Profusa Finishes Manufacturing Expansion, Set to Start Product Shipments and Generate Revenue by Early 2026
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Oct 28 2025
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Should l Buy PFSA?
Source: Newsfilter
Manufacturing Milestones: Profusa has achieved significant manufacturing milestones, including the completion of its first sensor production run and the engagement of a contract manufacturer for Lumee patch/readers and pens, with production capacities exceeding twice the requirements for 2026 revenue targets.
Revenue Goals: The company aims to begin generating revenue from Lumee™ tissue oxygen monitoring systems in the second quarter of 2026, with inventory expected to be available for distributors by the first quarter of 2026.
Market Potential: Profusa is partnering with distributors covering approximately 35% of European procedures and estimates the 2025 European market for Critical Limb Threatening Ischemia (CLTI) to involve over 700,000 procedures.
Company Overview: Based in Berkeley, California, Profusa focuses on developing tissue-integrated sensors for continuous biochemical monitoring, aiming to provide reliable medical-grade data for personal and clinical use.
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Analyst Views on PFSA
About PFSA
Profusa, Inc. is a commercial stage digital health company. The Company is engaged in the development of a new generation of biointegrated sensors that potentially empower the individual with the ability to monitor their body chemistry. The Company’s technology enables the development of bioengineered sensors that are designed to become one with the body to detect and continuously transmit actionable, clinical-grade data for personal and medical use. Its first clinical offering in the European Union, the Lumee Oxygen Platform, is designed to report reliable tissue oxygen levels in various regions of interest, both acutely and long-term. The Lumee Oxygen Platform has been designed for use in applications where monitoring of compromised tissue is beneficial, such as peripheral artery disease that results in narrowing of blood vessels and reduced blood flow to the lower limbs; chronic wounds (diabetic ulcers, pressure sores) that do not heal properly; and reconstructive surgery.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Profusa and Mayo Clinic Partner to Enhance Clinical Uses of Oxygen Monitoring Technologies
Collaboration for Advancement: Profusa and Mayo Clinic are partnering to enhance clinical applications of oxygen monitoring technologies.
Focus on High-Impact Solutions: The collaboration aims to develop innovative solutions that can significantly improve patient care and outcomes through advanced monitoring techniques.
See More
Profusa Inc. Launches Lumee Oxygen Monitoring System, Stock Rises 20.3%
- Significant Market Potential: Profusa's Lumee tissue oxygen monitoring system targets a market projected to grow from approximately $47.9 billion in 2025 to over $91.2 billion by 2034, with a CAGR exceeding 7%, indicating strong demand and future growth opportunities.
- Commercialization Progress: The system is now commercially available to contract research organizations (CROs), expected to generate immediate service-based revenue while enhancing drug development efficiency through real-time biological data, strengthening the company's competitive position in the biotech sector.
- Low Implementation Risk: Offered as research-use-only kits, the Lumee system allows CRO partners to easily integrate the technology into existing study designs, minimizing implementation risks and providing researchers with continuous tissue oxygenation measurements for various applications.
- Strengthened Leadership Team: Profusa appointed Sean Givens to lead commercialization efforts, emphasizing strong industry interest in their validated sensors, reflecting the company's recognition in the market and confidence in future growth.
See More
Profusa, Inc. Launches Lumee Biosensor, Initiating First Commercial Revenue
- Product Launch: Profusa has launched the Lumee tissue oxygen monitoring platform, marking the company's first commercial revenue and addressing the demand in the global contract research organization market, projected to reach $47.9 billion by 2025 with a 7% CAGR.
- Technological Innovation: The Lumee platform enables continuous measurement of tissue oxygen levels using an injectable biosensor and optical reader, overcoming the limitations of traditional intermittent or invasive assessment methods, thus providing real-time oxygen data for clinical and research decision-making.
- Market Opportunity: The launch not only opens new revenue streams for Profusa but also supports clinical applications in areas such as chronic wounds and peripheral artery disease, further advancing the integration of biosensors into routine clinical and research use.
- Stock Performance: PFSA shares are currently trading at $0.11, up 14.21%, fluctuating between $0.06 and $5.50, reflecting positive market sentiment towards the company's new product offerings.
