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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 really 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. 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. 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. Fried also shared some technical updates on her company’s system and how it’s designed to work. We’ve got more on that from our interview as well as images and video of their system at Medical Design & Outsourcing.

Flow Medical is developing a thrombolysis catheter to improve the treatment of blood clots in pulmonary embolism patients. The Chicago-based startup designed its minimally invasive system with a novel nitinol scaffold that perforates blood clots and infuses them with tissue plasminogen activator (TPA), a thrombolytic drug commonly referred to as a clot-buster. Flow Medical recently offered Medical Design & Outsourcing our first good look at the prototype with some images that we’re sharing here. Flow Medical co-founder and CEO Jennifer Fried has so far declined to dive deep into the technology with us, but she and her team offered some details to us previously and have also commented publicly elsewhere. For example, Fried and co-founders Dr. Jonathan Paul and Dr. Osman Ahmed discussed the system and showed how it works in the video at the end of this post, which they submitted as a finalist for the MedTech Innovator accelerator’s 2024 grand prize. Here’s what we know about the system based on our previous interviews with Fried and other information the company has shared in recent months. The Flow Medical system accesses a patient’s lungs via the femoral artery and through the heart. To help physicians navigate the multi-function catheter to where it’s needed, Flow Medical designed the outer sheath of its catheter for simultaneous high-pressure diagnostics angiography. That outer sheath has holes in it to release dye for visualizing the patient’s vasculature, allowing the physician to locate the clot and place the device inside it with precision and accuracy — and avoiding the need for device swaps between diagnosing the clot and treating it. After the catheter is all the way through the length of the clot, the sheath pulls back to reveal the scaffold. The adjustable catheter allows for different lengths of the scaffold to match the length of the clot. The company engineered the delivery scaffold with hollow nitinol tubing and laser-cut holes specifically for thrombolytic delivery. Nitinol’s super-elasticity allows the scaffold to compress down for catheter delivery and expand inside the patient when the sheath is retracted to disrupt the clot. Flow Medical designed the scaffold to maximize surface contact with the clot as it delivers TPA. The catheter also has a fiber-optic pulmonary artery pressure sensor for real-time hemodynamic monitoring. That’s meant to help physicians determine how much of the clot-busting drug to administer and for how long. When the job is done, the scaffold compresses back down into the catheter as it retracts. The entire process is shown in the video from Flow Medical below.

Innovative, Nature-inspired Mechanism, Dissolving Blood Clots Without Inducing Bleeding, Shows Promises of Enhanced Safety and Efficacy CAMBRIDGE, MA, USA I September 24, 2024 I Thrombolytic Science, LLC (TSI), a private clinical-stage biotech company focused on developing clot-dissolving therapies for thrombotic diseases, announced today that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for mutant prourokinase, a recombinant fibrinolytic pro-enzyme. A U.S.-based clinical trial will further confirm the safety and tolerability of TSI’s novel mutant prourokinase (mproUK) in healthy volunteers. “We are thrilled to achieve this important milestone with the FDA clearance for our first U.S. clinical trial of mproUK,” said Alexis C. Wallace, MSc. Eng., MBA, CEO of TSI. “Our innovative approach to fibrinolytic therapy has the potential to transform the treatment landscape for life-threatening thrombotic conditions, offering patients a faster, safer, and more effective reperfusion option. Following promising Phase II results from the DUMAS trial in stroke patients in the Netherlands, we’re now advancing to a Phase II trial in the UK for myocardial infarction following MHRA approval. This IND clearance is a significant step toward expanding access to our low-dose fibrinolytic treatment for broader patient populations globally.” In the natural, physiological mechanism of clot lysis, while tissue plasminogen activator (tPA) initiates clot lysis, prourokinase completes the dissolution of the fibrin clot. “This difference is comparable to the starter of a car and its engine.  tPA is like the starter, whereas prourokinase is the engine”, explained Victor Gurewich, MD, TSI co-founder and discoverer of prourokinase. “Physiological fibrinolysis requires a mini bolus of r-tPA followed by an infusion of a low dose of mproUK. In recent clinical studies, this treatment has been shown to be free of bleeding risk and rethrombosis while having the potential to re-establish blood flow earlier and being more cost effective than in-hospital surgical solutions.” About mproUK TSI’s treatment is based on the natural, biological clot dissolving mechanism involving the sequence of tPA and prourokinase, the latter having been stabilized by a single site mutation. This mutation has significantly improved the safety of prourokinase without interfering with its biological clot lysing mechanism of action.  A successful proof of concept clinical trial using native prourokinase in heart attack patients, preceded by a mini dose of tPA was previously published, the PATENT trial. More recently, promising results were obtained with mutant proUK in ischemic stroke patients, the DUMAS trial. About Thrombolytic Science (TSI) Thrombolytic Science, LLC, is a privately held biotech company developing a new-generation clot-dissolving therapy for heart attack, ischemic stroke and other thrombotic diseases, based on the groundbreaking research on prourokinase by its scientific co-founders at BIDMC / Harvard Medical School SOURCE: Thrombolytic Science