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Flow Medical, a Chicago-based startup developing the investigational HELYX-PE System for pulmonary embolism (PE), has raised $6 million in a round that includes two strategic medical device investors. CEO Jennifer Fried declined to name them. New investors and returning backers, including the University of Chicago Medical Center’s UCM Ventures, also participated.
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HELYX-PE is a 9 French catheter-directed thrombolysis platform combining an expandable nitinol infusion scaffold, integrated angiography, and continuous pulmonary artery pressure monitoring. The scaffold is designed to perforate blood clots and infuse them with tPA. The company froze its design this year, expects a first-in-human case “very soon,” and plans an IDE submission in 2027. The new funds will cover that first-in-human evaluation, continued product development and manufacturing, and preparation for a U.S. pivotal study supporting an FDA 510(k) submission.
Fried points to a market estimated at more than $2 billion in the U.S. for catheter-based PE interventions. She said the vast majority of eligible patients do not receive such a procedure and are instead admitted, anticoagulated, and monitored. She also described the system as complementary to large-bore thrombectomy, aimed at patients better suited to catheter-directed thrombolysis.
Flow Medical was a MedTech Innovator grand prize runner-up in October 2024 and raised a $5 million seed round soon after. The company was co-founded by Fried, Dr. Jonathan Paul, and Dr. Osman Ahmed.
