Company: PFSA
Filing Date: 2025-08-22
Form Type: S-1/A
Source: 0001213900-25-079829
Chunk: 191

Company: Profusa, Inc.
Filing Date: 2025-08-22
Form: S-1/A
Chunk 191
---
 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 an upgraded sensor version. Twelve subjects with insulin -dependentdiabetes, 18 years and older have been enrolled. The objective of the study was to evaluate tissue integration, location reliability and glucose response characteristics over a period of three and six months after sensor placement. Correlation of Lumee signals with IV sampled blood reference values was to be established during glucose excursions at meals at repeated in clinic visits. Reader localization effectiveness was checked additionally by using an infrared sensitive camera and by high frequency ultrasound. The active monitoring phase has been completed. Long -termsafety observations are ongoing. • Glucose Monitoring with the Lumee Glucose Hydrogel in the Subcutaneous Tissue:The multi -sitestudy was initiated in Austria, Germany, and Vietnam in August/October 2021. Total of 54 subjects across all sites with insulin -dependentdiabetes, 18 years and older have been enrolled. The objective of the study was to evaluate glucose response characteristic of the Lumee Glucose hydrogel in tissue over a period >3 months with active monitoring sessions and 3 years of placement safety observations. Analysis endpoints did include: Correlation of Lumee signals with IV sampled blood reference values, Signal processing/algorithm effectiveness, correction approaches for motion, temperature, ambient light, signal stability over time. Selected in -clinic24 -hourmonitoring sessions were performed. 119

Demographics For Lumee Glucose Studies A total of 54 subjects have been enrolled with 108 Lumee Glucose sensors injected and 398 study visits completed. These visits have yielded 745 glucose traces and more than 18,000 paired reference points.

| Site        |         |       1 |       2 |      |       3 |       4 |
| Location    |         | Germany | Austria |      | Vietnam | Vietnam |
| Subjects    |         |      12 |      12 |   16 |       7 |       7 |
| Data Sets   |         |     121 |      60 |  124 |      63 |      68 |
| Diabetes    |  Type 1 |      12 |       9 |   15 |       0 |