Under the direction of CEO and Co-Founder Jennifer Fried, Flow Medical is creating the new standard of care for interventional pulmonary embolism (PE) treatment. The company is developing the next generation of thrombolysis catheters to address shortcomings of current devices, such as imprecise lytic dosing and lack of access to small distal vessels.
Flow Medical originated in the heart of the University of Chicago’s Medical Center. The company’s innovators were Dr. Jonathan Paul, an interventional cardiologist, and Dr. Osman Ahmed, an interventional radiologist, who joined forces to lead the university’s venous thromboembolism (VTE) program. Their collaboration stemmed from their recognition that their two specialties were uniquely positioned to handle these procedures together, frequently scrubbing into each other’s cases. Fried explained, “It’s a unique type of procedure where half the time it’s being done by interventional cardiologists and the other half by interventional radiologists.”
The turning point came in 2020 with the onset of the COVID-19 pandemic, which led to a surge in pulmonary complications and an increase in PE cases. Paul and Ahmed noticed that despite advancements in large-bore thrombectomy (LBT) devices, many patients, particularly those with clots in the distal vasculature, weren’t benefiting from these innovations. Fried recalled, “We had all these new devices coming forward, but we actually see more patients benefit from catheter-directed thrombolysis (CDT) because many of the clots are in the more distal vasculature, and we can’t access those with large-bore devices.”
Seeing a significant gap in treatment, they decided to “create a next-generation thrombolysis catheter.” After navigating the university’s tech transfer process and partnering with a local engineering group, Flow Medical was born, driven by the goal of creating more effective, targeted solutions for PE patients.
600,000 VTE events occur in the United States. VTE ranks as the third largest cardiovascular killer and is the leading cause of in-hospital mortality.
Fried explained, “Despite this being a major public health problem—and there being great reimbursement—we have not seen a change in the most important metric for these PE patients: mortality, which has hovered at 15% for the last 20 years.” This stagnation in patient outcomes suggests a significant treatment gap despite growing procedure volumes.
One of the primary issues lies in the treatment landscape. Fried continued, “When you look at markets like myocardial infarction, 90% of patients who are eligible for advanced therapies go into the lab and receive intervention. For PE patients, it’s less than 15%.”
The risk stratification of PE patients today places them into three primary treatment categories based on risk levels: anticoagulation alone, catheter-based therapies, and systemic thrombolysis. In the intermediate- to high-risk group, there are two choices for catheter-based therapies: CDT and LBT.
Within this treatment group, many patients will have thrombus in both the large proximal vessels as well as the small distal vessels. Unfortunately, thrombectomy is only able to address the large proximal vessels. On the other hand, there’s CDT, the most studied advanced therapy, associated with lower mortality rates and improved RV recovery vs. systemic anticoagulation alone. However, this approach has significant issues with proper lytic dosing. Fried explained, “If there’s too much lytic, it can result in complications, such as stroke and death. If there’s too little lytic, the clot remains (residual pulmonary vascular occlusion), resulting in long-term morbidities, such as shortness of breath and exercise intolerance.”
Flow Medical’s innovative catheter solution aims to tackle the critical challenges of imprecise lytic dosing and residual pulmonary vascular occlusion. Three key features make this possible: a unique scaffold with hollow nitinol tubing, a fiber-optic sensor to monitor hemodynamics in real-time, and an outer sheath that enables simultaneous high-pressure diagnostic angiography.
The hollow nitinol tubing is engineered with laser-cut holes, allowing the thrombolytic agent to perfuse out and penetrate the clot from within. Fried elaborated, “We’re maximizing surface contact so every drop of tPA can be more effective, going directly into the clot and then going downstream.” The outer sheath facilitates simultaneous high-pressure diagnostic angiography, eliminating the need for physicians to swap out devices just to know where they are inside the patient.
The fiber-optic sensor enables physicians to track pulmonary artery (PA) pressure in real time on both the left and right sides of the patient, providing a real-time view of the heterogeneity in each patient’s response to a thrombolytic drug. Fried explained, “Right now, we have physicians that choose to infuse for two hours and physicians that infuse for 24 hours; there’s no rhyme or reason behind it. Because our device allows physicians to see PA pressure in real-time, they can customize therapy for each patient.”
Born out of the University of Chicago in 2020, Flow Medical was incorporated in 2022. The company’s first major milestone was securing funding through an NIH SBIR grant, which allowed them to develop their novel catheter-based design. Flow Medical also partnered with a local engineering group to fine-tune its solution, integrating key features such as hemodynamic monitoring.
Fried shared, “We recently raised $4.5M to get us off and running. We’re nearing a design freeze and are getting ready to kick off our design verification. We’re currently funded through the initiation of clinical studies, which we anticipate starting next year.”
Peripheral artery disease (PAD) is a global burden from both healthcare and economic perspectives. Despite the modernization of guidelines intended to improve the detection of PAD in its early stages, the disease remains widely underreported. As the disease progresses, it becomes more challenging to treat. Today, it’s estimated that at least 113 million people worldwide suffer from PAD. That figure may underestimate the overall burden of the disease, with some studies estimating the burden of PAD is similar to the burden of coronary artery disease (CAD), which affects approximately 250 million people worldwide.
Regarding VTE, it’s estimated that more than 1 in 12 people will experience deep vein thrombosis (DVT) or PE in their lifetime. This figure will only increase as the population gets older and, perhaps, more importantly, more unhealthy. As global obesity approaches “pandemic” levels, VTE levels will rise. Studies show that obesity is the most substantial causal lifestyle factor for VTE, with 10-30% of the population of people with a VTE being obese. Conservative estimates indicate that the global incidence of VTE is 10 million people every year.
VTE and PAD interventions continue to increase. According to LSI’s Market Analysis and Projections (MAP) database—a global database tracking and forecasting the spending on medical devices—the growth in total sales attributable to devices for treating PAD will exceed that of the sales attributable to devices for treating CAD. Valued at $7.2B in 2023, sales of devices for treating PAD will increase at a CAGR of 7.5%, reaching $10.3B by 2028. By 2031, LSI projects that the market for these devices will have nearly doubled.
Fried has been selected to present at LSI USA ‘25 next March 17-21 in front of hundreds of global medical technology companies. Join us in welcoming Fried to the event in Dana Point, CA, where she will share the latest updates on Flow Medical’s technology and development.
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