Profusa Expands Sales Footprint with New Distributor for Lumee™ Oxygen Platform in Europe

Rhea-AI Summary

Profusa (Nasdaq: PFSA) expanded its European commercial footprint for the Lumee Oxygen platform by signing a letter of intent with Angiopro on Oct 15, 2025 to establish logistics and commercialization in Germany, Benelux, Austria, the UK, and Scandinavia.

The deal, together with a previously announced Spain distributor, brings distribution coverage to approximately 35% of the EU population. Management cites an estimated $10.5B+ global addressable market across peripheral artery disease, chronic wounds and critical limb ischemia and references ~300,000 annual endovascular procedures in Europe as an initial target opportunity.

Positive

• LOI signed with Angiopro on Oct 15, 2025
• Distribution now covers ~35% of EU population
• $10.5B+ estimated addressable market
• Targets ~300,000 annual endovascular procedures in Europe

Negative

• Agreement is a letter of intent, not a finalized binding distribution contract

Insights

Market Access Strategist

Profusa expands EU distribution with Angiopro to cover ~35% of the EU population; commercialization initially targets major Western and Northern markets.

Profusa and Angiopro will build logistics and commercialization for the Lumee Oxygen platform across Germany, the Benelux countries, Austria, the United Kingdom, and Scandinavia following a letter of intent dated October 15, 2025. The deal increases Profusa’s channel reach to approximately 35% of the European Union population and references roughly 300,000 annual endovascular procedures in Europe as an initial addressable procedural base.

The business mechanism is straightforward: leverage a regional MedTech distributor with regulatory and clinical-sales infrastructure to accelerate market entry and clinician access. This reduces Profusa’s upfront commercial infrastructure needs but leaves revenue outcomes tied to successful local launches, reimbursement uptake, and conversion of procedural opportunity into device usage.

Key dependencies and risks include execution of final commercial agreements, local regulatory and reimbursement acceptance in each target market, and Angiopro’s ability to convert its clinical networks into sustained sales. The release does not disclose pricing, contract length, or sales targets, so near-term commercial impact remains unquantified.

Watch for three concrete signals over the next 6–18 months: signed distribution agreements and territory rights, local regulatory/market authorizations or reimbursement decisions in the named countries, and initial sales or pilot program metrics tied to the ~300,000 annual procedures cited. The $10.5B global addressable market figure frames long‑term potential but does not change immediate execution risk.

Initial target markets for commercialization include Germany, the Benelux countries, Austria, the United Kingdom, and Scandinavia

Expands distributor channel coverage to ~35% of European Union population with ~300,000 annual endovascular procedures

BERKELEY, Calif, Oct. 15, 2025 (GLOBE NEWSWIRE) -- Profusa, Inc. (“Profusa” or the “Company”) (Nasdaq: PFSA), a commercial stage digital health company pioneering the next generation of technology platform enabling the continuous monitoring of an individual’s biochemistry, announces it has expanded its commercial footprint for its Lumee Oxygen platform in Europe with the signing of a letter of intent to establish logistics and commercialization footprint with Angiopro GmbH (“Angiopro”).  Initial markets targeted for launch and commercialization of the Lumee platform include Germany, the Benelux countries, Austria, the United Kingdom, and Scandinavia.  The arrangement with AngioPro builds upon Profusa’s distributor sales coverage in Europe.  Combined with the Company’s previously announced distributor partner in Spain, Profusa now has approximately 35% of European Union population covered through its distribution channels.

“As industry specialists on clinical needs in vascular and peripheral diseases, we recognize the innovation and need for Profusa’s Lumee platform technology. We are also enthusiastic about collaborating with Profusa on additional pipeline clinical indications, such as diabetes and other chronic conditions where continuous tissue monitoring could provide significant patient benefits,” said Benjamin J. Rieck, CEO and General Manager of Angiopro.  “Leveraging our marketing and sales infrastructure, established networks, regulatory expertise, and strong presence in European regions, we are excited to build a strong foundation for long term partnership and growth with Profusa.”

Angiopro is a specialized MedTech distributor and importer dedicated to bringing cutting-edge cardiovascular technologies that enhance patient care to market, driving commercial success.   Angiopro’s industry expertise spans high quality technologies in interventional cardiology, vascular surgery and healthcare IT, with regulatory proficiency and an experienced clinical sales infrastructure calling on an extensive network across Europe.

"With growth capital in hand, we are focused on building our robust distribution infrastructure in Europe and are excited to partner with Angiopro as we execute on our strategy to bring our pioneering real-time personal healthcare technologies to the clinical community, driving growth in our business,” said Ben Hwang, Ph.D., Profusa’s Chairman and CEO.  “With an estimated $10.5B+ global addressable market for our tissue oxygen technology across three indications, including peripheral artery disease, chronic wounds, and critical limb ischemia, including approximately 300,000 annual endovascular procedures in Europe, Profusa is well-positioned to address this large market need with our differentiated Lumee platform technology.”

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 or the combined company. 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, including risks regarding the highly volatile nature of the price of Bitcoin and other cryptocurrencies, as well as the risk that the Company's stock price may be highly correlated to the price of the digital assets that it holds. 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 described 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.

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FAQ

What did Profusa (PFSA) announce on October 15, 2025 about European distribution?

Profusa signed a letter of intent with Angiopro to establish logistics and commercialization for Lumee in Germany, Benelux, Austria, the UK, and Scandinavia.

How much of the European Union population does Profusa (PFSA) cover after the Angiopro LOI?

Combined with an earlier Spain distributor, Profusa now covers approximately 35% of the EU population through its distribution channels.

What market opportunity did Profusa cite for the Lumee Oxygen platform (PFSA)?

Profusa cited an estimated $10.5B+ global addressable market across peripheral artery disease, chronic wounds, and critical limb ischemia.

What clinical procedure volume in Europe did Profusa reference as an initial target for Lumee (PFSA)?

The company referenced approximately 300,000 annual endovascular procedures in Europe as an initial target opportunity.

Which countries are the initial target markets for Profusa's (PFSA) Lumee launch in Europe?

Initial target markets are Germany, the Benelux countries, Austria, the United Kingdom, and Scandinavia.