Flow Medical raises $6M to start human trials of its clot-busting catheter
What's the deal? Chicago-based Flow MedicalDealroom has a profile for this one. Try Dealroom → has raised $6 million to fund the first-in-human trials of its HELYX-PE System, a catheter-directed device for treating pulmonary embolism. The round includes two strategic medical device investors, whom chief executive officer Jennifer Fried declined to name.
Who's backing it? New investors and returning backers joined, including the University of Chicago Medical Center's UCM Ventures. Flow Medical was co-founded by Fried, cardiologist Dr. Jonathan Paul, and physician Dr. Osman Ahmed.
What does it do? HELYX-PE is a 9 French catheter-directed thrombolysis platform that combines an expandable nitinol infusion scaffold, integrated angiography, and continuous pulmonary artery pressure monitoring. The scaffold perforates blood clots and infuses them with clot-dissolving tPA.
Why now? The company froze the device's design this year and expects its first-in-human case "very soon." It plans an investigational device exemption submission in 2027.
What's the money for? The funds will cover the first-in-human evaluation, continued product development and manufacturing, and preparation for a US pivotal study to support an FDA 510(k) submission.
What's the endgame? Fried points to a US market for catheter-based PE interventions estimated at more than $2 billion. She said most eligible patients never get such a procedure and are instead admitted, anticoagulated, and monitored.
The backstory: Flow Medical was a MedTech InnovatorDealroom has a profile for this one. Try Dealroom → grand prize runner-up in October 2024 and raised a $5 million seed round soon after. Fried describes the system as complementary to large-bore thrombectomy, aimed at patients better suited to catheter-directed thrombolysis.
The signal: The raise lands amid steady investor appetite for cardiovascular devices, with peers like StimCardio and Blue Arbor Technologies closing rounds this autumn. Flow Medical is betting it can convert a large, underserved patient pool into a new standard of care.
Read more: bizjournals.com
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