Company: PFSA
Filing Date: 2025-05-15
Form Type: 424B3
Source: 0001213900-25-044417
Chunk: 437

Company: Profusa, Inc.
Filing Date: 2025-05-15
Form: 424B3
Chunk 437
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 and effectiveness (accuracy and intended use performance) aiming at regulatory clearance purposes, i.e. CE Mark. In parallel the technology is going be presented to FDA to obtain Investigational Device Exemptions for study conduct in the U.S. Potential clinical study sites have been targeted and respective IDE submission documentation is in preparation. A PMA (Pre -MarketApproval) 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 -usedevice 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 -timeuse 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 -termLumee 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 -dependentdiabetes, male and female, of 18 years and older. The study served as Proof -ofConcept 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 Sub