pandemic could adversely                                 
 affect any clinical trials we are conducting or plan to conduct, including by causing delays or difficulties in enrolling or onboarding   
 patients, initiating clinical sites, or obtaining the requisite regulatory approvals, interruption of key clinical trial activities, or   
 supply chain disruptions that delay or make it more difficult or costly to obtain the supplies and materials we need for clinical trials. |

Any of these occurrences may
significantly harm our business, financial condition and prospects. In addition, many of the factors that cause, or lead to, a delay in
the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval of our product candidates.

Patient enrollment in clinical
trials and completion of patient follow up depend on many factors, including the size of the patient population, the nature of the trial
protocol, the proximity of patients to clinical sites, the eligibility criteria for the clinical trial, patient compliance, competing
clinical trials and clinicians’ and patients’ perceptions as to the potential advantages of the product being studied in relation
to other available therapies, including any new treatments that may be approved for the indications we are investigating. For example,
patients may be discouraged from enrolling in our clinical trials if the trial protocol requires them to undergo extensive post treatment
procedures or follow up to assess the safety and efficacy of a product candidate, or they may be persuaded to participate in contemporaneous
clinical trials of a competitor’s product candidate. In addition, patients participating in our clinical trials may drop out before
completion of the trial or experience adverse medical events unrelated to our products. Delays in patient enrollment or failure of patients
to continue to participate in a clinical trial may delay commencement or completion of the clinical trial, cause an increase in the costs
of the clinical trial and delays, or result in the failure of the clinical trial.

Clinical trials must be conducted
in accordance with the laws and regulations of the FDA and other applicable regulatory authorities’ legal requirements, regulations
or guidelines, and are subject to oversight by these governmental agencies and IRBs at the medical institutions where the clinical trials
are conducted. In addition,