Welcome to our dedicated page for Profusa news (Ticker: PFSA), a resource for investors and traders seeking the latest updates and insights on Profusa stock.
Profusa, Inc. (Nasdaq: PFSA) is a commercial stage digital health and medical technology company based in Berkeley, California, focused on tissue-integrated biosensors and its Lumee Oxygen tissue monitoring platform. The Profusa news feed on this page aggregates company press releases and third-party coverage related to its technology, clinical studies, commercial partnerships and capital markets activity.
Readers can expect technology and clinical news about Lumee Oxygen tissue monitoring, including study results in peripheral artery disease (PAD) and critical limb threatening ischemia (CLTI). Profusa has reported pilot phase data from a U.S.-based clinical study showing that Lumee oxygen traces strongly correlated with transcutaneous partial pressure of oxygen and that sensors remained functional for up to one year without sensor placement-related adverse events. News items also cover presentations at major vascular conferences such as Paris Vascular Insights and the Leipzig Interventional Course (LINC), where Profusa discusses additional insights into tissue oxygen monitoring.
The PFSA news stream also highlights commercial and distribution developments. Profusa has announced distributor partnerships in European markets for Lumee Oxygen tissue monitoring, including agreements intended to cover significant portions of the European Union population and to serve hospital and outpatient wound care settings. Additional releases describe collaborations with leading vascular surgeons and vascular centers in France and Greece, where Lumee technology is being adopted in clinical practice and clinical studies.
Investors will find corporate and financing updates in Profusa’s news, including details on its business combination with NorthView Acquisition Corporation, recapitalization efforts, senior secured convertible notes, and equity line of credit arrangements. The company has also outlined its own revenue targets and commercialization timelines in press releases, along with manufacturing milestones such as completion of sensor production runs and engagement of contract manufacturers for Lumee components.
By following this PFSA news page, users can track how Profusa communicates progress on its Lumee Oxygen platform, clinical validation, European commercialization plans, and balance sheet restructuring, as disclosed through its public announcements.
Profusa (Nasdaq: PFSA) announced on January 8, 2026 that Dr. Theodosios Bisdas, Head of Clinic of Vascular Surgery at Athens Medical Center, will adopt the Lumee™ Oxygen tissue monitoring platform in his clinical practice in Greece and in clinical studies for home monitoring.
The agreement covers clinical integration for inpatient and outpatient care and continued evaluations of additional vascular applications. Dr. Bisdas has led major multicenter vascular research, published over 100 scientific articles, and founded Vascupedia, a platform with over 10,000 users in 124 countries. Profusa described the collaboration as an expansion of its vascular surgeon network at the Athens Medical Center.
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.
Profusa (Nasdaq: PFSA) announced a restructuring of its Senior Secured Convertible Notes on December 30, 2025 to provide greater repayment flexibility and reduce dilution.
Key changes include an increase in the conversion floor price to $0.35 from $0.10, elimination of mandatory cash and equity amortization payments originally scheduled to begin Q1 2026, a final scheduled payment due at note maturity (18 months after issuance), and higher mandatory ELOC payments that rise from 17.5% to 33% for shares issued under the existing registration statement and to 50% for shares issued under any Form S-1 filed after this date.
Profusa (Nasdaq: PFSA) presented FDA-advised pilot phase results at Paris Vascular Insights on Dec 13, 2025 showing its Lumee™ implantable hydrogel sensors met primary end points for long-term tissue oxygen monitoring in peripheral artery disease (PAD) patients.
Key facts: 15 PAD patients were followed up to 12 months with visits on days 2, 10, 90, 180, 365; Lumee traces strongly correlated with transcutaneous partial pressure of oxygen (tcpO2); sensors remained functional up to one year; no sensor placement–related adverse events were reported. Results are said to support a potential U.S. FDA submission and a planned EU commercialization start in early 2Q 2026.
