Medtech success stories are always inspiring and there is nothing better than hearing one from a Fogarty alumni company. Joe Eibl, CEO of Flosonics, visited FI earlier this month to give a Lunch & Learn educational talk describing his company’s journey from participation in Fogarty’s Company Accelerator Program (CAP) to a commercial launch this year. El Camino Hospital, which worked closely with the Flosonics team during their time in the CAP program, is one of the U.S. hospitals leading that commercial launch.
Flosonics was selected to join the CAP program shortly after the company received regulatory clearance for its core technology – a wearable, wireless Doppler ultrasound sensor called FloPatch. CAP is a six-month, cross-functional mentoring program that helps early-stage companies hone their business model and make progress towards key milestones.
Doppler ultrasound is used to estimate how fast blood flows through the vessels. There are numerous clinical scenarios where this information is important, however, it is typically done in the ultrasound or radiology department. The FloPatch allows a clinician to monitor blood flow continuously, in real time, at the bedside.
“When we came to FI we were focused on the technology,” recalled Joe. Our value proposition was “The world’s first wearable wireless Doppler.” Then the Flosonics team met with their lead FI mentors, Mike Regan and Zach Edmonds, MD, who refocused the conversation on why the technology mattered to patients. “Mike’s comment was, ‘So what and who cares?’ and Zach’s question was, ‘How do I use this clinically?” described Joe. The questions prompted the Flosonics team to shift the frame and put the patient at the center of their thinking.
Working with their FI advisors, the team went back to the unmet clinical need they had developed the FloPatch to address – a way to manage fluids in critically-ill patients. They developed a model patient named Stan, a 57-year-old man with a history of heart failure, and let his clinical journey guide their next steps.
Joe described a scenario where Stan comes to the emergency room with sepsis and is immediately put on the standard protocol – three liters of IV fluids. While this is the accepted first line therapy for sepsis, it is a lot of fluid for someone with heart failure. “The problem is that while the first liter of fluid may be effective in increasing blood flow and preventing shock, the second and third liter may not,” said Joe.
But there is no easy way for the clinician to tell. “We’re not really great at understanding which patients are benefiting from fluids and which aren’t,” said Joe. “And if you overload a patient like Stan with fluids, he will need to go to the ICU, and may require mechanical ventilation and a much more complex course of care.”
While fluid overload is a challenging clinical dilemma, the lack of good alternatives had fostered problem blindness. To address this, Flosonics worked with FI to design a study to quantify the magnitude of the problem. “We had to help people understand a problem that they may not even be aware that they had,” said Joe.
The study looked at patients who came through the emergency department and received fluids and revealed that more than a third of the total fluids delivered were ineffective. “This is a costly problem from multiple perspectives – it takes about an hour to administer a liter of fluid, you have a patient occupying an emergency room bed who could potentially be moved to a different unit, there is the decision time spent determining how to best to triage the patient, and there is the cost and risk associated with treating the fluid overloaded patient,” said Joe. The study results presented a compelling argument for real-time, beat-to-beat, hemodynamic monitoring offered by the FloPatch, which makes it easy for caregivers to continually assess whether or not a patient is benefitting from fluids.
Over the course of the next 12 months, Flosonics surveyed all the ECH hospital units involved in giving IV fluids to patients, with the goal of showing efficacy for use and effectiveness in identifying fluid responsiveness. “The key players were clinical specialists who really understand the workflow and what happens when you overload patients with fluid,” recalled Joe.
With their new value proposition as “helping you know when to put the brakes on IV fluid,” Flosonics had identified a strong beachhead market for commercialization. The company graduated from FI and several months later, had contracts from Canada and then from the U.S. military. The company is also using its patient-centric focus to develop thoughtful research studies that will demonstrate the value of FloPatch for other indications.
“CAP was about understanding the patient journey and who we were going to talk to,” said Joe. “It helped us understand the job to be done, who we are impacting and how, and generate customer-specific evidence to quantify the burden and benefit of our solution.” He concluded, “Our mentors at Fogarty helped us go slow to go fast.”