Clinical Evidence.
Published Data.
Validated Technology.
Profusa's Lumee™ platform is backed by peer-reviewed clinical publications, multi-center human trials, and more than $30M in validation funding from DARPA and NIH. Every claim is supported by data.
Oxygen Platform
Lumee™ Oxygen — Vascular Surgery Data
Published Clinical Study: Journal of Vascular Surgery,
June 2015, Volume 61:6, Pages 1501–1510
June 2015, Volume 61:6, Pages 1501–1510
Key Findings
Clinical Significance: For the first time, vascular surgeons had an objective, continuous measurement of tissue perfusion — not derived from downstream pulse oximetry, but from the actual tissue at risk. This enables real-time surgical course corrections and post-operative monitoring without hospital readmission.
Real-time tissue oxygen data captured continuously throughout PAD/CLI surgical intervention
Post-operative monitoring maintained for 28 days without sensor replacement
Sensor demonstrated low risk to patients throughout the study
Platform provided actionable intra-operative decision support — described as "intra-operative GPS" by clinical investigators
Glucose Platform
Lumee™ Glucose — Multi-Center Human Trial
Clinical sites4 total: 2 European, 2 Asian
Subjects 54 enrolled
Sensors108 injected
Study visits 398 completed
Data points>18,000 paired glucose
reference points |
745 glucose traces
reference points |
745 glucose traces
SafetySafety profile met
Accuracy (MARD) -
Current Development Algorithm10–12%
Current Development Algorithm10–12%
Sensor Functionality confirmed270+ days
MARD = Mean Absolute Relative Difference. 10–12% MARD is clinically competitive with commercially approved devices. Results based on current development data processing and algorithm.
Regulatory Status
EU Regulatory (Lumee™ Oxygen)
✓EU MDR CE Mark update in progress
✓Technical file submission: November 2025
→Compliance testing: December 2025
US Regulatory (Lumee™ Oxygen)
→FDA Submission Process: Q3–Q4 2026
→US Oxygen Revenue: targeted Q1 2027
Lumee™ Glucose US/EU/Asia
→Human Pivotal Study Planning: 2026
→CE/FDA Submission: Q1 2027
→Glucose Revenue: Q3 2027+