Company: PFSA
Filing Date: 2025-10-09
Form Type: S-1
Source: 0001213900-25-097860
Chunk: 24

Company: Profusa, Inc.
Filing Date: 2025-10-09
Form: S-1
Chunk 24
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 may be insufficient or slower than we anticipate, and the number of clinical trials being conducted at any given time 
 may be high and result in fewer available subjects for any given clinical trial, or subjects may drop out of these clinical trials at 
 a higher rate than we anticipate;                                                                                                     |

| ● | our third-party contractors, including those manufacturing products or conducting clinical trials or preclinical                       
 studies on our behalf, may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, 
 or at all;                                                                                                                             |

| ● | we might have to suspend or terminate clinical trials for various reasons, including a finding that the 
 subjects are being exposed to unacceptable health risks;                                                |

| ● | we may have to amend clinical trial protocols or conduct additional studies to reflect changes in regulatory             
 requirements or guidance, which we may be required to submit to an IRB and/or regulatory authorities for re-examination; |

| ● | regulators, IRBs or other parties may require or recommend that we or our investigators suspend or terminate   
 clinical research for various reasons, including safety signals or noncompliance with regulatory requirements; |

| ● | the cost of clinical trials may be greater than we anticipate; |

| ● | clinical sites may not adhere to the clinical protocol or may drop out of a clinical trial; |

12

| ● | we may be unable to recruit a sufficient number of clinical trial sites or study participants; |

| ● | regulators, IRBs or other reviewing bodies may find fault with our manufacturing processes or facilities                                        
 of third-party manufacturers with which we enter into agreement for clinical and commercial supplies, the supply of devices or other materials  
 necessary to conduct clinical trials may be insufficient, inadequate or not available at an acceptable cost, 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.