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Profusa Launches Lumee™ Tissue Oxygen Healthcare Research Offerings, Initiating First Commercial Revenue

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(High)
Rhea-AI Sentiment
(Positive)
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Profusa (Nasdaq: PFSA) launched the Lumee tissue oxygen Healthcare Research offering on Jan 16, 2026, making research-use-only (RUO) Lumee kits and a service-enabled platform commercially available for immediate deployment to contract research organizations (CROs).

The initiative targets the global CRO market, cited at $47.9 billion in 2025 with a projected ~7% CAGR, and is intended to generate near-term service revenue by enabling continuous, real-time tissue oxygen measurements for preclinical, translational, organ-on-chip, and other R&D applications. Profusa named Sean Givens to lead commercialization as Head of Government and Healthcare Research Business.

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Positive

  • Immediate commercial availability of Lumee RUO kits and services
  • Targets a $47.9B global CRO market (2025) with ~7% CAGR
  • Continuous, real-time tissue oxygen data for preclinical and translational research
  • Commercialization lead appointed (Sean Givens) to scale CRO engagement

Negative

  • Research-use-only (RUO) designation prevents clinical/diagnostic use
  • No quantified revenue guidance or orders disclosed for near-term impact

News Market Reaction – PFSA

+4.06% 2.5x vol
12 alerts
+4.06% News Effect
+55.7% Peak Tracked
-15.2% Trough Tracked
+$332K Valuation Impact
$9M Market Cap
2.5x Rel. Volume

On the day this news was published, PFSA gained 4.06%, reflecting a moderate positive market reaction. Argus tracked a peak move of +55.7% during that session. Argus tracked a trough of -15.2% from its starting point during tracking. Our momentum scanner triggered 12 alerts that day, indicating notable trading interest and price volatility. This price movement added approximately $332K to the company's valuation, bringing the market cap to $9M at that time. Trading volume was elevated at 2.5x the daily average, suggesting notable buying interest.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Global CRO market 2025: $47.9 billion CRO market CAGR: 7% CAGR Global CRO market 2034: over $91.2 billion +1 more
4 metrics
Global CRO market 2025 $47.9 billion Target pharmaceutical CRO market size in 2025
CRO market CAGR 7% CAGR Forecast growth rate for global pharmaceutical CRO market
Global CRO market 2034 over $91.2 billion Forecast global pharmaceutical CRO market by 2034
Industry experience over 20 years Experience of Sean Givens in government accounting and contracting

Market Reality Check

Price: $1.44 Vol: Volume 8,559,825 is 0.16x...
low vol
$1.44 Last Close
Volume Volume 8,559,825 is 0.16x the 20-day average of 54,798,332, indicating subdued trading relative to recent activity. low
Technical Shares at $0.0985 are trading below the $0.36 200-day moving average and remain 95.9% under the 52-week high.

Peers on Argus

PFSA gained 9.2% while key peers were mixed: AIMD down 0.51%, ALUR up 4.42%, oth...

PFSA gained 9.2% while key peers were mixed: AIMD down 0.51%, ALUR up 4.42%, others flat. No coordinated sector momentum or scanner-confirmed peer move was present.

Historical Context

5 past events · Latest: Jan 08 (Positive)
Pattern 5 events
Date Event Sentiment Move Catalyst
Jan 08 Customer adoption news Positive +0.1% Greek vascular surgeon adopting Lumee Oxygen for clinical and home monitoring.
Dec 31 Commercial expansion Positive -14.0% French distribution deal and long-term revenue targets for European rollout.
Dec 30 Financing restructuring Positive +78.3% Convertible note terms revised to raise conversion floor and adjust payments.
Dec 15 Clinical results Positive -19.9% US PAD study met primary endpoints with long-term Lumee oxygen monitoring.
Dec 11 Conference presentation Positive +0.6% Announcement of US Lumee clinical data presentation at LINC 2026.
Pattern Detected

Positive operational and clinical news has produced mixed reactions: some strong rallies on financing changes, but also notable selloffs or muted responses to favorable clinical and commercial updates.

