A photo of Flow Medical co-founders (from left) Dr. Jonathan Paul, Jennifer Fried and Dr. Osman Ahmed.

Flow Medical co-founders (from left) Dr. Jonathan Paul, Jennifer Fried and Dr. Osman Ahmed [Photo courtesy of Flow Medical]

Jennifer Fried has joined medtech startup Flow Medical as CEO and co-founder, she said this week in an exclusive interview with Medical Design & Outsourcing.

Fried was previously co-founder and CEO of Explorer Surgical, which sold to GHX in 2021. She resigned from the company in June 2022, leaving us to wonder what was next for the venture capital investor.

One year later, she’s an investor and the chief executive at Flow Medical. The Chicago-based startup is developing a new catheter system for treating pulmonary embolism (PE). PE is caused by blood clots that break off from deep vein thrombosis (DVT) and head to the lungs. Of the estimated 900,000 PE cases in the U.S. each year, around 100,000 are fatal.

The other two co-founders of Flow Medical are Chief Scientific Officer Dr. Jonathan Paul and Chief Medical Officer Dr. Osman Ahmed. They both practice medicine at the University of Chicago Medical Center: Paul is an interventional cardiologist, while Ahmed is an interventional radiologist.

The two doctors came up with the idea for their catheter-directed thrombolysis (CDT) device in December 2020. They had both just received their first COVID-19 vaccine dose and were sitting together during the brief post-injection observation period.

“It’s rare and unique for interventional radiologists and interventional cardiologists to be friends to begin with,” Ahmed said. “We’re both very passionate about DVT and PE. … During COVID, the number of DVT and PE cases just exploded because there was this association with the virus making a patient prone to developing clots. A lot of patients at that time were started on blood thinners as soon as they were diagnosed with COVID-19. It was really at the forefront of our minds.”

As the two doctors discussed the limitations of current PE treatments and the shift from thrombolysis toward thrombectomy, they saw an opportunity to innovate with a new device. Today, they have a prototype three-in-one angiography, infusion, and monitoring CDT system.

Flow Medical’s catheter-directed thrombolysis system

Flow Medical designed its steerable catheter to navigate to the blood clot and deploy an expandable basket. Made of nitinol, that basket engages with the clot and delivers clot-busting tissue plasminogen activator (tPA) medicine directly into the blockage. The basket’s length is adjustable to match the size of the clot.

Nitinol’s superelastic properties allow the basket to compress down into a slim profile — the team is targeting an 8 Fr catheter size — and expand inside the pulmonary artery, then compress back down into the catheter for removal.

The catheter system will also have built-in angiography capabilities to perform a diagnostic quality pulmonary angiogram to help the interventionalist locate the clot and navigate the catheter within the clot.

“This is something we commonly and routinely do,” Ahmed said. “But it requires an exchange with a different device. The goal is to make a relatively painless procedure even more painfree.”

The most important feature, Ahmed said, might be the system’s ability to monitor pulmonary blood pressure.

“CDT is an imperfect science. Currently, we infuse the medication for a pre-set time and leave it in the patient, but unfortunately that’s very imprecise and can lead to bleeding complications,” Ahmed said. “Being able to monitor [pulmonary pressure] in real-time will allow us to discontinue the procedure exactly when we need to.”

The largest design challenge will be packing all those features into an 8 Fr catheter, which is slightly larger than current CDT devices but much smaller than mechanical thrombectomy catheters. The team’s latest prototypes are currently in the 10-11 Fr range.

“We have all the components, and everything we’re pretty happy with,” Ahmed said. “We’re trying to just now miniaturize it into 8 Fr, which is doable. We’re working on making sure we have a prototype that we’re happy with and then just shrinking it down a little bit.”

They’re working with contract development and manufacturing organization Medical Murray as well as Ontogen Medtech co-founder Tyler Panian. Panian was formerly director of R&D at Endotronix, which developed the Cordella pulmonary artery pressure sensor implant.

“We’re confident in our engineering teams,” Ahmed said. “We’ve been making great progress, really only limited by supply chain shortages that everybody’s experienced.”

How Fried met Flow Medical

One of Fried’s former investors is Dr. Steve Gould, the consulting director for Polsky Science Ventures at the University of Chicago’s Polsky Center for Entrepreneurship and Innovation. Fried said Gould — a Flow Medical advisor and board member — had been trying to get her to take a look at the startup ever since Explorer Surgical’s sale to GHX.

In February, he tried again, and Fried agreed to meet Paul and Ahmed to explore an advisory role.

“They were so passionate and also so confident that they did not have the tools that they needed as physicians to do right by these patients,” Fried said. “And that’s why I said, ‘I want to help you.’ I did not go into the advisory relationship thinking I was going to be the CEO of another early-stage company.”

One factor that made a difference: Fried said her father was diagnosed a few years ago with a rare form of blood cancer that makes him more likely to have blood clots.

“I wanted to know how to take care of my dad, if and when that time came,” she said. “Because of that, I just really wanted to dig in.”

“Jennifer completes our team,” Paul said in a statement. “Jennifer’s experience building early-stage healthcare companies as both an investor and operator will enable us to rapidly accelerate our efforts to bring our novel device to market to serve our patients.”

As CEO, she’ll help Flow Medical build its team and select a path for regulatory approval while fundraising.

The company has already won Small Business Innovation Research (SBIR) funding from the National Institutes of Health and plans to apply for a phase II SBIR grant. Fried also said Flow Medical is backed by a medical device manufacturer, but declined to name the strategic investor.

“Getting Jennifer has been one of our biggest milestones,” Ahmed said. “In our first meeting with Jennifer, we just both knew she was the right person. … Her expertise, her knowledge, her enthusiasm —  she loves this as much as we do.”