Over breakfast with family friend Eric Sauter in 2012, Jerre Stead learned the University of Iowa chemical engineering student had recently won the Rice Business Plan Competition. “I said, ‘You’ve got to be kidding! That’s a big deal!”
Sauter was working with Steven Mickelsen, MD, an assistant professor at Iowa, who developed the idea for the Pulsed Field Ablation device to treat atrial fibrillation (AFib), an irregular heart rhythm that occurs when damaged or diseased tissue in the upper chambers of the heart emit chaotic electrical signals. AFib is the most common heart arrhythmia, often leading to blood clots and stroke, and is projected to affect over 12 million Americans by 2030.
While they won the Rice prize, they didn’t have a path to implementing their plan and commercializing their product. Jerre saw the potential. “I just knew this could be successful with the right support.”
Allan Zingeler met Farapulse founder Mickelsen at a heart conference in 2013 and Zingeler was immediately intrigued by the idea; Zingeler also knew Jerre. Zingeler came on as CEO of the company they named Farapulse and raised $5 million from angel investors, with Jerre as the initial investor making many introductions to others.
“I talked to Allan about once a month for eight years; it was wonderful to see the company take off,” said Jerre.
The company did its first human trials in Paraguay in 2016, and while successful, the device required a surgical approach. “We knew we needed to create a minimally invasive solution for broad physician adoption,” said Zingeler. “So, we switched gears to our second-generation device, Farawave. That was our pivotal minimal invasive PFA product, and we did our human trials in Prague in early 2018.”
Zingeler raised another $80 million in capital, and they applied for both FDA and European approval in 2020. Europe was set to approve stricter regulatory rules, but because of Covid the new rules were delayed. This allowed Farapulse to achieve approval in Europe in 2021, and by the time they received approval in the US in 2024, they had already treated over 40,000 patients in Europe with more than 100 clinical papers authored.
“Launching in the U.S. with that much data and support of the medical community in Europe really catapulted us,” said Zingeler.
FARAPULSE was acquired by Boston Scientific in late 2021. Boston Scientific CEO Mike Mahoney says Farapulse is the most transformational product he has seen in his 12-year career with the company.
The launch powered 85% growth in Boston Scientific’s U.S. electrophysiology business in the first quarter, compared to the same quarter last year. Mahoney said, “…It’s a remarkable platform, and we’re seeing excellent safety results, ease of use, rapid adoption, and excellent effectiveness.”
The Farapulse technology is having a tremendous impact on patients and the healthcare system. Because of the efficiency of the procedure, patients are on the table for a shorter period of time, and safety is increased. Healthcare systems can see twice as many patients, cutting waiting lists. And according to Zingeler, it is more effective. “Previous methods were shown to have 60-75% effectiveness, and the Farawave product has shown to have 80-90% effectiveness.”
“We were one of the first sites to adopt Farapulse after FDA approval, because we knew the benefit it would provide our patients with atrial fibrillation,” said Roderick Tung, MD, Director of the Cardiovascular Center at Banner – University Medical Center Phoenix. “The Farapulse technology provides a more efficient and effective treatment approach, which improves patient outcomes.”
One of Dr. Tung’s patients, Michael Olson, said, “My experience was completely positive, with zero post-ablation chest pain. My heart has been in normal sinus rhythm and functioning well since the procedure. My energy level is back, and my hope is restored for a long and full life. The procedure went flawlessly and after my 10:30 a.m. Farapulse ablation I was at a Pizzeria Bianco at 4:15 p.m. with my wife, ordering pizza.”
Reflecting on the success of Farapulse, Zingeler said, “Jerre’s support as a sounding board and problem solver was priceless. Being a CEO can be somewhat lonely; you’re supposed to have all the answers and you can’t always share with your team what you’re thinking. Jerre was a dynamic motivator and a cheerleader for me.”
