PFSA

Study conducted at US sites evaluates LumeeTM in peripheral artery disease (PAD) patients BERKELEY, Calif, Jan. 29, 2026 (GLOBE NEWSWIRE) -- Profusa, Inc. (“Profusa” or the “Company”) (Nasdaq: PFSA), a commercial stage digital health company pioneering a next-generation technology platform enabling the continuous monitoring of an individual’s biochemistry, announces the presentation of positive US-study clinical trial results at Leipzig Interventional Course in Leipgzig, Germany on Wednesday, January 28, 2026. The study, conducted at the 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). The presentation, titled, “Monitoring Tissue Oxygen Dynamics with a Novel Implantable Hydrogel Sensor in Patients with Peripheral Arterial Disease,” 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 tcpO₂. Sensors were monitored over 12 months with visits at days 2, 10, 90, 180, and 365. Presented Data Highlights: Lumee oxygen traces strongly correlated with TcpO2 during occlusion-induced oxygen decreases on the arm and foot and during Buerger’s positional maneuver test on the foot. Lumee detected post-occlusion reactive hyperemia in 19% (arm) and 5% (foot) of tests, whereas tcpO₂ showed no hyperemic response Sensors remained functional for up to one year No sensor placement related adverse events were reported “Results of our US-clinical study on PAD continues to be well received by the clinical community, with positive reception at LINC 2026,” said Ben Hwang, Ph.D., Profusa’s Chairman and CEO. “We believe this data presented at a preeminent European clinical conference, in addition to support from a growing network of European KOL and physician customers, bode well for our planned commercial activities in the European Union. We are focused on executing on our commercial strategies and expect to deliver 2026 potential revenue of $0.5 to $2 million, with EU Lumee oxygen revenue commencing in 2Q 2026, and $9 to $13 million potential reve...

Recapitalization reduced net debt to $14 million as of October 31; achieved key milestones to deliver potential 2026 revenue target BERKELEY, Calif, Nov. 19, 2025 (GLOBE NEWSWIRE) -- Profusa, Inc. (“Profusa” or the “Company”) (Nasdaq: PFSA), a commercial stage digital health company pioneering a next-generation technology platform enabling the continuous monitoring of an individual’s biochemistry, announces financial results for the third quarter ended September 30, 2025, and provides business highlights. Ben Hwang, Ph.D., Profusa’s Chairman and CEO, said, “It was an extremely busy four months for the team, and we are proud of our achievements in such a short period of time. In the third quarter, we achieved a significant milestone for the company with the completion of our merger with NorthView Acquisition Corporation. We recapitalized our balance sheet, reducing net debt from $34 million to $14 million as of October 31, 2025. Since the closing of the merger on July 11, 2025, we have raised $7 million in gross proceeds through our Equity Line of Credit (“ELOC”) transaction and an additional $2 million in convertible debt. “We also delivered key operational milestones including the build-out of our manufacturing capabilities; entered several potential distributor and clinical and commercial collaborations; and built a team focused on executing the company’s strategy. “We now lead Profusa forward as we execute on our plans to potentially achieve $200 to $250 million in revenue by 2030; capitalize on the near-term European and US Lumee oxygen opportunity to deliver 2026 potential revenue of $0.5 to $2 million and $9 to $13 million potential revenue in 2027,” concluded Mr. Hwang. Third Quarter 2025 Business Highlights: Completed reverse recapitalization with NorthView Acquisition Corporation; Profusa company equity value was $155 million Completed manufacturing build-out and remain on track to begin product shipments and revenue in early 2026 Expanded sales footprint with key distributors for Lumee™ Oxygen tissue monitoring platform in Europe, currently covering approximately 35% of the European population Entered into several clinical and commercial collaborations with vascular surgeons of prominent vascular centers Fred Knechtel, CFO of Profusa, commented, “To deliver value to shareholders and provide the company with adequate capital to achieve near-term rev...