Pulse Biosciences Surpasses Enrollment Midpoint in NANOPULSE-AF IDE Pivotal Study
Pulse Biosciences Press Release
HAYWARD, Calif. -- Pulse Biosciences, Inc. (Nasdaq: PLSE), a company leveraging its novel and proprietary Nanosecond Pulsed Field Ablation™ (nano-PFA or nsPFA™) technology, today announced that the NANOPULSE-AF Study has surpassed its enrollment midpoint after commencing the study in April 2026.
“We are very pleased by the strong enrollment trajectory in the NANOPULSE-AF study. Reaching this midpoint milestone so quickly reflects the enthusiasm of our investigational sites for this technology and its potential to deliver leading durability in pulmonary vein isolation, procedural efficiency and consistent safe and effective patient outcomes,” said David Kenigsberg, MD, FACC, FHRS, Chief Medical Officer of Pulse Biosciences. "This momentum is driven first by the technology itself. Second, the protocol represents a real-world example of the type of patients we are seeing in clinical practice, where ablation has become a first-line therapy to address patients suffering from atrial fibrillation. We appreciate our close collaboration with the FDA throughout this process, as we move toward completion of our IDE study."
"The nPulse System has been a remarkably intuitive platform to work with. The learning curve is minimal, and the workflow integrates seamlessly into our existing ablation practice," said Frank Cuoco, MD, FACC, FHRS, Director of Cardiac Electrophysiology at HCA Trident Health in Charleston, South Carolina, and a top-enrolling investigator in the NANOPULSE-AF Study. "That ease of use is a meaningful driver of the momentum we're seeing in enrollment, and the nPulse System has already demonstrated the potential to be a safe and durable treatment option for our patients. That combination is what is bringing patients into the study so quickly."
"Having experience with this catheter during the first-in-human cases in Prague, I was excited to get this IDE study started in the United States," said Vivek Reddy, MD, Director of Cardiac Arrhythmia Services at the Mount Sinai Fuster Heart Hospital, NY, and National Principal Investigator of the NANOPULSE-AF Study. "Reaching the halfway mark so rapidly is a true testament to the ease of use of this catheter, and the excitement it engenders in the investigators. Having seen the compelling safety and efficacy data in the first-in-man dataset, I look forward to evaluating the full pivotal dataset with my fellow investigators upon the study's completion."
The Company will provide additional commentary on the progress of the Study during its upcoming earnings conference call on August 6th at 1:30pm PT / 4:30pm ET. Investors interested in listening to the conference call may do so by dialing 1-800-715-9871 from the U.S. or 1-646-307-1963 internationally and providing Conference ID 3486060. A live and recorded webcast of the event will be available on the Pulse Biosciences Investors website at http://investors.pulsebiosciences.com/.
About Pulse Biosciences®
Pulse Biosciences is a novel bioelectric medicine company committed to health innovation that has the intention as well as potential to improve the quality of life for patients. The Company’s proprietary nPulse™ technology delivers nanosecond pulses of electrical energy to non-thermally clear cells while sparing adjacent non-cellular tissue as well as initiating regulated cell death. The Company is actively pursuing the development of its nPulse technology for use in the treatment of atrial fibrillation and in a select few other markets where it could have a profound positive impact on healthcare for both patients and providers.
Pulse Biosciences, nPulse, Vybrance, CellFX, Nano-Pulse Stimulation, NPS, nsPFA, CellFX nsPFA and the stylized logos are among the trademarks and/or registered trademarks of Pulse Biosciences, Inc. in the United States and other countries.
