Company: PFSA
Filing Date: 2025-10-29
Form Type: 424B3
Source: 0001213900-25-103174
Chunk: 203

Company: Profusa, Inc.
Filing Date: 2025-10-29
Form: 424B3
Chunk 203
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 Potential clinical study sites
have been targeted and respective IDE submission documentation is in preparation. A PMA (Pre-Market Approval) pathway is expected for
marketing authorization in the U.S. It will likely require a pivotal study performed in the United States with an estimated
enrollment of 120 – 160 subjects and an active glucose measurement period of at least 3 months.

The first commercial implementation
of Lumee Glucose will be, subject to regulatory approval, a professional-use device for retrospective data download and data evaluation
by health care professionals. This approach is typical in the CGM market and will be a controlled and limited use case in preparation
for the release of a fully featured real-time use CGM device generation in the near future, subject to obtaining required regulatory approval.

Lumee Glucose Clinical Study History

Lumee Glucose is a CGM product
candidate that was first entered into clinical study through our first-in-human (FIH) in 2021. To date, we have tested 108 sensors in
54 subjects in our clinical program for the glucose product. These studies have been conducted in global sites in Germany, Austria, and
Vietnam. No serious adverse events have been reported with safety data for 12 months post injection.

| ● | Proof of Concept Feasibility Assessment: The study was conducted in Germany in 2018/19. The objective                                        
 of the study was to evaluate the Lumee Glucose FIH Platform in human subjects, establishing long-term Lumee Glucose measurements in the      
 subcutaneous interstitial space as representation of glycemia. The Lumee hydrogel signal was to be compared to established glucose reference 
 measurements of capillary blood under controlled conditions for potential signal artefacts like movement, temperature, and ambient light.    
 Initial signal processing algorithms would be established including retrospective accuracy evaluation considering a defined relationship     
 between the Lumee signal and blood glucose reference measurements. 10 subjects had been enrolled with insulin-dependent diabetes, male       
 and female, of 18 years and older. The study served as Proof-of Concept for the technology and for safe use in human. Both the hydrogel      
 sensor and the reader design have been significantly modified since in order to improve sensing sensitivity/responsiveness of the system     
 for the subsequent study.                                                                                                                    |

| ● | Tissue Integration and Monitoring with the Lumee Glucose Hydrogel in the Subcutaneous Interstitium:                                        
 The study was conducted in Austria in 2020/21 employing two versions of the reader system and