Company: PFSA
Filing Date: 2025-08-25
Form Type: 424B3
Source: 0001213900-25-080387
Chunk: 183

Company: Profusa, Inc.
Filing Date: 2025-08-25
Form: 424B3
Chunk 183
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 insertions, in 35 of subjects, with no device related serious adverse events (SAE). Study results served investigational device development purposes in support of the CE approval of the first generation device in 2016. •Proof -of -Conceptstudy — A Feasibility Study to Characterize the Performance of the PROFUSA Oxygen Sensor System.The first -in -human“Si Se Puede” Study used micro -oxygensensors that were injected into the feet of patients with limb -threateningischemia to measure oxygen changes during endovascular therapy. A total of 48 sensors were studied in 10 CLI patients and 4 healthy volunteers. The injected sensors could be readily located during measurement attempts. There were no adverse events of safety concern related to the investigational product. • Feasibility of Continuous Tissue Oxygen Monitoring in Healthy Adults.This study was an interventional feasibility study that was designed to characterize the performance of the Lumee Oxygen Platform in healthy adult volunteers. The analysis summarized here includes data on multiple study end points, including usability, safety, and effectiveness. Tissue oxygen levels were measured in 7 subjects (total of 14 sensors) during provocation tests that were used to induce changes in peripheral tissue oxygen. During provocations, local tissue oxygen was measured continuously using both Lumee Oxygen sensors and a commercially available transcutaneous oximetry (non -invasivemeasuring of oxygen levels through the skin) device. Results showed that Lumee Oxygen measurements were reliably obtained and provided signals sufficiently above a signal to noise threshold. There were no adverse events of safety concern related to the investigational product. • OMNIA (Oxygen Monitoring Near Ischemic Areas) European Registry Study. This study was a Post -MarketFollow -upstudy which explored use cases and characterizing the diagnostic value of the Lumee Oxygen Platform in Critical Limb Ischemia patients. As a registry, the study intended to provide real -worldexperience and to prepare implementation of the Lumee Oxygen Platform in the European 117 market. Enrollment of the study has concluded with a total of 35 subjects. There was no indication of adverse reactions specific to the hydrogels. Data analysis confirmed Lumee Oxygen is responsive to interventions during revascularization therapies. • Physiology Baseline Data of Tissue Oxygen Levels in Healthy Volunteers.This study was a development study was conducted in the U.S. toward the development of a next generation device and was aimed at collecting physiological integration and baseline data of tissue oxygen levels in various anatomical locations and usability