Business
Profusa Completes Manufacturing Build-Out, On Track to Begin Product Shipments and Revenue in Early 2026
Achieved key operational milestones establishing manufacturing capabilities to supply more than 2x the products required to achieve 2026 revenue targets
About this update from Profusa, Inc.
[{"type":"text","content":"Achieved key operational milestones establishing manufacturing capabilities to supply more than 2x the products required to achieve 2026 revenue targets BERKELEY, Calif, Oct. 28, 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 completion of key manufacturing initiatives to support 2026 Lumee™ tissue oxygen monitoring revenue targets. “Our team is laser-focused on achieving revenue from sales of Lumee™ tissue oxygen monitoring systems to our customers in the beginning of the second quarter of 2026. Our manufacturing and supply chain projects are on track to provide inventory to our distributors in the first quarter of 2026 to support 2026 revenue projections,” said Fred Knechtel, Profusa’s CFO. “We are driven by the positive momentum received from our distributors and growing network of clinical and research customers and look forward to serving the unmet clinical need for tissue oxygen monitoring with our innovative Lumee technology platform,” added Ben Hwang, Ph.D., Profusa’s Chairman and CEO. Manufacturing milestones achieved to-date include: Completed first sensor production run in its recently constructed CER (Controlled Environment Room) in October. Production capacity is more than 2x the sensors required to achieve 2026 revenue targetsEngaged contract manufacturer to produce Lumee patch/readers and pens. Pen production began in October and capacity is more than 2x the pens required to achieve 2026 revenue targets Lumee patch/reader manufacturing first production run is expected in November. Production capacity is more than 2x the patch/readers required to achieve 2026 revenue targets As previously announced, Profusa intends to partner with distributors AngioPro and Dismeval, S.L, which covers ~35% of European procedures, and confirmed initial 3 key opinion leader commercial and clinical collaborations. Profusa estimates the 2025 European CLTI (Critical Limb Threating Ischemia) market is comprised of more than 700,000 procedures. 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 direct...