Pulse Biosciences Enrolls First Patient in NANOCLAMP AF Study, Marking Major Milestone in Atrial Fibrillation Treatment Innovation
Pulse Biosciences, Inc. (Nasdaq: PLSE), a company pioneering next-generation medical technologies through its proprietary nPulse™ platform and Nanosecond Pulsed Field Ablation™ (nsPFA™) energy, has announced the enrollment of the first patient in its NANOCLAMP AF Study — a landmark clinical trial investigating the use of its nPulse™ Cardiac Surgical System for the treatment of atrial fibrillation (AF).
The first successful procedure was recently completed at St. Helena Hospital in St. Helena, California, marking a significant advancement following the U.S. Food and Drug Administration’s (FDA) approval of an Investigational Device Exemption (IDE) for the study. The achievement represents a crucial step forward in demonstrating the safety and efficacy of Pulse Biosciences’ novel, nonthermal ablation approach to cardiac surgery.
A New Chapter in Atrial Fibrillation Treatment
The NANOCLAMP AF Study is a single-arm, prospective, multicenter clinical trial designed to evaluate the safety and effectiveness of the nPulse Cardiac Surgical System for the treatment of atrial fibrillation during concomitant cardiac surgical procedures. The study aims to enroll patients across multiple sites, including several locations outside the United States, to build a robust and diverse clinical data set supporting future regulatory submissions and broader adoption of nsPFA technology.
Atrial fibrillation remains the most common cardiac arrhythmia, affecting millions worldwide. Current treatment methods, such as radiofrequency and cryoablation, rely on thermal energy to destroy abnormal heart tissue that causes irregular rhythms. While effective, these approaches carry the risk of collateral damage to surrounding cardiac structures, particularly the esophagus and coronary arteries. Pulse Biosciences’ nonthermal nsPFA energy, however, seeks to overcome these limitations by precisely targeting cardiac tissue using ultrashort, high-voltage electrical pulses that selectively disrupt cell membranes without generating heat.
Surgeons Praise Early Experience with nPulse Technology
Dr. Gan Dunnington, Cardiothoracic Surgeon at Adventist Health, who performed the first U.S. procedure alongside Dr. Aaron Kime and the surgical team, highlighted the clinical and procedural advantages of nsPFA technology.
“After years of development, it is an honor to perform the first NANOCLAMP AF surgical procedure in the U.S. using nanosecond PFA,” said Dr. Dunnington. “This marks a major leap forward for cardiac surgery. The nPulse Cardiac Clamp was not only intuitive to use but also delivered treatments faster than expected. My team was impressed by the technology’s simplicity, speed, and consistency in achieving full ablation lines. Having observed this device’s use in European clinical studies, I am confident it has the potential to redefine how we treat atrial fibrillation in the surgical setting.”
His remarks underscore the excitement within the cardiovascular community surrounding nsPFA’s potential to enable faster procedures, minimize complications, and deliver more consistent outcomes.
Transforming the Landscape of Cardiac Ablation
Dr. Matthew Romano, the National Principal Investigator for the NANOCLAMP AF Study and Professor of Cardiac Surgery at the University of Michigan, emphasized the groundbreaking implications of this technology for future cardiac care.
“This trial represents a pivotal moment in our mission to transform patient outcomes,” Dr. Romano stated. “nPulse technology offers an improved safety profile due to its nonthermal mechanism of action, which avoids damage to nearby structures while still producing precise, durable, full-thickness lesions. The ability to achieve this level of accuracy in a fraction of the time compared to traditional methods could revolutionize concomitant ablation procedures. We expect that these advances will ultimately expand treatment access to more patients and improve long-term results.”
The ability to consistently create durable ablation lines is essential for successful AF treatment. Traditional thermal ablation techniques can suffer from variability in lesion depth and continuity, potentially leading to incomplete isolation of arrhythmogenic tissue. Pulse Biosciences’ bipolar nsPFA system aims to overcome these challenges, producing uniform, transmural ablation lines that maintain structural integrity while minimizing collateral damage.
