Profusa completes manufacturing build-out for early 2026 product launch

Profusa Inc. (NASDAQ: PFSA) announced the completion of manufacturing initiatives to support revenue targets for its Lumee tissue oxygen monitoring systems, with product shipments expected to begin in early 2026.

The Berkeley-based digital health company completed its first sensor production run in October at its newly constructed Controlled Environment Room. The company stated its production capacity exceeds twice the sensors required to achieve 2026 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," said Fred Knechtel, Profusa's CFO. The company plans to provide inventory to distributors in the first quarter of 2026.

Profusa engaged a contract manufacturer to produce Lumee patch/readers and pens. Pen production began in October with capacity exceeding twice the requirement for 2026 targets. The first production run for Lumee patch/readers is expected in November, also with capacity more than double the required amount.

The company previously announced partnerships with distributors AngioPro and Dismeval, S.L, covering approximately 35% of European procedures. Profusa estimates the 2025 European Critical Limb Threatening Ischemia market comprises more than 700,000 procedures.

Profusa develops tissue-integrated sensors that detect and transmit medical-grade data for clinical use. The company's Lumee system provides continuous tissue oxygen monitoring through injectable biosensors.

The information is based on a company press release statement.

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