Just because pulsed field ablation therapy has yet to make its mark in the U.S. by clearing the FDA, that doesn’t mean there’s any reason to wait on developing version 2.0.
Field Medical is already working to redefine the nascent approach, with what it describes as the “next generation of pulsed electric field ablation technology.” The catheter-based procedure for atrial fibrillation aims to spare certain surrounding tissues from the damage that can come with traditional thermal ablation.
The California-based startup was founded last year by Steven Mickelsen, who previously helped launch the pulsed field ablation developer Farapulse—a company that was acquired by Boston Scientific for $295 million upfront in mid-2021, based on a system that is now approaching an FDA green light after previously claiming a European approval and a recent win in a U.S. pivotal trial.
But Field Medical believes there’s still room for improvement. While pulsed field ablation treats an irregular heartbeat using short bursts of electric energy tuned to disrupt contracting cardiac muscle cells without overheating tissues—and without harming nearby nerve cells and organs such as the esophagus—the company aims to hone the technology further by shaping and concentrating those electric fields, while also addressing other safety challenges.
To support its plans, Field Medical has collected a $14 million seed round consisting of convertible note funding backed by private and strategic investors, the company said in its announcement. Those plans include a goal of launching first-in-human clinical trials in early 2024, as well as eventually tackling electrophysiology procedures and arrhythmias outside of intermittent afib.
“In today's uncertain investment climate, we are thrilled to have attracted such strong attention from the investor community and strategic partners,” said Mickelsen, who serves as CEO.
Field Medical estimates it will enter a $3.6 billion cardiac catheter ablation market that is already growing about 14% annually.
In August, Boston Scientific’s Farapulse system showed it can operate on par with traditional ablation methods while demonstrating fewer complications in a head-to-head trial. Meanwhile, Medtronic’s PulseSelect ablation device posted a study earlier this year showing that 70% of patients with paroxysmal afib and 62% with persistent afib went arrhythmia-free for one year.
Additionally, this week Johnson & Johnson MedTech's Biosense Webster division declared the start of a 135-patient clinical trial in Europe of its Omnypulse pulsed fiedl ablation catheter, featuring heart mapping technology.
Previously, Field Medical announced a collaboration with CardioNXT to develop a “purpose-built system” integrating its focal pulsed field ablation technology with the latter’s 3D heart mapping and navigation platforms—with the goal of minimizing the use of X-ray imaging during procedures.
“[Pulsed field ablation] has generated much excitement in the treatment of atrial fibrillation due to an improved safety profile and procedural workflow. However, most of the first generation PFA technologies today are repurposed from other applications and suffer from significant limitations outside a subset of afib procedures,” Mickelsen said in the December 2022 release. “This collaboration brings together second-generation focal PFA and AI-based cardiac mapping—a combination set to revolutionize catheter ablation across the full spectrum of treatable arrhythmias.”