Profusa / Pipeline
Multiple Near-Term Catalysts. A Clear Path to $200–250M Revenue by 2030.
Profusa's commercialization is progressing on three parallel tracks. Each track builds on the same platform, manufacturing infrastructure, and distribution network.
Commercialization Roadmap
Program-by-Program Roadmap
| Program | Q4 2025 – Q2 2026 | Q3 2026 – Q4 2026 | Q1 2027 – Q2 2027 | Q3 2027+ |
|---|---|---|---|---|
| Research & Government | Revenue Begins Q2 2026 | Ongoing Revenue | Ongoing Revenue | Ongoing Revenue |
| Lumee™ Oxygen (EU) | CE Mark + anticipated EU launch | EU Revenue Grows | EU Revenue Grows | EU Revenue Grows |
| Lumee™ Oxygen (US) | Pivotal Study Begins | FDA Submission | US Revenue Launch | US Revenue Grows |
| Mayo Clinic Collaboration | Planning | Product Development | US Revenue Launch | US Revenue Grows |
| Lumee™ Glucose | Data Published + Pivotal Planning | CE/FDA Submission | Approval Process | Glucose Revenue Begins |
Operational Pillars
Six Pillars Driving Revenue
AI & Data Science
NVIDIA AI collaboration active
AI-driven data algorithm in development
Physician decision portal planned
AI-driven data algorithm in development
Physician decision portal planned
Revenue / Commercial
Lumee Oxygen in EU and US
Healthcare Research
Mayo Clinic Collaboration
Lumee Glucose in US and EU
Healthcare Research
Mayo Clinic Collaboration
Lumee Glucose in US and EU
Finance / Resources
$22M PIPE ($12M drawn)
$100M ELOC ($5M drawn)
$100M ELOC ($5M drawn)
Regulatory / Clinical
EU MDR CE Mark
US FDA Pivotal Study — 2026
Glucose CE/FDA — 2027
US FDA Pivotal Study — 2026
Glucose CE/FDA — 2027
Manufacturing / Operations
Sensor lab certified & online
Excess manufacturing capacity ready
Reader outsourced mfg confirmed
Excess manufacturing capacity ready
Reader outsourced mfg confirmed
Future Analytes
Lactate
CO₂
Sodium
Ethanol
CO₂
Sodium
Ethanol