Company: PFSA
Filing Date: 2025-10-29
Form Type: 424B3
Source: 0001213900-25-103174
Chunk: 200

Company: Profusa, Inc.
Filing Date: 2025-10-29
Form: 424B3
Chunk 200
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 has been tested in measuring changes in oxygen in specific
tissues due to systemic oxygen challenges (hypoxia model), peripheral flow disturbances (occlusion/reperfusion protocols and monitoring
of vascular interventions), and wound healing state (ulcerated feet in peripheral artery disease). Because of its small footprint and
a portable design, the Wireless Lumee Oxygen Platform especially provides a method for continuous and long-term monitoring of tissue oxygen
levels.

Lumee Oxygen Clinical Study History

The Wireless Lumee Oxygen Platform
had been registered in various European countries upon CE Mark following a determination that it was equivalent to its predecessor platform,
Lumee Oxygen Platform. The sensors involved are the same. The following is a description of Profusa’s clinical study history for
this product from proof-of-concept through approval in Europe. To date, these clinical studies have involved 140 sensor insertions, in
35 of subjects, with no device related serious adverse events (SAE). Study results served investigational device development purposes
in support of the CE approval of the first generation device in 2016.

| ● | Proof-of-Concept study — A Feasibility Study to Characterize the Performance of the                                                   
 PROFUSA Oxygen Sensor System. The first-in-human “Si Se Puede” Study used micro-oxygen sensors that were injected into                
 the feet of patients with limb-threatening ischemia to measure oxygen changes during endovascular therapy. A total of 48 sensors were 
 studied in 10 CLI patients and 4 healthy volunteers. The injected sensors could be readily located during measurement attempts. There 
 were no adverse events of safety concern related to the investigational product.                                                      |

| ● | Feasibility of Continuous Tissue Oxygen Monitoring in Healthy Adults. This study was an interventional                                     
 feasibility study 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