Inside the nPulse™ Cardiac Surgical System
The nPulse™ Cardiac Surgical System represents a next-generation bipolar surgical ablation platform developed to enable cardiac surgeons to perform safe, efficient, and precise ablation during open or minimally invasive procedures. Unlike thermal methods that rely on heating or freezing tissue, nsPFA technology uses nanosecond-scale electric pulses to irreversibly permeabilize cell membranes, leading to targeted cell death while preserving noncellular components like collagen and elastin.
This nonthermal energy modality is expected to deliver several advantages over conventional ablation tools:
- Enhanced safety by avoiding heat-related injury to surrounding structures.
- Consistent, full-thickness lesions across varying tissue conditions.
- Rapid ablation in a fraction of the time compared to radiofrequency energy.
- Ease of integration into existing cardiac surgical workflows.
The system’s design allows surgeons to perform precise, continuous ablation lines in less time, potentially reducing procedure duration and postoperative complications.
The nsPFA Cardiac Surgical System received FDA Breakthrough Device Designation in July 2024, recognizing its potential to offer more effective treatment for AF patients compared to currently available therapies. The system is also part of the FDA’s Total Product Life Cycle (TPLC) Advisory Program (TAP), an initiative designed to accelerate the development and review of innovative medical devices.
Building Momentum Following FDA IDE Approval
According to Dr. Niv Ad, Chief Scientific Officer of Cardiac Surgery at Pulse Biosciences, the rapid enrollment of the first patient underscores the growing enthusiasm for nsPFA among cardiac surgeons.
“Treating our first patient so soon after the IDE approval highlights the high level of interest and excitement surrounding nanosecond PFA,” Dr. Ad said. “We believe this study will demonstrate clear benefits of nsPFA in terms of procedural efficiency, safety, and long-term efficacy. These results could catalyze widespread adoption of surgical cardiac ablation and set a new standard of care for atrial fibrillation.”
Dr. Ad added that the company is collaborating closely with top cardiac surgeons and medical centers worldwide to accelerate clinical validation and data collection. “We are deeply grateful to all the clinicians who have supported our work from the start. Their expertise and collaboration are critical as we continue advancing the field of cardiac surgery.”
The Road Ahead for Pulse Biosciences
With the first patient successfully treated, Pulse Biosciences is now focused on expanding enrollment across its planned study sites in the U.S. and abroad. The company aims to collect robust clinical evidence supporting nsPFA’s safety and performance, which could pave the way for FDA market clearance and broader commercialization of the nPulse system in surgical cardiac procedures.
The NANOCLAMP AF Study represents one of several clinical efforts by Pulse Biosciences to validate nsPFA across multiple therapeutic areas. The company’s proprietary platform technology is being evaluated for potential applications beyond cardiac surgery, including dermatology, oncology, and other interventional medical specialties where precise, nonthermal ablation could deliver improved patient outcomes.
As the clinical data from NANOCLAMP AF continue to emerge, Pulse Biosciences hopes to solidify its leadership in pulsed field technology and drive a new era of nonthermal energy-based medicine.
A Defining Moment in Cardiac Innovation
The first enrollment in the NANOCLAMP AF Study is more than just a procedural milestone—it marks a defining moment in the evolution of atrial fibrillation treatment. By combining cutting-edge engineering, a nonthermal energy approach, and the collaborative efforts of leading cardiac surgeons, Pulse Biosciences is setting the stage for a paradigm shift in how arrhythmias are treated during surgery.
If successful, the nsPFA technology could significantly reduce treatment times, improve outcomes, and expand access to safe and effective ablation therapies for countless patients worldwide.
With its first U.S. patient now successfully treated and an ambitious clinical roadmap ahead, Pulse Biosciences stands at the forefront of innovation, redefining what’s possible in the treatment of cardiac rhythm disorders through the power of nanosecond precision.
About Pulse Biosciences®
Pulse Biosciences is a novel bioelectric medicine company committed to health innovation that has the intention as well as the 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 noncellular tissue. 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, such as surgical soft tissue ablation.
Pulse Biosciences, nPulse, Vybrance, CellFX, Nano-Pulse Stimulation, NPS, nsPFA, CellFX nsPFA, nanosecond PFA and the stylized logos are among the trademarks and/or registered trademarks of Pulse Biosciences, Inc. in the United States and other countries.
