Profusa Receives Purchase Orders for Lumee™ Tissue Oxygen Monitoring and Raises 2026 Revenue Guidance
Rhea-AI Summary
Profusa (Nasdaq: PFSA) received European purchase orders for its Lumee™ tissue oxygen monitoring system and raised 2026 revenue guidance to $1.5M–$3.0M (previously $0.5M–$2.0M).
The company is building inventory, expects CE Mark migration under EU MDR to complete in Q2 2026 to enable shipments, and cites clinical momentum and a Mayo Clinic collaboration supporting potential U.S. entry in late 2026.
AI-generated analysis. Not financial advice.
Positive
- Revenue guidance raised to $1.5M–$3.0M for 2026
- Multiple purchase orders from European distributors and physician customers
- Inventory being built to support shipments beginning 2Q2026
- Mayo Clinic collaboration strengthens clinical credibility
Negative
- Order fulfillment contingent on MDR migration and regulatory clearance in Europe
- 2026 revenue remains relatively small at $1.5M–$3.0M
News Market Reaction – PFSA
On the day this news was published, PFSA declined 4.52%, reflecting a moderate negative market reaction. Argus tracked a peak move of +50.7% during that session. Argus tracked a trough of -2.1% from its starting point during tracking. Our momentum scanner triggered 15 alerts that day, indicating notable trading interest and price volatility. This price movement removed approximately $114K from the company's valuation, bringing the market cap to $2.41M at that time. Trading volume was very high at 3.1x the daily average, suggesting heavy selling pressure.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
PFSA was down 5.85% while peers showed mixed to positive moves: AIMD up 1.5% and ALUR up 5.56%. Momentum scanner names like INBS (+10.35%) and AIMD (+7.41%) were moving higher, suggesting PFSA’s weakness diverged from pockets of strength in related medical device names.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Feb 12 | Strategic collaboration | Positive | +2.7% | Mayo Clinic collaboration on Lumee oxygen monitoring applications for critical indications. |
| Feb 05 | Capital structure change | Negative | -36.4% | 1-for-75 reverse stock split consolidating shares and changing capital structure. |
| Jan 29 | Clinical trial update | Positive | -3.4% | Positive US pilot study results for Lumee oxygen sensors presented at LINC 2026. |
| Jan 16 | Product launch | Positive | +4.1% | Launch of Lumee tissue oxygen Healthcare Research offerings, initiating first commercial revenue. |
| Jan 08 | Customer expansion | Positive | +0.1% | Addition of a leading Greek vascular surgeon adopting Lumee Oxygen in clinical practice. |
Recent positive operational and clinical updates often saw modest gains, while financing or structural actions, such as the reverse split, coincided with sharp declines. One prior positive clinical event also drew a negative reaction, suggesting occasional skepticism toward favorable news.
Over early 2026, Profusa has steadily built the Lumee™ Oxygen franchise. A January 2026 announcement added a leading Greek vascular surgeon, followed by the launch of Lumee Healthcare Research offerings on Jan 16, initiating first commercial revenue. Positive US pilot data at LINC 2026 and a Mayo Clinic collaboration on Feb 12 reinforced clinical and strategic momentum. Against this backdrop, today’s raised 2026 revenue guidance and European purchase orders extend the commercialization narrative begun with these earlier milestones.
Market Pulse Summary
This announcement highlights a step-up in internal expectations, with 2026 revenue guidance raised to $1.5–$3 million on the back of European purchase orders for the Lumee tissue oxygen system. It also underscores upcoming regulatory milestones, including EU MDR migration targeted for Q2 2026 and a CE Mark update in 1Q2026. Investors may track progress on MDR completion, timing of anticipated April 2026 approval, and the pace of both European adoption and Healthcare Research revenues.
Key Terms
tissue oxygen monitoring system medical
chronic limb threatening ischemia medical
ce mark regulatory
european union medical device regulation regulatory
medical device regulation (mdr) regulatory
AI-generated analysis. Not financial advice.
