Key Figures<\/p>\n
\n Pilot phase patients
\n 15 PAD patients
\n
\n U.S. pilot phase Lumee oxygen monitoring study
\n
\n <\/p>\n
\n Monitoring duration
\n 12 months
\n
\n Sensors monitored over one year with scheduled visits
\n
\n <\/p>\n
\n Follow-up schedule
\n Days 2, 10, 90, 180, 365
\n
\n Clinic visit schedule for implanted sensors
\n
\n <\/p>\n
\n Sensor function duration
\n Up to one year
\n
\n Sensors remained functional for long-term monitoring
\n
\n <\/p>\n
\n Adverse events
\n No placement-related events
\n
\n No sensor placement related adverse events reported
\n
\n <\/p>\n
\n EU CLI procedures
\n More than 716,000 annually
\n
\n Annual critical limb ischemia procedures in Europe
\n
\n <\/p>\n
\n Price change pre-news
\n -13.35%
\n
\n 24h move prior to this article
\n
\n <\/p>\n
\n 52-week range
\n 0.1159\u20132.40
\n
\n 52-week low and high before this news
\n
\n <\/p>\n
Market Reality Check<\/p>\n
\n $0.1525
\n Last Close
\n <\/p>\n
\n Volume
\n Volume 8,839,909 is in line with the 20-day average of 8,839,551 (relative volume 1.0x).
\n
\n normal
\n
\n <\/p>\n
\n Technical
\n Shares at 0.1525, trading below the 200-day MA of 0.41 and far under the 52-week high of 2.40.
\n <\/p>\n
\n Peers on Argus
\n
\n
<\/p>\n
PFSA was down 13.35% while key medical device peers like AIMD and ALUR were up 2.25% and 1.83%, respectively, indicating stock-specific pressure rather than a sector move.<\/p>\n
Historical Context<\/p>\n
Pattern Detected<\/p>\n Positive operational, roadmap, and financing updates have often seen muted or negative next-day price reactions, while clinical conference news has aligned more with modest gains.<\/p>\n Recent Company History<\/p>\n Over the last few months, Profusa reported manufacturing readiness for Lumee, laid out a commercialization roadmap with revenue targets through 2030, and detailed third-quarter 2025 financing progress, including debt reduction and PIPE\/ELOC access. It also highlighted multiple clinical data presentations for Lumee oxygen monitoring in PAD, including upcoming sessions at Paris Vascular Insights 2025 and LINC 2026. Historically, clinical communication has coincided with small positive moves, whereas strategic and financial updates have often been followed by share price weakness.<\/p>\n Market Pulse Summary<\/p>\n
Key Terms<\/p>\n
“monitoring is a safe and effective long-term method in PAD patients”<\/p>\n A circulatory condition in which arteries that supply blood to the legs and feet become narrowed or blocked, reducing blood flow and causing pain, slow healing, or tissue damage\u2014think of it as clogged pipes in the body\u2019s lower limbs. It matters to investors because the prevalence, available treatments, and clinical trial or regulatory outcomes shape demand for drugs, devices, and care services, which can affect revenues, costs and valuation in healthcare-related businesses.<\/p>\n
<\/p>\n AI-generated analysis. Not financial advice.<\/p>\n
Data from FDA-advised study demonstrates Lumee\u2122 Oxygen tissue monitoring is a safe and effective long-term method in PAD patients and will support potential FDA submission; strongly correlates with transcutaneous partial pressure of oxygen <\/p>\n BERKELEY, Calif, Dec. 15, 2025 (GLOBE NEWSWIRE) — Profusa, Inc. (\u201cProfusa\u201d or the \u201cCompany\u201d) (Nasdaq: PFSA<\/a>), a commercial stage digital health company pioneering a next-generation technology platform enabling the continuous monitoring of an individual\u2019s biochemistry, presented pilot phase data demonstrating the study\u2019s primary end points were successfully met at the late breaking clinical trial session at the Paris Vascular Insights (PVI) 2025, on December 13, 2025, in Paris, France.