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Profusa Bolsters European Commercial Network with New French Distributor, MedSell

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Profusa (NASDAQ: PFSA) announced a distribution partnership with MedSell to commercialize Lumee™ Oxygen tissue monitoring in France, expanding European coverage that now reaches roughly 200,000 CLI cases annually across the EU. The agreement complements a clinical collaboration with Pr. Yann Gouëffic, whose practices represent about 8% of CLTI cases in France. Profusa plans European commercialization beginning 2Q 2026 and targeting US commercialization in 2027, and provided revenue targets of $0.5–2M in 2026, $9–13M in 2027, and a potential goal of $200–250M by 2030.

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Positive

  • European reach: ~200,000 annual CLI cases represented
  • French distribution via MedSell for hospitals and clinics
  • KOL adoption covering ~8% of France CLTI cases
  • 2027 revenue guidance of $9–13M

Negative

  • Low near-term revenue guide: $0.5–2M for 2026
  • US commercialization targeted only in 2027, delaying US revenue

News Market Reaction – PFSA

-13.96%
17 alerts
-13.96% News Effect
+5.5% Peak Tracked
-15.3% Trough Tracked
-$1M Valuation Impact
$8M Market Cap
1.0x Rel. Volume

On the day this news was published, PFSA declined 13.96%, reflecting a significant negative market reaction. Argus tracked a peak move of +5.5% during that session. Argus tracked a trough of -15.3% from its starting point during tracking. Our momentum scanner triggered 17 alerts that day, indicating notable trading interest and price volatility. This price movement removed approximately $1M from the company's valuation, bringing the market cap to $8M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Annual CLI cases: 200,000 cases French CLTI share: 8% 2030 revenue target: $200–$250 million +4 more
7 metrics
Annual CLI cases 200,000 cases Approximate annual CLI cases reached in EU via distributors
French CLTI share 8% Approximate share of all CLTI cases covered by Pr. Gouëffic’s practices in France
2030 revenue target $200–$250 million Management’s potential revenue goal by 2030
2026 revenue potential $0.5–$2 million Management’s potential revenue range for 2026
2027 revenue potential $9–$13 million Management’s potential revenue range for 2027
EU commercialization timing 2Q 2026 Planned start of European Lumee Oxygen commercialization
U.S. Lumee timing 2027 Goal to address the U.S. Lumee oxygen opportunity

Market Reality Check

Price: $1.01 Vol: Volume 821,272,569 is 15....
high vol
$1.01 Last Close
Volume Volume 821,272,569 is 15.61x the 20-day average of 52,611,133 shares. high
Technical Price 0.1218 is trading below the 200-day MA at 0.38, far under the $2.40 52-week high.

Peers on Argus

Peer moves are mixed to negative, with AIMD down 9.09% and ALUR down 2.33%, whil...

Peer moves are mixed to negative, with AIMD down 9.09% and ALUR down 2.33%, while ALRT, TMDI, and LHDX show 0% change, suggesting stock-specific factors for PFSA.

Historical Context

5 past events · Latest: Dec 30 (Positive)
Pattern 5 events
Date Event Sentiment Move Catalyst
Dec 30 Debt restructuring Positive +78.3% Restructured senior secured convertible notes to increase floor and reduce dilution risk.
Dec 15 Clinical results Positive -19.9% U.S. Lumee study met primary endpoints in PAD patients with up to 12-month follow-up.
Dec 11 Conference data Positive +0.6% Acceptance of U.S. Lumee pilot study abstract for LINC 2026 presentation.
Nov 24 Conference update Positive +8.4% Late Breaking Clinical Trial Update on Lumee oxygen monitoring at Paris Vascular Insights.
Nov 19 Earnings & business Positive -6.0% Q3 highlights with debt reduction, PIPE and ELOC funding, and long-term revenue targets.
Pattern Detected

Recent news is mostly positive, but price reactions have been split, with both strong gains and notable selloffs following favorable clinical and financing updates.

Recent Company History

Over the past months, Profusa reported multiple milestones around its Lumee™ platform and capital structure. A note restructuring on Dec 30, 2025 coincided with a +78.33% move, while positive U.S. study results on Dec 13, 2025 saw a -19.87% reaction. Conference-focused clinical updates in November produced modest gains, and third-quarter highlights on Nov 19, 2025 with debt reduction and defined revenue targets led to a -5.95% move. Today’s European commercialization expansion fits into this ongoing commercialization and financing narrative.

Market Pulse Summary

The stock dropped -14.0% in the session following this news. A negative reaction despite commerciall...
Analysis

The stock dropped -14.0% in the session following this news. A negative reaction despite commercially focused news would fit a pattern where some prior positive milestones, including clinical updates and business highlights, were followed by declines of -19.87% and -5.95%. Such a response could reflect market sensitivity to execution risk around the planned 2Q 2026 European launch and 2027 U.S. opportunity, as well as the company’s reliance on achieving its targeted revenue ramp to $200–$250M by 2030.

