Profusa Inc Stock Price, News & Analysis

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.

Profusa (Nasdaq: PFSA) expanded its European commercial footprint for the Lumee Oxygen platform by signing a letter of intent with Angiopro on Oct 15, 2025 to establish logistics and commercialization in Germany, Benelux, Austria, the UK, and Scandinavia.

The deal, together with a previously announced Spain distributor, brings distribution coverage to approximately 35% of the EU population. Management cites an estimated $10.5B+ global addressable market across peripheral artery disease, chronic wounds and critical limb ischemia and references ~300,000 annual endovascular procedures in Europe as an initial target opportunity.