PFSAFDA Updates
Profusa Submits Response Package to GMED as Part of Ongoing CE Mark Review Process for Lumee® Oxygen Platform
Profusa, Inc. has submitted a response package to GMED as part of the CE Mark review for its Lumee Oxygen Platform. This submission follows successful assessments of the company's quality system and technical documentation. The Lumee platform aims to provide continuous tissue oxygen monitoring, addressing significant clinical needs. However, the review process remains ongoing with uncertain outcomes.
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Profusa Issues Letter to Shareholders Encouraging Shareholders to Vote FOR All Proposals at June 23, 2026 Annual Meeting
Profusa, Inc. has issued a letter encouraging shareholders to vote in favor of several key proposals at the upcoming Annual Meeting on June 23, 2026. The proposals aim to support the company's Nasdaq listing and facilitate the acquisition of the PanOmics Assay platform. The Board believes these measures are crucial for the company's growth and operational success.
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Profusa Announces Listing Transfer to The Nasdaq Capital Market
Profusa, Inc. has announced its transfer to The Nasdaq Capital Market effective May 15, 2026. This transition is part of a series of milestones set by the Nasdaq Hearings Panel to ensure compliance with listing requirements. The company focuses on developing tissue-integrated sensors for continuous health monitoring.
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Profusa Receives Favorable Nasdaq Listing Determination
Profusa, Inc. has received approval from the Nasdaq Hearings Panel to transfer its listing from The Nasdaq Global Market to The Nasdaq Capital Market. This decision is contingent upon the company's ability to meet specific interim milestones and comply with certain financial requirements by July 6, 2026. Profusa is focused on developing tissue-integrated sensors for continuous biochemical monitoring.
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Profusa Expands into Multi-Billion Dollar Precision Diagnostics Market with $30M Letter of Intent for a PanOmics Platform
Profusa, Inc. has announced a strategic expansion into molecular diagnostics with a $30 million Letter of Intent to acquire the PanOmics platform from BioInsights LLC. This acquisition aims to enhance Profusa's capabilities in precision diagnostics, particularly for pancreatic cancer applications, and is supported by a partnership with Mayo Clinic. The deal is expected to provide a clear pathway to commercialization and significant growth potential.
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Profusa To Withdraw S-1 Registration Statement to Pursue a Smaller, More Focused Offering
Profusa, Inc. has decided to withdraw its S-1 Registration Statement to pursue a smaller offering that aligns better with its operational needs. The company aims to support the projected revenue from its Lumee Oxygen product and its collaboration with the Mayo Clinic. This decision reflects confidence in their recent operational progress and future market entry plans.
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Profusa and Mayo Clinic collaborate to Advance High-Impact Clinical Applications of Oxygen Monitoring Technologies
Profusa has partnered with Mayo Clinic to advance the commercialization of its Lumee wearable oxygen monitoring technology. This collaboration aims to explore high-impact clinical applications, particularly in areas like cardiovascular and orthopedic health. The initiative seeks to improve patient outcomes through continuous monitoring of tissue oxygen levels, addressing unmet clinical needs.
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Profusa Announces 1-for-75 Reverse Stock Split
Profusa, Inc. has announced a 1-for-75 reverse stock split effective February 9, 2026. This consolidation will reduce the number of outstanding shares from approximately 92.4 million to about 1.2 million, while maintaining the par value per share. The move aims to enhance the stock's market perception and streamline trading on Nasdaq.
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Profusa Presents Positive US-Study Clinical Results at Leipzig Interventional Course (LINC) 2026
Profusa, Inc. presented positive results from a US clinical study on its Lumee oxygen monitoring technology for peripheral artery disease (PAD) patients at the Leipzig Interventional Course 2026. The study demonstrated safety and effectiveness, showing a strong correlation with traditional monitoring methods. The company anticipates significant revenue growth from its European operations starting in Q2 2026.
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Profusa Launches Lumee™ Tissue Oxygen Healthcare Research Offerings, Initiating First Commercial Revenue
Profusa, Inc. has launched its Lumee tissue oxygen monitoring system for contract research organizations (CROs), aiming to generate immediate revenue. This initiative targets the expanding CRO market, projected to grow significantly by 2034. The system offers real-time biological data, enhancing drug development processes and decision-making for pharmaceutical partners.
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Profusa Bolsters European Commercial Network with New French Distributor, MedSell
Profusa has announced a new distributor partnership with MedSell to commercialize its Lumee Oxygen tissue monitoring device in France. This collaboration aims to enhance patient care for those with Critical Limb Threatening Ischemia (CLTI) and builds upon existing partnerships across Europe. Profusa anticipates significant revenue growth as it expands its market presence, particularly in the European Union.
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Profusa Restructures Senior Secured Convertible Notes, Only Convertible Above $0.35
Profusa, Inc. has restructured its Senior Secured Convertible Notes to enhance repayment flexibility and reduce shareholder dilution. The conversion floor price has been raised to $0.35, and mandatory amortization payments have been eliminated. This restructuring is part of Profusa's efforts to improve its balance sheet and support future growth initiatives.
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Profusa to Present US-Study Clinical Data at Leipzig Interventional Course (LINC) 2026
Profusa, Inc. will present clinical data from its US study on Lumee technology at the Leipzig Interventional Course (LINC) 2026. The study focuses on tissue oxygen monitoring in patients with peripheral artery disease. The presentation is scheduled for January 28, 2026, and aims to share insights and engage with healthcare professionals.
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