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

Rhea-AI Summary

Profusa (Nasdaq: PFSA) completed key manufacturing milestones and says it is on track to begin product shipments and generate revenue in early Q2 2026 for its Lumee tissue oxygen monitoring systems.

Operational highlights: first sensor production run completed in October 2025 in a new CER; pen production began in October with capacity >2x the pens needed for 2026 targets; patch/reader first production run expected in November 2025; overall manufacturing capacity exceeds 2x the units Profusa says are required to meet 2026 revenue targets. Profusa intends distributor partnerships with AngioPro and Dismeval, covering ~35% of European procedures, and cites a 2025 European CLTI market of >700,000 procedures.

Positive

• Sensor production run completed in October 2025
• Manufacturing capacity >2x units required for 2026 revenue targets
• Pen production began in October 2025
• Distributor partnerships covering ~35% of European procedures

Negative

• Revenue not yet realized; shipments targeted for early Q2 2026
• Lumee patch/reader production first run still expected in November 2025
• Initial commercial rollout depends on distributor network and rollout execution

Insights

Commercial Manufacturing Analyst

Completed manufacturing build-out and distributor partnerships position Lumee for initial commercial shipments and revenue in early Q2 2026.

Profusa reports completed sensor production in a new CER and the start of pen production, with patch/reader runs expected in November. The company states manufacturing capacity exceeds requirements by more than 2x for sensors, pens, and patch/readers relative to its stated 2026 revenue targets, which should materially reduce short‑term supply risk and support initial fulfillment to distributors.

Key dependencies and risks include timely completion of the patch/reader first run and successful handoff to contracted distributors; those items directly affect the company’s stated plan to deliver inventory to distributors in the first quarter of 2026. The announced distributor reach (~35% of European procedures) and the company’s estimate of >700,000 European CLTI procedures in 2025 provide a tangible near‑term addressable market figure to compare against shipment cadence.

Watch the actual product shipment confirmations, distributor inventory receipts in the first quarter of 2026, and the November production outcome for patch/readers; those events will verify operational execution and the timing of revenue recognition over the following quarters.

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 targets
• Engaged 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 directors in the development of a new generation of tissue-integrated sensors to detect and continuously transmit actionable, medical-grade data for personal and medical use. With its long-lasting, injectable and affordable biosensors and its intelligent data platform, Profusa aims to provide people with a personalized biochemical signature rooted in data that clinicians can trust and rely on.

“LUMEE”, “PROFUSA” and the PROFUSA logo are registered trademarks of Profusa Inc. in the United States, Canada, European Union, China, Japan, South Korea and Australia.

For more information, visit https://profusa.com.

Special Note Regarding Forward-Looking Statements

Certain statements in this press release (this “Press Release”) may be considered “forward-looking statements” within the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements generally relate to future events or future financial or operating performance of Profusa. In some cases, you can identify forward-looking statements by terminology such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “forecast,” “future,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “propose,” “seek,” “should,” “strive,” “will,” or “would” or the negatives of these terms or variations of them or similar terminology. Such forward-looking statements are subject to risks, uncertainties, and other factors which may be beyond the control of Profusa and could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Profusa and its management are inherently uncertain. Profusa cautions you that these statements are based on a combination of facts and factors currently known and projections of the future, which are inherently uncertain. There are risks and uncertainties described in the definitive proxy/final prospectus relating to the business combination, which has been filed with the SEC, and in other documents filed by Profusa from time to time with the SEC. These filings may identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Profusa cannot assure you that the forward-looking statements in this communication will prove to be accurate.

Contacts

Investor and Media Contacts

email:  info@coreir.com
phone:  1 (212) 655-0924

FAQ

When does Profusa (PFSA) expect to begin Lumee product shipments and revenue?

Profusa targets beginning shipments and revenue in the beginning of Q2 2026.

What production milestones did Profusa (PFSA) complete in October 2025?

Profusa completed the first sensor production run in its new CER and began pen production in October 2025.

What is Profusa's stated manufacturing capacity versus 2026 needs for PFSA?

The company states production capacity is more than 2x the units required to achieve its 2026 revenue targets.

Which distributors will Profusa (PFSA) partner with in Europe and what coverage do they provide?

Profusa intends to partner with AngioPro and Dismeval, which together cover about 35% of European procedures.

When is Lumee patch/reader production scheduled to begin for PFSA?

Profusa expects the Lumee patch/reader first production run in November 2025.

How large is the cited 2025 European CLTI market mentioned by Profusa (PFSA)?

Profusa estimates the 2025 European CLTI market comprises more than 700,000 procedures.