Recent Company History

Over the past few months, Profusa reported several milestones around its Lumee™ platform and capital structure. On Dec 11, 2025, it highlighted upcoming U.S. clinical data at LINC 2026, followed by pilot PAD results meeting primary endpoints on Dec 15, 2025, which saw a -19.87% move. A note restructuring on Dec 30, 2025 coincided with a 78.33% gain. Late December and early January news focused on European distribution and surgeon adoption, with reactions of -13.96% and 0.1%. Today’s announcement adds an initial commercial revenue channel via research-use Lumee offerings.

Market Pulse Summary

This announcement establishes initial commercial research revenue potential as Profusa launches Lume...
Analysis

This announcement establishes initial commercial research revenue potential as Profusa launches Lumee tissue oxygen monitoring into the CRO market, targeting a global space projected at $47.9 billion in 2025 with a 7% CAGR. It complements recent clinical milestones and European distribution developments. Investors may watch uptake by CRO partners, progress toward broader commercialization timelines referenced in prior news, and any further updates on financing structures and going-concern disclosures from recent SEC filings.

Key Terms

contract research organizations, CRO, organ-on-chip, preclinical pharmacology, +3 more
7 terms
contract research organizations technical
"launch ... into the contract research organizations (CRO) market."
Contract research organizations (CROs) are independent service providers that run research, testing and regulatory work for companies developing drugs, medical devices or other health products — think of them as the specialized contractors who manage experiments, patient trials and paperwork that companies outsource. Investors care because CROs play a direct role in how quickly and cheaply products move through testing and approval; delays, cost overruns or regulatory problems at a CRO can affect the timelines and value of the companies that hire them, and in turn the CRO’s own revenue and growth.
CRO technical
"Targets the global CRO market of $47.9 billion in 2025"
CRO stands for Contract Research Organization, a company that helps pharmaceutical and biotech firms manage and carry out clinical trials to test new medicines. For investors, CROs are important because they enable drug companies to develop new treatments more efficiently, potentially accelerating the path to market and affecting the company's growth prospects and success.
organ-on-chip medical
"applications including advanced in vitro and organ-on-chip models"
A small laboratory device that recreates key functions of a human organ on a micro scale by using living cells and tiny channels to mimic blood flow and tissue structure. Like a flight simulator for drugs, it lets developers test safety and effectiveness faster and cheaper than full clinical trials, reducing development risk, time and cost and potentially improving the odds and timing of a product reaching the market—information investors use to value biotech and medical-technology companies.
preclinical pharmacology medical
"preclinical pharmacology and toxicology studies, and translational research"
Preclinical pharmacology is the study of how an experimental drug behaves and affects living systems during laboratory and animal testing before human trials begin. It answers basic questions about how the drug works, how much is needed, and whether it causes harm—like prototype testing of a product in controlled settings. For investors, strong preclinical results reduce technical risk, clarify development costs and timelines, and can materially change a program’s value and likelihood of reaching market.
toxicology medical
"preclinical pharmacology and toxicology studies, and translational research"
Toxicology is the science that studies how chemicals, drugs or other substances can harm people, animals or the environment and determines what exposure levels are safe. For investors, toxicology results act like a safety checklist: they influence whether a product can get regulatory approval, be sold without restrictions, or face recalls and legal risks—factors that can materially affect a company’s prospects and stock value.
tumor microenvironments medical
"tissue oxygenation dynamics in wound healing and tumor microenvironments in oncology"
The tumor microenvironment is the neighborhood around a tumor — the mix of normal cells, immune cells, blood vessels, and support structure that surrounds and interacts with cancer cells. It matters to investors because this environment strongly influences whether therapies will reach and kill tumors, how cancers resist treatment, and which drugs or diagnostics are likely to succeed; understanding it is like knowing local conditions before launching a product.
immunotherapy medical
"predict patient response to immunotherapy regimens."
Treatment that uses or enhances the body’s immune system to detect and fight disease, most often cancers or chronic infections; think of it as training or arming the body’s own soldiers to find and destroy targets. It matters to investors because successful immunotherapies can lead to high-value drug approvals, recurring revenue from long-term treatments, and changes in competitive dynamics, while failures or safety issues in clinical trials can materially affect company valuations.

