Synkopi Medical, led by co-founder and CEO Suresh Gurunathan, has joined Fogarty Innovation’s Company Accelerator Program (CAP). The company is developing PatHFinder, a bi-atrial pressure (BAP) monitor designed to improve medical management of heart failure and reduce hospitalization and mortality. The battery-powered PatHFinder combines a novel custom-built pressure sensor with a wireless communication system to safely and reliably measure vital parameters and transmit them to a base station.
The market is significant: The company will initially target NYHA Class II and Class III heart failure patients, which Gurunathan says constitutes over 1.8 million patients in the United States. This number roughly doubles when including patients in Europe, where the company plans to expand after achieving FDA approval.
The company has demonstrated feasibility of the device in preclinical trials and is currently fundraising with the goal of initiating early feasibility studies in humans by late 2026.
Simplifying care for patients and physicians
Gurunathan cites several factors that differentiate PatHFinder, the first battery-powered device of its kind, from competitors. PatHFinder will measure left as well as right atrial pressures, which will help phenotype both left and right sided heart failure in patients.
First, it automatically measures pressure and other key parameters throughout the day. The device then wirelessly transfers the data to a base station which in turn uploads it to the cloud.
“The device is designed to support patient-based self-monitoring, similar to the way diabetes patients monitor their own glucose levels. The intent is for physicians to program the prescription and have patients be able to adjust their medication automatically at home based on their left and right atrial pressures. It would be a huge advantage for doctors to no longer have to see the patients on a weekly basis,” Gurunathan said, adding that they plan to include guardrails that send an alarm to the physician or caretaker if needed.
Other design considerations include device fixation to leave enough space in the septum for a future interatrial shunt, an increasingly common therapy for heart failure patients, and to allow subsequent transseptal access such as for mitral valve repair and left atrial appendage closure.
A team well-versed in cardiac treatment and startup culture
With more than 28 years of experience in the medical device industry, Gurunathan is drawing on his background not only as program director at Abbott but with startups such as Nanostim/Aveir and NeuroPace to make the key decisions that will guide the company’s trajectory.
The monitor idea had initially been conceived by co-founder Alan Ostroff, who has done much work in active implantable devices and had a personal reason to pursue heart failure solutions, since he had lost a family member to the condition. Ostroff knew Gurunathan from their time together at Nanostim and asked him to run Synkopi as CEO, while he served as CTO.
After seeking input from multiple doctors, they zeroed in to focus on bi-atrial pressure monitoring. Gurunathan then approached Frank Fischer, his previous CEO at NeuroPace, who was so impressed with the concept and team that he was willing to invest in the company and serve as the chairman of the Synkopi board.
At that point they were full steam ahead, building out the team and conducting a friends-and-family round of investment while developing key pieces of the technology.
Tapping Fogarty’s expertise
Gurunathan recognized that joining Fogarty Innovation might help bolster some of the additional work he needed to complete – from the business plan through commercialization – and, when he spoke with other CAP and CIR companies, he was convinced that the Fogarty staff had the skill sets to provide him with the right coaching.
“The more I thought about it and discovered Fogarty’s strengths, the more I recognized the credibility they bring with their branding and reputation, not to mention the facilities and expertise from CEO Andrew Cleeland, board member Fred St Goar, MD, and the entire team,” Gurunathan said.
After joining, he quickly realized another benefit—the opportunity to collaborate alongside fellow entrepreneurs. “It’s just a great place to share ideas. I’m going through fundraising now, and because everybody’s always fundraising, I can bounce ideas off the other CEOs, who understand the challenges. It feels good to be in an environment where I don’t feel as though I am alone in any aspect of our progress.”