Profusa (Nasdaq: PFSA) announced that an abstract from its US pilot clinical study of the Lumee tissue oxygen monitoring technology in peripheral artery disease (PAD) patients was accepted for presentation at Leipzig Interventional Course (LINC) 2026.
The presentation is scheduled for January 28, 2026 at 9:45am CET in Trade Fair Leipzig, Hall 2, and will share additional clinical insights comparing Lumee tissue oxygen monitoring with tcpO2 from US sites. The company describes Lumee as a continuous, real-time implantable oxygen sensor intended for clinic and at-home use. Management highlighted positive feedback from the US study and plans to discuss results with providers and researchers at the conference.
Profusa (Nasdaq: PFSA) announced acceptance of a Late Breaking Clinical Trial Update presentation at Paris Vascular Insights 2025, Dec 11-13, 2025, in Paris.
The presentation, by Peter Schneider, M.D., is titled "Monitoring Tissue Oxygen Dynamics with a Novel Implantable Hydrogel Sensor in Patients with Peripheral Arterial Disease (PAD)" and is scheduled for Dec 13, 2025, 13:00–13:40 CET at Carrousel du Louvre. The update covers a U.S.-based clinical study of the Lumee oxygen tissue monitoring platform using transcutaneous partial pressure of oxygen (tcpO2) to measure continuous, real-time tissue oxygen dynamics.
Profusa (Nasdaq: PFSA) reported third-quarter 2025 results and business highlights on Nov 19, 2025. Key outcomes include a completed reverse recapitalization with NorthView, a company equity value of $155 million, and a manufacturing build-out on track for early 2026 product shipments.
Financing actions lowered net debt from $48 million last quarter to $16 million in 3Q and $14 million as of Oct 31, 2025; the company raised $12 million from a convertible PIPE (with $10 million available) and $7 million from an ELOC (with $93 million available). Cash and cash equivalents were $4 million. Management reiterated potential revenue of $0.5–$2M in 2026, $9–$13M in 2027, and a long-term target of $200–$250M by 2030.
Profusa (Nasdaq: PFSA) outlined a commercialization and revenue roadmap anchored by its Lumee tissue-integrated biosensor platform. The company expects EU commercialization in 2Q 2026 with CE GMED certification anticipated in late 1Q 2026 and projects €600–€800 per procedure and equipment revenue of €30,000–€40,000 per center per year. Profusa stated ~35% European population coverage via intended distributors and forecasted potential revenue of $0.5–$2M in 2026, $9–$13M in 2027, and $200–$250M by 2030.
The company plans US Lumee oxygen launch in 1Q 2027 and EU Lumee glucose in mid-2027, and cited addressable markets and additional analytes that could contribute to 2030 targets.
Profusa (Nasdaq: PFSA) completed key manufacturing milestones and says it is on track to begin product shipments and generate revenue in early Q2 2026 for its Lumee tissue oxygen monitoring systems.
Operational highlights: first sensor production run completed in October 2025 in a new CER; pen production began in October with capacity >2x the pens needed for 2026 targets; patch/reader first production run expected in November 2025; overall manufacturing capacity exceeds 2x the units Profusa says are required to meet 2026 revenue targets. Profusa intends distributor partnerships with AngioPro and Dismeval, covering ~35% of European procedures, and cites a 2025 European CLTI market of >700,000 procedures.
Profusa (Nasdaq: PFSA) announced on October 22, 2025 an expansion of commercial distribution for its Lumee Oxygen platform in Europe via a letter of intent with Angiopro GmbH.
Initial target launch markets are Germany, Benelux, Austria, the United Kingdom, and Scandinavia. Combined with a prior Spain distributor, Profusa estimates distributor channels now cover ~35% of the European Union population. The company cites ~300,000 annual endovascular procedures in Europe and a global addressable market of $10.5B+ across three indications: peripheral artery disease, chronic wounds, and critical limb ischemia.