Flow Medical raises seed round for next-gen thrombolysis catheter
Summary
The startup was a runner-up for the 2024 MedTech Innovator accelerator grand prize.Theyve 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. 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.Were eager to be in front of the interventional community and for people to have awareness of our product and what were 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.Were especially proud to have University of Chicago as an investor here. 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 Medicals 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.Fried also shared some technical updates on her companys system and how its designed to work.