With strong underlying market demand, European distributor and expert physician customer purchase orders are being received by the Company as its 2026 revenue guidance range increases to $1.5 million - $3 million

BERKELEY, Calif, Feb. 19, 2026 (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 received several purchase orders for the Lumee™ tissue oxygen monitoring system from its growing network of European distributors and expert physician customers. With strong underlying market demand, Profusa increased its internal projections, and is subsequently increasing its revenue guidance range for 2026, to $1.5 million to $3 million compared to a previously announced range of $500 thousand to $2 million.

"Our team is focused on establishing our commercial operations and building out broad European market coverage with distributors and expert physician customers. In the past two months, prominent vascular surgeons presented positive data from clinical studies conducted in the United States at the 2026 Leipzig Interventional Course in Germany and the 2025 Paris Vascular Insights in France. These positive results continue to validate the Lumee Oxygen's clinical value for Chronic Limb Threatening Ischemia (CLTI) treatment. Momentum in the clinical community is increasing. We believe surgeons are anxious to incorporate Lumee Oxygen into their procedures. Surgeons and distributors have issued purchase orders in anticipation of regulatory approval as soon as April 2026. We previously received CE Mark approval under the prior European regulatory framework; however, our ability to fulfill these purchase orders remains contingent upon completion of its migration to comply with the European Union Medical Device Regulation, which the Company currently anticipates finalizing in the second quarter of 2026. Our operations team is already building inventory to support anticipated demand and enable revenue generation early in the second quarter of 2026.

"We believe that with the rapid adoption of the Lumee Oxygen product by surgeons in Europe and our recently announced collaboration with the Mayo Clinic, we are well positioned to potentially enter the US market as soon as late 2026. With additional focus on our Healthcare Research business, we expect revenue to build throughout 2026.

"Given the demand resulting in purchase orders for Lumee Oxygen in Europe and progress we are making in the Healthcare Research business, we have increased our internal revenue projections, and we are raising our revenue guidance range for 2026 to $1.5 million to $3.0 million. We continue to mark our commercial progress and are excited by our growth journey ahead," said Ben Hwang, Ph.D., Profusa's Chairman and CEO.

Profusa intends to provide an update on its European CE Mark approval via GMED under EU Medical Device Regulation (MDR) in 1Q2026, which will catalyze product shipments beginning 2Q2026.

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 including, without limitation, risks related to the timing, receipt, fulfillment, size, or cancellation of purchase orders, the possibility that purchase orders may not be received or may not result in revenue at the levels anticipated, and the risk that customer demand may be less than expected. 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.

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Profusa Receives Purchase Orders for Lumee™ Tissue Oxygen Monitoring and Raises 2026 Revenue Guidance