See More
Profusa Launches Lumee Monitoring System Targeting $47.9 Billion CRO Market
- Market Opportunity: Profusa's launch of the Lumee tissue oxygen monitoring system is strategically aimed at the contract research organization (CRO) market, expected to generate immediate service revenue in a $47.9 billion global market, addressing the demand for real-time biological data.
- Technical Advantage: The Lumee products are commercially ready for rapid integration into existing study designs, minimizing implementation risks and enabling CRO partners to offer differentiated services, thereby enhancing client satisfaction.
- Industry Growth: The global pharmaceutical CRO market is projected to expand from approximately $47.9 billion in 2025 to over $91.2 billion by 2034, with a CAGR exceeding 7%, highlighting strong demand for advanced biosensing platforms.
- Leadership Change: Profusa has appointed Sean Givens as Head of Government and Healthcare Research Business, leveraging his 20 years of industry experience to drive commercialization efforts aimed at accelerating drug development decisions and creating a near-term revenue stream.
See More
FuelCell Energy Files for $200 Million Stock Offering, Shares Drop 8.9%
- Stock Offering: FuelCell Energy announced an amended sales agreement to increase the total amount of shares available for sale to $200 million, which led to an 8.9% drop in share price to $7.23 on Wednesday, indicating a negative market reaction to the dilution of shares.
- Market Reaction: The announcement of the stock offering raised investor concerns, as the significant drop in share price could impact the company's future fundraising capabilities and market confidence, particularly in the current economic climate where investors are sensitive to equity dilution.
- Funding Purpose: FuelCell Energy plans to use the proceeds from this offering to support its R&D and operational expenditures, and while the stock faces short-term pressure, successful fundraising could provide the necessary capital to drive technological innovation and market expansion in the long run.
- Industry Impact: In the context of increasing competition in the hydrogen and fuel cell industry, FuelCell Energy's stock offering may affect its reputation among investors, especially as the effectiveness of its financing strategy will directly influence its market position compared to other competitors.
See More
MedSell Commercializes Lumee™ Oxygen Monitoring in France, Reaching 200,000 CLI Cases Annually
- Market Expansion: MedSell partners with Profusa to commercialize Lumee™ oxygen monitoring in France, aiming to cover approximately 200,000 CLI cases annually, significantly enhancing market penetration and influence in Europe.
- Clinical Collaboration: Collaboration with the Vascular Center at Groupe Hospitalier Paris Saint Joseph sees KOL adopting Lumee technology, advancing clinical studies that are expected to enhance the device's value in clinical decision-making for 8% of CLTI cases in France.
- Revenue Projections: Profusa anticipates achieving $200 to $250 million in revenue by 2030, with plans to commercialize in Europe starting in Q2 2026 and expand to the U.S. market, indicating strong growth potential.
- Technology Validation: Lumee oxygen monitoring technology has gained recognition in the European clinical community, with recent presentations of U.S. clinical trial data at conferences in Paris and Leipzig, boosting market confidence and product acceptance.
See More
Profusa and Mayo Clinic Partner to Enhance Clinical Uses of Oxygen Monitoring Technologies
Collaboration for Advancement: Profusa and Mayo Clinic are partnering to enhance clinical applications of oxygen monitoring technologies.
Focus on High-Impact Solutions: The collaboration aims to develop innovative solutions that can significantly improve patient care and outcomes through advanced monitoring techniques.
See More
Profusa Inc. Launches Lumee Oxygen Monitoring System, Stock Rises 20.3%
- Significant Market Potential: Profusa's Lumee tissue oxygen monitoring system targets a market projected to grow from approximately $47.9 billion in 2025 to over $91.2 billion by 2034, with a CAGR exceeding 7%, indicating strong demand and future growth opportunities.
- Commercialization Progress: The system is now commercially available to contract research organizations (CROs), expected to generate immediate service-based revenue while enhancing drug development efficiency through real-time biological data, strengthening the company's competitive position in the biotech sector.
- Low Implementation Risk: Offered as research-use-only kits, the Lumee system allows CRO partners to easily integrate the technology into existing study designs, minimizing implementation risks and providing researchers with continuous tissue oxygenation measurements for various applications.
