Company: PFSA
Filing Date: 2025-05-09
Form Type: S-4/A
Source: 0001213900-25-041151
Chunk: 447

Company: Profusa, Inc.
Filing Date: 2025-05-09
Form: S-4/A
Chunk 447
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8.6 |
| Min         |       6 |     6.3 |       — |  6.7 |     7.7 |         |
| Max         |     7.9 |     9.3 |       — | 14.8 |     9.4 |         |

Results The feasibility study at the four clinical sites provided data on sensor locatability, system performance (the ability to accurately estimate glucose), in addition to monitoring for adverse events. All the sensors were locatable. The feasibility study was not designed and powered to provide a robust estimate of the commercial performance of the system, however, data collected in the study enabled the refinement of the algorithm. Using the data, Profusa was able to show evidence of the system’s ability to track glucose. Data indicate that the sensors were responsive to glucose during the study period and provided a significant body of data for algorithm development and evaluation. Performance analysis of the data yielded an aggregate mean absolute relative difference (MARD) of 11.7% for sessions from 7 – 90 days post -injection. The consensus error grid and cumulative MARD distribution are presented below, representing 163 sessions from 37 patients that passed the data quality filters, resulting in 2406 paired blood

245 glucose reference points. Data quality filters that were developed and automated during the algorithm development exclude problematic traces including poorly placed readers over the sensor, unexpected fluorescence contamination of the skin surface over the sensor, and poor adhesion of the reader over the sensor yielding low signal to noise. The figure above shows a standard Consensus Error grid, which is a tool used to evaluate the accuracy of blood glucose meters. It visualizes the paired data points that passed the quality filters. This includes 163 sessions of data collection approximately 6 hours in duration from 37 patients over the course of 90 -days. Measured signals are calibrated using 3 -pointblood glucose calibration in each session. Each dot on the figure shows the relationship between the Profusa reported blood glucose value (Y -axis) compared with the corresponding reference measured blood glucose value (X -axis). The colors of the dots distinguish patients. The grid is divided into zones signifying the degree of risk posed by the incorrect measurement: zone A represents no effect on clinical action; zone B represents altered clinical action — little or no effect on clinical outcome; zone C represents altered clinical action — likely to affect clinical outcome; zone D represents altered clinical action — could have significant medical risk; and zone