Flow Medical has closed a $5 million oversubscribed seed round, the thrombolysis catheter developer announced. The round includes a previously reported $2 million from friends and family. plus new funding from the University of Chicago Medical Center’s UCM Ventures.
“We’re tremendously excited to have the fuel to be able to go after this market, which is really dynamic and changing very quickly,” Flow Medical co-founder and CEO Jennifer Fried said in an interview.
Chicago-based Flow Medical is developing a new thrombolysis system for treating acute pulmonary embolism (PE). The startup was a runner-up for the 2024 MedTech Innovator accelerator grand prize.
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They’ve designed their multi-function catheter to perform pulmonary angiograms to diagnose and locate blood clots, then disrupt and dissolve it with an expanding nitinol scaffold that delivers tissue plasminogen activator (TPA), while a built-in sensor measures pulmonary artery pressure to help physicians personalize the lytic dose.
There are around 900,000 venous thromboembolism (VTE) cases every year in the U.S., around two-thirds of those will turn into PE, Fried said. Most start as deep vein thrombosis clots in the leg before breaking off and traveling to the lungs.
“We think upwards of a third of those patients are really good candidates for this type of procedure,” Fried said. “It’s a big market to go after, and one that is really under penetrated today. Right now, of the patients who are eligible for endovascular intervention — which is generally the intermediate risk PE market — only about 15% to 20% of those patients are actually receiving therapy.”
They’ve frozen their system design and are just starting verification and validation (V&V) testing, she said in an interview. The seed funding will support those V&V efforts, along with the initiation of a first-in-human study and establishment of “partnerships to ensure broad adoption and accessibility.”
The company hopes to have its technology used on a human patient for the first time about a year from now, Fried said.
“We’re eager to be in front of the interventional community and for people to have awareness of our product and what we’re doing and what differentiates us,” she said. “And thinking about who the right sites and (principal investigators) are going to be — not for our first-in-human, but for our pivotal down the road.”
The company has an FDA Pre-Sub meeting scheduled for January to help determine the appropriate regulatory pathway and timing, Fried said.
“We’re especially proud to have University of Chicago as an investor here. This is the first time they’ve made a direct investment in a company like ours, and this is my second company that I built out of University of Chicago, partnering with faculty at the medical center,” said Fried, whose previous venture was Explorer Surgical.
Her Flow Medical co-founders are Chief Scientific Officer Dr. Jonathan Paul and and Chief Medical Officer Dr. Osman Ahmed, who both practice medicine at the University of Chicago Medical Center. Ahmed is an interventional radiologist, while Paul is an interventional cardiologist who has consulted on about 450 PE cases in the past 12 months.
“We see great potential for Flow Medical’s technology to enhance patient care and are excited to be part of this journey,” Dr. Stephen Weber, chief medical officer for the UChicago Medicine health system, said in a statement.
