Flow Medical

Flow Medical is a Chicago, Illinois-based medical device company developing a catheter-directed thrombolysis (CDT) system designed specifically for treating acute pulmonary embolism (PE). The company was founded in 2020 by University of Chicago physicians Dr. Jonathan Paul, an interventional cardiologist and director of the pulmonary embolism response team at UChicago Medicine, and Dr. Osmanuddin (Osman) Ahmed, a vascular and interventional radiologist, together with health tech entrepreneur Jennifer Fried, who joined as CEO and co-founder in 2023. Paul serves as chief scientific officer and Ahmed as chief medical officer; both continue to practice at the University of Chicago Medical Center.

The company's device is a steerable, multi-function catheter intended to combine diagnosis, therapy delivery and monitoring in a single system. It performs diagnostic-quality pulmonary angiography to locate clots, deploys an adjustable-length nitinol basket that engages and disrupts the clot while delivering tissue plasminogen activator (tPA) directly into the blockage, and incorporates a sensor that measures pulmonary artery pressure in real time so clinicians can personalize and terminate the lytic dose rather than infusing for a preset interval. The team has targeted an 8 Fr catheter profile, with earlier prototypes in the 10–11 Fr range, and has worked with contract development and manufacturing organization Medical Murray and with Ontogen Medtech co-founder Tyler Panian.

As of December 2024 the company had frozen its system design and begun verification and validation testing, following more than a dozen animal studies and roughly a year of design refinement. It had an FDA Pre-Submission meeting scheduled for January to determine the regulatory pathway, planned an investigational device exemption application in 2025, and aimed for first human use approximately a year out, to be followed by a pivotal study in more than 100 patients.

Founding story

The concept originated in December 2020, when Jonathan Paul and Osman Ahmed — colleagues who had jointly built a venous thrombosis and pulmonary embolism program at the University of Chicago — sat together during the observation period after receiving their first COVID-19 vaccine doses. Both were treating a surge of DVT and PE cases associated with COVID-19 and were dissatisfied with existing devices, which had largely been designed for other purposes such as small-vessel arterial thrombolysis and repurposed for the larger pulmonary arteries. As users of those products, they set out to design their own device and to make catheter-directed thrombolysis a more data-driven procedure with better feedback and control over when to stop drug infusion. Jennifer Fried, whose prior company Explorer Surgical also came out of the University of Chicago, was introduced to the founders by Polsky Science Ventures consulting director and Flow Medical advisor/board member Dr. Steve Gould; after initially exploring an advisory role, she joined as CEO and co-founder in 2023.

Traction

The device has been tested in more than a dozen animal studies and refined over approximately a year of design work. The company had frozen its design and started verification and validation testing as of December 2024, with an FDA Pre-Sub meeting scheduled for January, an IDE application planned for 2025, a first-in-human study targeted for roughly a year later and a subsequent pivotal study in more than 100 patients. It received NIH SBIR funding, was a finalist for the Polsky Center's George Shultz Innovation Fund, participated in Polsky I-Corps and the Compass accelerator, and was a runner-up for the 2024 MedTech Innovator accelerator grand prize. Cumulative disclosed capital includes a $1 million strategic investment from an unnamed medical device manufacturer and a $5 million seed round.

Latest developments

In December 2024 Flow Medical closed an oversubscribed $5 million seed round led by UChicago Medicine's UCM Ventures — that fund's first direct med-tech investment — with participation from Everywhere Ventures and inclusive of $2 million previously raised from friends and family. Proceeds are earmarked for design verification and validation testing, an FDA investigational device exemption filing in 2025, initiation of a first-in-human study, and partnerships intended to support adoption and accessibility.