Key Terms

critical limb threatening ischemia, endovascular, tissue oxygen perfusion, outpatient care
4 terms
critical limb threatening ischemia medical
"large population of patients in France with Critical Limb Threatening Ischemia (CLTI)"
A severe form of peripheral artery disease in which blood flow to a leg or foot is so poor that tissue is at high risk of non-healing wounds, gangrene, or amputation. Think of it like a plumbing blockage that starves a garden patch of water until plants die; for investors, it signals a clear need for medical devices, drugs, procedures and long-term care services that can drive product demand, regulatory attention and healthcare spending.
endovascular medical
"before revascularization, during endovascular or open surgical procedures, and throughout follow-up"
Endovascular describes medical procedures performed inside blood vessels using thin tubes, wires, and implantable devices guided by imaging—like repairing a broken pipe from the inside rather than opening the wall. It matters to investors because these less-invasive techniques can shorten hospital stays, lower complication rates and create demand for specialized devices and imaging equipment, so changes in adoption, regulation or reimbursement can materially affect healthcare company revenues and margins.
tissue oxygen perfusion medical
"The device enables the measurement of tissue oxygen perfusion before revascularization"
Tissue oxygen perfusion is the process by which oxygen carried in the bloodstream is delivered to and taken up by cells in organs and tissues; think of blood as delivery trucks dropping off oxygen packages to factories that need fuel to work. For investors, it matters because measurements or improvements in perfusion show whether a drug, medical device or procedure actually restores or enhances tissue health, which affects clinical outcomes, regulatory approval chances and commercial demand.
outpatient care medical
"commercialize Lumee Oxygen tissue monitoring in France in both hospital settings and outpatient care"
Outpatient care is medical treatment and services provided without an overnight hospital stay, including clinic visits, same-day surgeries, diagnostic tests and rehabilitation. Investors care because outpatient services tend to cost less, can be delivered at many locations, and scale more predictably than inpatient treatment—like a chain of neighborhood stores versus a single full-service hotel—so changes in outpatient demand, pricing and reimbursement affect healthcare revenue mix, margins and capital spending.

AI-generated analysis. Not financial advice.

MedSell commercializes Lumee™ Oxygen tissue monitoring in France, building upon distributor partnerships in Spain, Germany, the Benelux countries, Austria, the United Kingdom, and Scandinavia, to now reach approximately 200,000 annual CLI cases in the European Union

Agreement complements KOL collaboration with Vascular Center at Groupe Hospitalier Paris Saint Joseph, Paris that accounts for approximately 8% of all CLTI cases in France

BERKELEY, Calif, Dec. 31, 2025 (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 a new distributor partnership in France with MedSell.  MedSell is a French company that specializes in the commercialization and distribution of innovative medical devices within the French healthcare market by leveraging tailored commercial, marketing, and market-entry support services.  As part of its portfolio, Profusa’s new partner will commercialize Lumee Oxygen tissue monitoring in France in both hospital settings and outpatient care, especially in wound care and healing clinics addressing patients with complex and chronic wounds.

Benoit Salaün, Pharm.D., Ph.D., MedSell General Manager, said, “Our collaboration with Profusa stems from our particular interest in Lumee Oxygen tissue monitoring for the large population of patients in France with Critical Limb Threatening Ischemia (CLTI). The device enables the measurement of tissue oxygen perfusion before revascularization, during endovascular or open surgical procedures, and throughout follow-up in hospitals or wound care clinics. We believe Lumee Oxygen tissue monitoring meets a critical unmet clinical need and can bring significant added value to clinicians by supporting decision-making and patient monitoring across the entire treatment pathway.”

With MedSell, Profusa builds upon previously announced distributor partnerships in Spain, Germany, the Benelux countries, Austria, the United Kingdom, and Scandinavia, to now represent more than 200,000 CLI cases annually in the European Union.  Further, the distribution partnership with MedSell complements Profusa’s previously announced collaboration with Yann Gouëffic, M.D., Ph.D., professor of vascular surgery in the Vascular Center at Groupe Hospitalier Paris Saint Joseph, Paris, France and a leading surgeon in the field of critical limb threatening ischemia (CLTI). Under the agreement, Pr. Gouëffic adopts Lumee™ oxygen monitoring technology in his practice and in clinical studies that advance application of Lumee for home monitoring. Pr. Gouëffic and his associated practices account for approximately 8% of all CLTI cases in France.

"We are focused on executing on our commercial strategies, including plans to potentially achieve $200 to $250 million in revenue by 2030; capitalize on the near-term as we begin to commercialize in Europe in 2Q 2026  with the goal of addressing the US Lumee oxygen opportunity in 2027.  We expect to deliver 2026 potential revenue of $0.5 to $2 million and $9 to $13 million potential revenue in 2027,” said Ben Hwang, Ph.D., Profusa’s Chairman and CEO.  “The European clinical community continues to validate our Lumee Oxygen tissue monitoring, including recent presentations of US-based clinical trial data at Paris Vascular Insights and Leipzig Interventional Course.  We are committed to making our oxygen tissue monitoring platform easily accessible both at the clinic and at home to improve overall patient outcomes and reduce healthcare costs.”

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. 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.

Contacts
Investor and Media Contacts
email:  info@coreir.com
phone:  1 (212) 655-0924


FAQ

What does Profusa's MedSell distribution deal mean for PFSA shareholders?

The deal expands European commercial coverage to ~200,000 CLI cases annually, supporting early commercial rollout in France.

When will Profusa start commercializing Lumee in Europe (PFSA)?

Profusa expects to begin European commercialization in 2Q 2026.

What revenue guidance did Profusa (PFSA) give for 2026 and 2027?

Profusa provided potential revenue of $0.5–2M for 2026 and $9–13M for 2027.

How significant is Pr. Yann Gouëffic's collaboration for Profusa (PFSA) in France?

Pr. Gouëffic and his practices account for approximately 8% of CLTI cases in France, supporting clinical adoption and studies.

Will Lumee Oxygen be available for home monitoring according to Profusa (PFSA)?

The agreement supports clinical studies advancing Lumee for home monitoring applications.
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