AI-generated analysis. Not financial advice.

Research-use-only offerings are commercially available, enabling immediate product and service revenue generation

Targets the global CRO market of $47.9 billion in 2025 and growing at 7% CAGR

BERKELEY, Calif, Jan. 16, 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 the launch of its Healthcare Research version of the Lumee tissue oxygen monitoring into the contract research organizations (CRO) market. This strategic step is expected to generate immediate service-based revenue .

This initiative targets a high-growth segment of the pharmaceutical services industry, where demand is accelerating for more predictive, real-time biological data to improve drug development efficiency and decision-making.   Profusa’s Lumee tissue oxygen products are commercially ready and available for immediate deployment, which will allow CRO partners to rapidly incorporate the technology into existing study designs and offer differentiated services to their clients with minimal implementation risk.

The CRO and pharmaceutical services market continues to experience strong growth, driven by increasing R&D investment, regulatory momentum around new approach methodologies (NAMs), and the need to reduce late-stage development risk. Industry forecasts estimate the global pharmaceutical CRO market could expand from approximately $47.9 billion in 2025 to over $91.2 billion by 2034 at a CAGR of more than 7%, underscoring the expanding addressable opportunity for advanced biosensing platforms.

Building on Profusa’s established success with its Lumee oxygen tissue-integrated biosensor technologies, the company will now offer the Lumee tissue oxygen system as commercial research-use-only (RUO) kits and a service-enabled platform for CRO partners. This provides researchers and R&D teams access to continuous, real-time measurement of tissue oxygenation, providing critical insights across a range of applications including advanced in vitro and organ-on-chip models, preclinical pharmacology and toxicology studies, and translational research programs. In addition, the Lumee tissue oxygen system supports research into complex biological processes such as tissue oxygenation dynamics in wound healing and tumor microenvironments in oncology -- areas where oxygen plays a central role in therapeutic response and biological interpretation. By integrating Lumee tissue oxygen into CRO workflows, Profusa enables pharmaceutical customers to access biologically relevant data that extends well beyond traditional endpoint assays.

To help meet the demand from this industry expansion, Profusa has appointed Sean Givens to lead the commercialization efforts as the Head of Government and Healthcare Research Business. “This is a natural and timely extension of Profusa’s platform building off of previous successes of this market,” said Mr. Givens. “Our sensors are validated, ready to ship, and already generating strong interest across the industry. By partnering with CROs, we can help accelerate better drug development decisions while creating a meaningful, near-term revenue stream for Profusa.”

Please contact ruo.sales@profusa.com for additional information about this offering.

Mr. Givens brings over 20 years of government accounting and contracting experience, as well as extensive operations experience in consumer electronics, medical devices and drug development. Most recently, Mr. Givens served as Profusa’s Head, Government Business. Prior, he was co-founder and COO of MIODx, a company focused on immune repertoire profiling to predict patient response to immunotherapy regimens. At MIODx, he played a key role in acquiring the technology, aligning the partnerships and collaboration strategies, and raising venture capital to develop the company and 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. 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

What did Profusa (PFSA) announce on January 16, 2026 about Lumee Tissue Oxygen?

Profusa announced the commercial launch of the Lumee Healthcare Research RUO kits and a service-enabled platform for CROs, available for immediate deployment.

How large is the market Profusa (PFSA) is targeting with the Lumee RUO offering?

Profusa targets the global pharmaceutical CRO market cited at $47.9 billion in 2025 with an expected ~7% CAGR.

Will the Lumee tissue oxygen system be usable in clinical care or diagnostics?

No; the current offering is labeled research-use-only (RUO), so it is not for clinical or diagnostic use.

Does Profusa (PFSA) disclose expected revenue from the Lumee CRO commercialization?

The announcement states the initiative will generate immediate service-based revenue but does not provide quantified revenue guidance or order sizes.

Who will lead Profusa's commercialization for government and healthcare research?

Profusa appointed Sean Givens as Head of Government and Healthcare Research Business to lead commercialization efforts.
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