Company: PFSA
Filing Date: 2025-10-09
Form Type: S-1
Source: 0001213900-25-097860
Chunk: 13

Company: Profusa, Inc.
Filing Date: 2025-10-09
Form: S-1
Chunk 13
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 to complex and evolving U.S. and foreign laws and regulations and other requirements                                          
 regarding privacy, data protection, security, and other matters. Many of these laws and regulations are subject to change and uncertain      
 interpretation, and could result in claims, changes to our business practices, monetary penalties, increased cost of operations, or declines 
 in user growth or engagement, or otherwise harm our business.                                                                                |

| ● | Cybersecurity risks and cyber incidents could result in the compromise of confidential data or critical                                      
 data systems and give rise to potential harm to customers, remediation and other expenses, expose us to liability under HIPAA, consumer      
 protection laws, or other common law theories, subject us to litigation and federal and state governmental inquiries, damage our reputation, 
 and otherwise be disruptive to our business and operations.                                                                                  |

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 or suits.              |

| ● | We may be involved in lawsuits to protect or enforce our patents or the patents of our licensors, which 
 could be expensive, time-consuming and unsuccessful.                                                    |

| ● | We may not be able to protect our intellectual property rights throughout the world, which could materially, 
 negatively affect our business.                                                                              |

| ● | If we are unable to protect the confidentiality of our trade secrets, the value of our technology could 
 be materially adversely affected and our business could be harmed.                                      |

| ● | We may need or may choose to obtain licenses from third parties to advance our research or allow commercialization     
 of our current or future products, and we cannot provide any assurances that we would be able to obtain such licenses. |

| ● | Obtaining and maintaining our patent protection depends on compliance with various procedural requirements,                              
 document submission, fee payment and other requirements imposed by government patent agencies and our patent protection could be reduced 
 or eliminated for non-compliance with these requirements.                                                                                |

| ● | If we do not obtain patent term extension and/or data exclusivity for any product candidates we decide 
 to develop as drug product candidates, our business may be materially harmed.                          |

6 General Risks of Profusa’s Business

| ● | If we are unable to