\u00a0\u00a0 Data from the FDA-advised clinical study performed in the U.S. (University of California San Francisco, San Francisco VA Medical Center, and San Francisco General Hospital) showed Lumee oxygen tissue monitoring is a safe and effective method for long term monitoring of peripheral artery disease (PAD) patients. The data also demonstrated strong correlation with traditional transcutaneous partial pressure of oxygen (tcpO2).<\/p>\n The presentation, titled, \u201cMonitoring Tissue Oxygen Dynamics with a Novel Implantable Hydrogel Sensor in Patients with Peripheral Arterial Disease,\u201d highlighted pilot phase study results from 15 PAD patients with subcutaneous hydrogel sensors implanted in the arm and foot. Tissue oxygenation was measured using both Lumee sensors and tcpO\u2082. Sensors were monitored over 12 months with visits at days 2, 10, 90, 180, and 365.<\/p>\n Presented Data Highlights:<\/p>\n Lumee oxygen traces strongly correlated with tcpO\u2082Both devices detected oxygen decreases during occlusionSensors remained functional for up to one yearNo sensor placement related adverse events were reported <\/p>\n \u201cOur Lumee oxygen monitoring technology was designed for use both in the clinic and at home. We are pleased by the presented data, which will support our potential U.S. FDA submission and our goal of making long term oxygen tissue monitoring easily accessible at home to improve overall patient outcomes,\u201d said Ben Hwang, Ph.D., Profusa\u2019s Chairman and CEO. \u201cWe are on track to begin commercialization of Lumee tissue oxygen monitoring in the European Union in the beginning of 2Q 2026 and look forward to serving the needs of the PAD market, with more than 716,000 annual critical limb ischemia procedures in Europe.\u201d<\/p>\n About Profusa \u201cLUMEE\u201d, \u201cPROFUSA\u201d and the PROFUSA logo are registered trademarks of Profusa Inc. in the United States, Canada, European Union, China, Japan, South Korea and Australia.<\/p>\n
\n
\n
\n Date
\n Event
\n Sentiment
\n Move
\n Catalyst
\n
\n
\n
\n
\n
\n Dec 11
\n
\n
\n Clinical presentation<\/a>
\n
\n
\n
\n Positive
\n
\n
\n
\n
\n +0.6%
\n
\n
\n
\n US pilot study abstract accepted for LINC 2026 presentation.
\n
\n
\n
\n
\n Nov 24
\n
\n
\n Clinical update<\/a>
\n
\n
\n
\n Positive
\n
\n
\n
\n
\n +8.4%
\n
\n
\n
\n Late-breaking US clinical trial update accepted at PVI 2025.
\n
\n
\n
\n
\n Nov 19
\n
\n
\n Quarterly results<\/a>
\n
\n
\n
\n Positive
\n
\n
\n
\n
\n -6.0%
\n
\n
\n
\n
\n
\n Q3 2025 highlights with debt reduction, PIPE\/ELOC funding and revenue outlook.
\n
\n
\n
\n
\n Oct 30
\n
\n
\n Commercial roadmap<\/a>
\n
\n
\n
\n Positive
\n
\n
\n
\n
\n -9.8%
\n
\n
\n
\n
\n
\n Outlined Lumee commercialization timing and long-term revenue targets.
\n
\n
\n
\n
\n Oct 28
\n
\n
\n Manufacturing update<\/a>
\n
\n
\n
\n Positive
\n
\n
\n
\n
\n -2.1%
\n
\n
\n
\n
\n
\n Completed manufacturing build-out with capacity above 2026 needs.
\n
\n
\n
\n
<\/p>\n
\n The stock is surging +25.9% following this news. A strong positive reaction aligns with the stock\u2019s tendency to respond better to clinical milestones than to strategic or financial updates. Recent history showed modest gains after conference-related clinical news but weakness following roadmap and financing disclosures of up to -9.85%. Investors would need to weigh how durable enthusiasm around endpoint success and safety data might be against prior patterns of volatility and the company\u2019s broader financing and commercialization risks.
\n <\/p>\n
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\n peripheral artery disease
\n
\n medical
\n
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<\/p>\n
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\n 12\/15\/2025 – 07:30 AM
\n
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<\/p>\n
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.<\/p>\n
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