Company: PFSA
Filing Date: 2025-10-29
Form Type: 424B3
Source: 0001213900-25-103174
Chunk: 13

Company: Profusa, Inc.
Filing Date: 2025-10-29
Form: 424B3
Chunk 13
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| ● | We expect the commercialization of the Lumee Oxygen Platform to generate nearly all our commercial revenue 
 until we obtain regulatory approval for additional products.                                               |

| ● | We depend upon third-party suppliers and outsource to other parties, making us vulnerable to supply disruptions, 
 suboptimal quality, noncompliance and/or price fluctuations, which could harm our business.                      |

Risks Related to Healthcare Industry Shifts and Changing Regulations

| ● | There is no guarantee that the FDA will grant 510(k) clearance or PMA approval of our products, and                                  
 failure to obtain necessary clearances or approvals for our future products would adversely affect our ability to grow our business. |

| ● | If we are unable to successfully complete the pre-clinical studies or clinical trials necessary to support                           
 additional PMA, De Novo, or 510(k) applications or supplements, we may be unable to commercialize our CGM systems under development, 
 which could impair our business, financial condition and operating results.                                                          |

| ● | Our products may cause or contribute to adverse medical events or be subject to failures or malfunctions                                       
 that we are required to report to the FDA, and if we fail to do so, we would be subject to sanctions that could harm our reputation, business, 
 financial condition and results of operations. The discovery of serious safety issues with our products, or a recall of our products either    
 voluntarily or at the direction of the FDA or another governmental authority, could have a negative impact on us.                              |

| ● | Quality problems could lead to recalls or safety alerts, reputational harm, and could have a material 
 adverse effect on our business, results of operations, financial condition and cash flows.            |

| ● | Our current or future products may be subject to product recalls even after receiving FDA clearance or                                
 approval. A recall of our products, either voluntarily or at the direction of the FDA, or the discovery of serious safety issues with 
 our products, could have a significant adverse impact on us.                                                                          |

| ● | Changes to the regulatory landscape may impact our ability to obtain marketing authorization for future 
 product developments.                                                                                   |

| ● | Our failure to comply with laws, regulations and contract requirements relating to reimbursement of health                             
 care goods and services may subject us to penalties and adversely impact our reputation, business, financial condition and cash flows. |

| ● | We are subject to complex and evolving U.S. and foreign laws and regulations and other