Company: PFSA
Filing Date: 2025-10-29
Form Type: 424B3
Source: 0001213900-25-103174
Chunk: 186

Company: Profusa, Inc.
Filing Date: 2025-10-29
Form: 424B3
Chunk 186
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 sophisticated evaluation of biomarkers for both molecular
diagnostics and potentially therapeutic purposes.

Importantly today, Profusa
believes that Lumee’s biosensor and artificial intelligence platform compares very attractively with some of the largest products
in this market sector. Profusa believes its validated core technology can easily bridge the gap that exists in the current technology
landscape for monitoring real time biochemistry. The current approaches either have tailored clinical application at high costs and burdensome
user experiences, such as CGMs today; or broad potential user base in consumer-friendly costs and user experience, but limited clinical
utility, such as health and wellness wearables. Other products are strictly software and analytics-driven solutions such as telemedicine
and coaching apps which have limited clinical utility due to the lack of real time data. Profusa’s technology today has the potential
to provide the solution of bringing sophisticated, real-time to a broad population of needy patients globally at a more reasonable cost.

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Profusa’s core platform
technology is the foundation for its growth strategy, which includes:

| ● | Near term product revenue in Europe from the CE approved Lumee Oxygen which measures dissolved tissue                                    
 oxygen for up to six months following sensor injection. Initial product uses include application for the management of wound care        
 for critical limb ischemia patients in surgical settings, followed by use in ambulatory settings, subject to future regulatory approval. 
 Profusa estimates that the current total addressable market size for critical limb ischemia across the United States and European        
 Union is approximately five million patients. Profusa anticipates beginning commercialization of Lumee Oxygen in Europe in early 2026    
 and continuing its U.S. study for submission for U.S. FDA marketing authorization late 2026. Lumee Oxygen may not be commercialized      
 in the U.S. until FDA marketing authorization has been obtained.                                                                         |

| ● | Future product revenues from Profusa’s second product, Lumee Glucose, a continuous glucose monitoring                                          
 platform, that will provide real time glucose levels for patients suffering from diabetes, subject to regulatory approval. Profusa has         
 generated proof-of-concept clinical data from 54 diabetes subjects over four clinical sites (two in Europe and two in Asia) in human trials.   
 Using Profusa’s current data analytics algorithm, the glucose platform has demonstrated potential for mean absolute relative difference        
 (MARD) of approximately 11% with up to nine months of functionality post injection. To date, there have been zero incidences of device-related