Pulse Biosciences, Inc. (NASDAQ: PLSE) has enrolled the first seven patients in its NANOPULSE‑AF study, a prospective, multicenter, investigational device exemption (IDE) pivotal trial of the nPulse Cardiac Catheter System for treating recurrent, drug‑resistant, symptomatic paroxysmal atrial fibrillation. The study began on April 7 2026 and will enroll patients at multiple U.S. sites to evaluate the safety and effectiveness of the company’s nanosecond pulsed‑field ablation (nsPFA) technology in a high‑risk AF population.
The enrollment milestone marks a significant step in Pulse’s development roadmap, bringing the company closer to potential regulatory approval and commercialization of its cardiac catheter platform. Pulse has been investing heavily in clinical development; in Q4 2025 the company reported a GAAP net loss of $72.8 million and a non‑GAAP net loss of $0.26 per share, with cash and cash equivalents at $80.7 million as of December 31 2025. The first‑patient enrollment demonstrates the feasibility of the nsPFA approach and supports the company’s strategy to accelerate the regulatory pathway.
"This is a promising technology, and our team is pleased to have enrolled and treated the first patients in this pivotal trial. The performance of the nPulse System, combined with integrated catheter mapping using the investigational EnSite X software from Abbott, provides a very user‑friendly experience and supports an efficient, reproducible and streamlined workflow. This approach may potentially offer important advantages compared with existing technologies. I look forward to continued enrollment and further clinical evaluation of this strategy in atrial fibrillation ablation for the betterment of all involved," said Dr. Devi Nair, Principal Investigator of the Arrhythmia Research Group. "Enrolling the first patients in this study marks an important milestone for the Company as we build on the encouraging results from our impressive feasibility experience. With our nanosecond pulsed field ablation technology and the cardiac catheter's novel design, we are advancing an entirely differentiated approach that we intend to significantly alter AF treatments. We're thrilled by this strong start to the NANOPULSE‑AF study and look forward to its rapid expansion," added Darrin Uecker, CTO and Board Member. "I am excited to initiate our IDE study with Dr. Nair, a leader in the EP ablation space. This marks an important advancing next step in the clinical development of our nanosecond PFA platform. Building on encouraging first‑in‑human data demonstrating safety, procedural efficiency, durable pulmonary vein isolation, and ease of use, our catheter is now tightly integrated with the Abbott EnSite X 3D electroanatomical mapping system, enabling accurate catheter visualization, navigation and contact assessment to support optimal PFA delivery," said David Kenigsberg, MD, FACC, FHRS, Chief Medical Officer.
Vivek Reddy, MD, Director of Cardiac Arrhythmia Services at the Mount Sinai Fuster Heart Hospital, NY, noted, "These 6‑ and 12‑month data demonstrate a strong safety profile with highly effective and durable PVI achieved with the nPulse Cardiac Catheter Ablation System, suggesting that this system has the ability to considerably advance the treatment of atrial fibrillation (AF)."
Pulse’s nsPFA technology differentiates itself from other pulsed‑field ablation systems such as Medtronic’s PulseSelect and Boston Scientific’s Farapulse by delivering nanosecond pulses that target intracellular structures while sparing surrounding tissue. The company is also exploring broader applications, including benign thyroid tumor ablation and surgical soft‑tissue ablation, and has begun a research collaboration with the University of Texas MD Anderson Cancer Center to evaluate nsPFA for thyroid tumors.
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