Lumee™ Oxygen | Continuous Tissue Oxygen Monitoring for CLI & Wound Care | Profusa

Intra-Operative GPS for
Critical Limb Ischemia —
Objective Tissue Perfusion Data in Real Time

For the first time, vascular surgeons have an objective, continuous measurement of tissue oxygen levels throughout CLI intervention and for 28 days post-operatively — enabling data-driven decisions that were previously impossible.

EU CE Mark Target
April 2026
GMED approval process underway
US FDA Pivotal Study
Q1 2026
US revenue launch targeted 2027
Post-Op Monitoring
28 Days
Continuous, without sensor replacement
The Clinical Problem

Clinicians Deserve More Than Clinical Intuition

Today, approximately 6.5 million patients globally suffer from Critical Limb Ischemia — a severe blockage of the arteries that reduces blood flow and oxygen to the limbs. Despite more than 1.1 million procedures performed annually in the US and EU, treatment decisions remain largely based on clinical experience alone. There is currently no tool that provides objective, real-time data about tissue perfusion during or after intervention.

Lumee™ Oxygen changes that.

6.5M
Patients with Critical Limb Ischemia in the US, Europe, and Japan
1.1M
CLI procedures annually in the US and EU combined
$4.9B
CLI treatment market in 2022, growing at 8% CAGR
0
Objective real-time tissue perfusion tools available to clinicians today
Product

Real-Time Tissue Oxygen Data.
Delivered Continuously.

The Lumee™ Oxygen system includes three components:

Component 01
Lumee™ Oxygen Hydrogel Sensor

Injected subcutaneously at the site of interest via standard hypodermic needle. Remains in place and functional for up to 9+ months with no surgical removal required.

Component 02
Lumee™ Patch

Worn on the skin over the sensor site. Reusable optoelectronic reader that continuously interrogates the sensor and transmits data via Bluetooth.

Component 03
Lumee™ App

iOS/Android compatible application displays real-time Lumee Oxygen Index (LOI). Enables remote patient monitoring.

📋
Validated in Published Clinical Studies

Published in the Journal of Vascular Surgery (June 2015, Volume 61:6, 1501–10), the Lumee™ Oxygen Platform demonstrated:

• Accurate reporting of local tissue oxygen levels during PAD/CLI surgical intervention
• Continuous post-operative monitoring for 28 days
• Low patient risk profile throughout the study period
• Real-time intra-operative data enabling objective surgical decision-making

View Clinical Evidence →
Market Opportunity
Global CLI Market
  • ~6.5M patients in US, Europe, and Japan
  • ~$4.9B market in 2022 growing at 8% CAGR
  • ~1.1M CLI procedures annually (US + EU)
  • 716,000 EU procedures estimated in 2025
  • 425,000 US procedures estimated in 2025
EU Commercial Focus (Tier 1)
  • Germany: ~110,000 procedures/year
  • France: ~60,000 procedures/year d
  • Italy: ~50,000 procedures/year
  • Tier 2: Austria, Benelux, Switzerland, Greece
  • Distribution covering ~35% of EU procedures already secured
Revenue Model

A Clear Revenue Model at Scale

Revenue StreamPriceUnit
Procedure Revenue€600 – €800 per procedure4 sensors + 4 pens per CLI case
Starter Kit €10,000 per kit iPad + preloaded software + sensors + adhesives
Kits per Center3 kits per center/yearCovers 1,000–1,500 high-volume or 200–1,000 ambulatory procedures
Distribution Partners

EU Launch Partners

Current confirmed distribution partnerships:

AngioPro (Germany) — Covers ~30% of EU population, access to key European markets

Dismeval, S.L. (Spain) — Covers Spanish CLI procedure volume

Key Clinical Centers of Excellence already engaged:

Austria Medical Center — Dr. Marianne Brodmann (~1,500 procedures/year)

Paris Vascular Center — Dr. Yann Goeffic (~8% of France's CLI procedures)

Belgium Vascular Center — Dr. Koen R. Deloose

Expansion Planned
Additional Partners

Further distribution partnerships planned to expand EU market coverage beyond the current ~35%.

For Investors

See the full EU revenue roadmap, financial projections, and funding runway.

View Financial Overview→
For Clinicians

Request clinical data, ask about EU availability, or schedule a product demonstration.

Request Clinical Info →