Profusa Submits Response Package to GMED as Part of Ongoing CE Mark Review Process for Lumee® Oxygen Platform

Profusa has submitted a comprehensive response package to its European Notified Body GMED following successful completion of Stage 1 and Stage 2 assessments for CE Mark certification of its Lumee Oxygen Platform. The submission includes updates to technical documentation, quality system evidence, clinical evaluation activities, and validation information. The company remains committed to obtaining CE Mark certification to support European commercialization of its tissue oxygen monitoring technology.

06/12/2026, 8:00 AM • GlobeNewswire

Profusa Receives Favorable Nasdaq Listing Determination

Profusa, Inc. (PFSA) has been granted approval by the Nasdaq Hearings Panel to transfer its listing from The Nasdaq Global Market to The Nasdaq Capital Market. The company must satisfy interim milestones and comply with bid price and stockholders' equity requirements by July 6, 2026, to maintain its continued listing.

05/08/2026, 6:00 AM • GlobeNewswire

What's Going On With Profusa Stock Tuesday?

Profusa (NASDAQ: PFSA) shares plummeted 40.27% on Tuesday following the announcement of a Letter of Intent to acquire BioInsights' PanOmics multi-omics diagnostics platform for approximately $30 million in an all-equity deal. The acquisition marks Profusa's strategic expansion into molecular diagnostics and aims to complement its Lumee real-time biochemistry monitoring system, with initial commercialization targeting pancreatic cancer.

04/07/2026, 11:01 AM • Benzinga

Profusa Stock Soars On Deal Targeting Multi Billion Precision Diagnostics Space

Profusa announced an all-equity acquisition of BioInsights LLC's PanOmics multi-omics diagnostics platform, expanding into precision diagnostics. The deal adds $30 million to shareholder equity and accelerates commercialization through integration with Profusa's Lumee platform. The company is also advancing a Mayo Clinic collaboration for pancreatic cancer applications. Profusa shares surged 134.99% in premarket trading.

04/06/2026, 7:58 AM • Benzinga

Profusa Bolsters European Commercial Network with New French Distributor, MedSell

Profusa announced a new distributor partnership with MedSell in France to commercialize its Lumee Oxygen tissue monitoring device for critical limb threatening ischemia (CLTI) patients. This partnership, combined with existing distributors across Europe, now covers approximately 200,000 annual CLI cases in the EU. The company projects $0.5-$2 million revenue in 2026 and $9-$13 million in 2027, with plans to reach $200-$250 million by 2030.

12/31/2025, 7:30 AM • GlobeNewswire

Profusa Announces Third Quarter Business and Financial Highlights

Profusa completed a merger with NorthView Acquisition Corporation, reduced net debt to $14 million, and is preparing to launch its Lumee Oxygen tissue monitoring platform in Europe in early 2026, with potential revenue targets of $0.5-$2 million in 2026 and $9-$13 million in 2027.

11/19/2025, 5:44 PM • GlobeNewswire

Profusa Announces $100 Million Equity Line of Credit to Initiate Bitcoin Treasury Strategy

Profusa, a digital health company, is initiating a Bitcoin treasury strategy by executing a Securities Purchase Agreement with Ascent Partners Fund LLC to purchase up to $100 million in common stock, with proceeds intended to be used for Bitcoin acquisition.

07/21/2025, 8:00 AM • GlobeNewswire