With strong underlying market demand, European distributor and expert physician customer purchase orders are being received by the Company as its 2026 revenue guidance range increases to
BERKELEY, Calif, Feb. 19, 2026 (GLOBE NEWSWIRE) -- Profusa, Inc. (“Profusa” or the “Company”) (Nasdaq: PFSA), a commercial stage digital health company pioneering the next generation of technology platform enabling the continuous monitoring of an individual’s biochemistry, announces it has received several purchase orders for the Lumee™ tissue oxygen monitoring system from its growing network of European distributors and expert physician customers. With strong underlying market demand, Profusa increased its internal projections, and is subsequently increasing its revenue guidance range for 2026, to
“Our team is focused on establishing our commercial operations and building out broad European market coverage with distributors and expert physician customers. In the past two months, prominent vascular surgeons presented positive data from clinical studies conducted in the United States at the 2026 Leipzig Interventional Course in Germany and the 2025 Paris Vascular Insights in France. These positive results continue to validate the Lumee Oxygen’s clinical value for Chronic Limb Threatening Ischemia (CLTI) treatment. Momentum in the clinical community is increasing. We believe surgeons are anxious to incorporate Lumee Oxygen into their procedures. Surgeons and distributors have issued purchase orders in anticipation of regulatory approval as soon as April 2026. We previously received CE Mark approval under the prior European regulatory framework; however, our ability to fulfill these purchase orders remains contingent upon completion of its migration to comply with the European Union Medical Device Regulation, which the Company currently anticipates finalizing in the second quarter of 2026. Our operations team is already building inventory to support anticipated demand and enable revenue generation early in the second quarter of 2026.
“We believe that with the rapid adoption of the Lumee Oxygen product by surgeons in Europe and our recently announced collaboration with the Mayo Clinic, we are well positioned to potentially enter the US market as soon as late 2026. With additional focus on our Healthcare Research business, we expect revenue to build throughout 2026.
“Given the demand resulting in purchase orders for Lumee Oxygen in Europe and progress we are making in the Healthcare Research business, we have increased our internal revenue projections, and we are raising our revenue guidance range for 2026 to
Profusa intends to provide an update on its European CE Mark approval via GMED under EU Medical Device Regulation (MDR) in 1Q2026, which will catalyze product shipments beginning 2Q2026.
About Profusa
Based in Berkeley, Calif., Profusa is a commercial stage digital health company led by visionary scientific founders, an experienced management team and a world-class board of directors in the development of a new generation of tissue-integrated sensors to detect and continuously transmit actionable, medical-grade data for personal and medical use. With its long-lasting, injectable and affordable biosensors and its intelligent data platform, Profusa aims to provide people with a personalized biochemical signature rooted in data that clinicians can trust and rely on.
“LUMEE”, “PROFUSA” and the PROFUSA logo are registered trademarks of Profusa Inc. in the United States, Canada, European Union, China, Japan, South Korea and Australia.
For more information, visit https://profusa.com.
Special Note Regarding Forward-Looking Statements
Certain statements in this press release (this “Press Release”) may be considered “forward-looking statements” within the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements generally relate to future events or future financial or operating performance of Profusa. In some cases, you can identify forward-looking statements by terminology such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “forecast,” “future,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “propose,” “seek,” “should,” “strive,” “will,” or “would” or the negatives of these terms or variations of them or similar terminology. Such forward-looking statements are subject to risks, uncertainties, and other factors which may be beyond the control of Profusa and could cause actual results to differ materially from those expressed or implied by such forward-looking statements including, without limitation, risks related to the timing, receipt, fulfillment, size, or cancellation of purchase orders, the possibility that purchase orders may not be received or may not result in revenue at the levels anticipated, and the risk that customer demand may be less than expected. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Profusa and its management are inherently uncertain. Profusa cautions you that these statements are based on a combination of facts and factors currently known and projections of the future, which are inherently uncertain. There are risks and uncertainties described in the definitive proxy/final prospectus relating to the business combination, which has been filed with the SEC, and in other documents filed by Profusa from time to time with the SEC. These filings may identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Profusa cannot assure you that the forward-looking statements in this communication will prove to be accurate.
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