Company: PFSA
Filing Date: 2025-10-29
Form Type: 424B3
Source: 0001213900-25-103174
Chunk: 201

Company: Profusa, Inc.
Filing Date: 2025-10-29
Form: 424B3
Chunk 201
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 investigational product.                                                                                                               |

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| ● | OMNIA (Oxygen Monitoring Near Ischemic Areas) European Registry Study. This study was a Post-Market                                     
 Follow-up study which explored use cases and characterizing the diagnostic value of the Lumee Oxygen Platform in Critical Limb Ischemia 
 patients. As a registry, the study intended to provide real-world experience and to prepare implementation of the Lumee Oxygen Platform 
 in the European market. Enrollment of the study has concluded with a total of 35 subjects. There was no indication of adverse reactions 
 specific to the hydrogels. Data analysis confirmed Lumee Oxygen is responsive to interventions during revascularization therapies.      |

| ● | Physiology Baseline Data of Tissue Oxygen Levels in Healthy Volunteers. This study was a development                                       
 study was conducted in the U.S. toward the development of a next generation device and was aimed at collecting physiological integration   
 and baseline data of tissue oxygen levels in various anatomical locations and usability data in healthy adult volunteers in daily life     
 using a prototype version of Profusa’s Wireless Lumee Oxygen Platform. The study has been completed, it generated observations to          
 inform wireless technology development, attachment and formfactor design, as well as software considerations for a next generation device. 
 No design changes to Lumee Oxygen will occur prior to regulatory approval of the current existing device. Once FDA marketing authorization 
 has been obtained, any design changes for a next generation of Lumee Oxygen will be planned, implemented, and verified and additional      
 performance data or proof of equivalency will be submitted to FDA in an amendment to the original submission.                              |

| ● | Ongoing Pivotal Study in the U.S. for submission purposes to FDA — Effectiveness                                                          
 of Measuring Local Tissue Oxygen in Response to Induced Hemodynamic Changes with The Profusa Wireless Lumee Oxygen Platform in Patients   
 with PAD. This is an ongoing IDE study in the United States with the objective to assess the effectiveness of monitoring changes          
 in local tissue oxygen with Profusa’s Wireless Lumee Oxygen Platform in comparison to transcutaneous oxygen measurements in patients      
 with peripheral artery disease (PAD). This study characterizes the response to hemodynamic changes, or changes in cardiovascular function 
 such as arterial pressure or cardiac output, induced by vascular occlusion tests and positional maneuvers. The study has been approved    
 for conduct at four study sites with enrollment of up to 65 subjects.                                                                     |

Device Safety

As of November 2024