Profusa Completes Manufacturing Build-Out, On Track to Begin Product Shipments and Revenue in Early 2026

Core Insights - Profusa has achieved key operational milestones in manufacturing capabilities, enabling the supply of more than 2 times the products required to meet 2026 revenue targets [1][7] - The company is focused on generating revenue from Lumee™ tissue oxygen monitoring systems sales starting in the second quarter of 2026, with inventory expected to be available for distributors in the first quarter of 2026 [2][3] - Profusa's manufacturing initiatives include partnerships with distributors AngioPro and Dismeval, covering approximately 35% of European procedures, and targeting a market of over 700,000 procedures for Critical Limb Threatening Ischemia (CLTI) in Europe for 2025 [3] Manufacturing and Production - The first sensor production run was completed in October in a Controlled Environment Room (CER), with production capacity exceeding 2 times the sensors needed for 2026 revenue targets [7] - A contract manufacturer has been engaged to produce Lumee patch/readers and pens, with pen production beginning in October and capacity also exceeding 2 times the required amount for 2026 [7] - The first production run for Lumee patch/reader manufacturing is expected in November, with similar production capacity exceeding 2 times the required amount for 2026 [7] Company Overview - Profusa is a commercial stage digital health company based in Berkeley, California, focused on developing tissue-integrated sensors for continuous monitoring of biochemistry [4] - The company aims to provide personalized biochemical signatures through long-lasting, injectable, and affordable biosensors, supported by an intelligent data platform [4]