Company: PFSA
Filing Date: 2025-10-09
Form Type: S-1
Source: 0001213900-25-097860
Chunk: 185

Company: Profusa, Inc.
Filing Date: 2025-10-09
Form: S-1
Chunk 185
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 that was designed to characterize the performance of the Lumee Oxygen Platform in healthy adult volunteers. The analysis 
 summarized here includes data on multiple study end points, including usability, safety, and effectiveness. Tissue oxygen levels were      
 measured in 7 subjects (total of 14 sensors) during provocation tests that were used to induce changes in peripheral tissue oxygen. During 
 provocations, local tissue oxygen was measured continuously using both Lumee Oxygen sensors and a commercially available transcutaneous    
 oximetry (non-invasive measuring of oxygen levels through the skin) device. Results showed that Lumee Oxygen measurements were reliably    
 obtained and provided signals sufficiently above a signal to noise threshold. There were no adverse events of safety concern related to    
 the 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