Flow Medical has successfully secured $5 million in an oversubscribed seed financing round, as stated by the thrombolysis catheter innovators today. The round builds on a previously announced $2 million contribution from friends and family, along with new capital from UCM Ventures, the investment arm of the University of Chicago Medical Center.
“We’re extremely enthusiastic to have the necessary capital to engage with a market that is both dynamic and undergoing rapid transformation,” said Jennifer Fried, CEO and co-founder of Flow Medical, during an interview.
Headquartered in Chicago, Flow Medical is in the process of developing an innovative thrombolysis solution for acute pulmonary embolism (PE). The company recently secured runner-up honors in the 2024 MedTech Innovator accelerator.
Their multifunctional catheter is engineered to conduct pulmonary angiograms for the diagnosis and localization of blood clots, then effectively disrupts and dissolves them using a nitinol scaffold that administers tissue plasminogen activator (TPA). It also features an integrated sensor for monitoring pulmonary artery pressure, aiding physicians in customizing the lytic dosage.
According to Fried, approximately 900,000 cases of venous thromboembolism (VTE) occur annually in the U.S., with nearly two-thirds progressing to PE, often originating as deep vein thrombosis clots in the leg that then dislodge and move to the lungs.
“We believe that roughly a third of these patients would greatly benefit from this procedure,” Fried mentioned. “It’s a significant market to target, and it’s notably under-served currently. Presently, only about 15% to 20% of eligible patients in the intermediate risk PE category are receiving therapy.”
The design of their system is now finalized, and they are initiating verification and validation (V&V) testing, Fried explained in an interview. The seed capital will back these ongoing V&V efforts, the start of a first-in-human study, and the building of partnerships to widen adoption and accessibility.
Flow Medical aims for their technology to be used in the first human patient within about a year, Fried revealed.
“We’re enthusiastic about engaging with the interventional community, increasing awareness about our product, its benefits, and what sets it apart,” Fried said. “We’re also considering potential sites and principal investigators — not just for our initial human trial, but for pivotal studies in the future.”
The company has scheduled an FDA Pre-Submission meeting for January to establish the regulatory pathway and timeline, as Fried mentioned.
“We take pride in having the University of Chicago as an investor. It’s their inaugural direct investment in a company like ours, and it’s my second business launched with University of Chicago’s faculty collaborations at the medical center,” said Fried whose previous venture was Explorer Surgical.
Her fellow Flow Medical co-founders include Dr. Jonathan Paul, Chief Scientific Officer, and Dr. Osman Ahmed, Chief Medical Officer, both of whom practice at the University of Chicago Medical Center. Dr. Paul is an interventional cardiologist who has advised on close to 450 PE cases over the last year, while Dr. Ahmed is an interventional radiologist.
“Flow Medical’s technology has great promise in enhancing patient care, and we are thrilled to be part of this endeavor,” expressed Dr. Stephen Weber, Chief Medical Officer for the UChicago Medicine health system, in a statement.
Fried also provided technical insights into their system’s design and functionality, with more details, along with visual representations available at Medical Design & Outsourcing.