- Strengthened Leadership Team: Profusa appointed Sean Givens to lead commercialization efforts, emphasizing strong industry interest in their validated sensors, reflecting the company's recognition in the market and confidence in future growth.
See More
Profusa, Inc. Launches Lumee Biosensor, Initiating First Commercial Revenue
- Product Launch: Profusa has launched the Lumee tissue oxygen monitoring platform, marking the company's first commercial revenue and addressing the demand in the global contract research organization market, projected to reach $47.9 billion by 2025 with a 7% CAGR.
- Technological Innovation: The Lumee platform enables continuous measurement of tissue oxygen levels using an injectable biosensor and optical reader, overcoming the limitations of traditional intermittent or invasive assessment methods, thus providing real-time oxygen data for clinical and research decision-making.
- Market Opportunity: The launch not only opens new revenue streams for Profusa but also supports clinical applications in areas such as chronic wounds and peripheral artery disease, further advancing the integration of biosensors into routine clinical and research use.
- Stock Performance: PFSA shares are currently trading at $0.11, up 14.21%, fluctuating between $0.06 and $5.50, reflecting positive market sentiment towards the company's new product offerings.
See More
Profusa Launches Lumee Monitoring System Targeting $47.9 Billion CRO Market
- Market Opportunity: Profusa's launch of the Lumee tissue oxygen monitoring system is strategically aimed at the contract research organization (CRO) market, expected to generate immediate service revenue in a $47.9 billion global market, addressing the demand for real-time biological data.
- Technical Advantage: The Lumee products are commercially ready for rapid integration into existing study designs, minimizing implementation risks and enabling CRO partners to offer differentiated services, thereby enhancing client satisfaction.
- Industry Growth: The global pharmaceutical CRO market is projected to expand from approximately $47.9 billion in 2025 to over $91.2 billion by 2034, with a CAGR exceeding 7%, highlighting strong demand for advanced biosensing platforms.
- Leadership Change: Profusa has appointed Sean Givens as Head of Government and Healthcare Research Business, leveraging his 20 years of industry experience to drive commercialization efforts aimed at accelerating drug development decisions and creating a near-term revenue stream.
See More
FuelCell Energy Files for $200 Million Stock Offering, Shares Drop 8.9%
- Stock Offering: FuelCell Energy announced an amended sales agreement to increase the total amount of shares available for sale to $200 million, which led to an 8.9% drop in share price to $7.23 on Wednesday, indicating a negative market reaction to the dilution of shares.
- Market Reaction: The announcement of the stock offering raised investor concerns, as the significant drop in share price could impact the company's future fundraising capabilities and market confidence, particularly in the current economic climate where investors are sensitive to equity dilution.
- Funding Purpose: FuelCell Energy plans to use the proceeds from this offering to support its R&D and operational expenditures, and while the stock faces short-term pressure, successful fundraising could provide the necessary capital to drive technological innovation and market expansion in the long run.
- Industry Impact: In the context of increasing competition in the hydrogen and fuel cell industry, FuelCell Energy's stock offering may affect its reputation among investors, especially as the effectiveness of its financing strategy will directly influence its market position compared to other competitors.
See More
MedSell Commercializes Lumee™ Oxygen Monitoring in France, Reaching 200,000 CLI Cases Annually
- Market Expansion: MedSell partners with Profusa to commercialize Lumee™ oxygen monitoring in France, aiming to cover approximately 200,000 CLI cases annually, significantly enhancing market penetration and influence in Europe.
- Clinical Collaboration: Collaboration with the Vascular Center at Groupe Hospitalier Paris Saint Joseph sees KOL adopting Lumee technology, advancing clinical studies that are expected to enhance the device's value in clinical decision-making for 8% of CLTI cases in France.
- Revenue Projections: Profusa anticipates achieving $200 to $250 million in revenue by 2030, with plans to commercialize in Europe starting in Q2 2026 and expand to the U.S. market, indicating strong growth potential.
- Technology Validation: Lumee oxygen monitoring technology has gained recognition in the European clinical community, with recent presentations of U.S. clinical trial data at conferences in Paris and Leipzig, boosting market confidence and product acceptance.
See More
