Profusa Hits Key Milestone, Ramps Up Manufacturing for 2026 Revenue
Digital health company Profusa confirms its manufacturing capacity is now more than double what's needed for its 2026 targets, signaling a confident move toward commercialization.
Berkeley-based digital health innovator Profusa (NASDAQ: PFSA) just cleared a major hurdle on its path to commercialization. The company announced it has successfully completed key manufacturing build-outs for its Lumee™ tissue oxygen monitoring system. This critical step puts Profusa firmly on track to begin generating revenue from product shipments in early 2026. This isn’t just a minor update; the company has established a production capacity that is more than double what it projects it will need to hit its 2026 revenue goals.
From Production Line to Profit Line
Profusa’s management team is signaling that the transition from development to sales is imminent. The company’s leadership has laid out a clear and focused timeline for investors. They expect to stock their distributors with inventory during the first quarter of 2026, setting the stage for the first official sales to customers at the start of the second quarter.
Fred Knechtel, Profusa’s CFO, underscored the team’s singular focus on this goal, stating:
“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.”
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Manufacturing Capacity Locked In
The company’s confidence stems from tangible achievements in its production capabilities. Profusa reported that its brand-new CER (Controlled Environment Room) completed its first sensor production run in October. That facility alone can produce more than twice the sensors required for 2026 targets.
Furthermore, Profusa has engaged a contract manufacturer to handle the production of its Lumee patch/readers and pens. This partnership is already bearing fruit. Pen production kicked off in October, again with capacity easily exceeding 2026 projections by more than 200%. The final piece, the Lumee patch/reader, is scheduled for its first production run in November, and it boasts the same impressive 2x capacity surplus. This robust over-capacity strategy effectively de-risks the product launch from potential supply chain bottlenecks.
Responding to Clinical Demand
This manufacturing push is a direct response to positive feedback from the market. The company is gearing up to serve what it identifies as a significant unmet clinical need for advanced tissue oxygen monitoring. Profusa’s leadership sees a clear demand from clinicians and researchers who need better diagnostic tools.
Ben Hwang, Ph.D., Profusa’s Chairman and CEO, commented:
“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.”
This momentum is already translating into a solid commercial foundation, particularly in Europe. Profusa has partnerships with distributors AngioPro and Dismeval, S.L., a strategic move that gives its Lumee system access to approximately 35% of all relevant procedures in the European market. With an estimated 700,000 procedures for Critical Limb Threating Ischemia (CLTI) in Europe in 2025, Profusa has built the factory and secured the partners to chase a significant market opportunity.
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