Pulse Biosciences, Inc. Announces Successful Treatment of Patients in First-in-Human Study with its Nano-PFA Cardiac Surgery System
Pulse Biosciences press release
MIAMI--(BUSINESS WIRE)--Pulse Biosciences, Inc., a company leveraging its novel and proprietary Nanosecond Pulsed Field Ablation™ (nsPFA™) technology, today announced treatment of the first two patients in the first-in-human feasibility study using its novel Cardiac Surgery System for the ablation of cardiac tissue for the treatment of atrial fibrillation.
Dr. Bart Van Putte, Cardiothoracic Surgeon at St. Antonius Hospital, used the Company’s Cardiac Surgery System to successfully treat two patients with atrial fibrillation at St. Antonius Hospital, Nieuwegein, The Netherlands. Dr. Van Putte was joined by colleagues and Pulse Biosciences’ Chief Medical Officer, Cardiac Surgery, Dr. Gan Dunnington and Chief Science Officer, Cardiac Surgery, Dr. Niv Ad during the concomitant procedure. The first-in-human feasibility study is a multicenter study of up to 30 patients that will include an endocardial catheter-based remapping to confirm chronic isolation at approximately three months post treatment.
“We are honored to partner with Pulse Biosciences and to be the first team to use this next-generation nano-PFA technology for the treatment of atrial fibrillation in cardiac surgery. The initial procedure results showed effective pulmonary vein and ‘box’ isolation with Pulse’s Cardiac Surgery System,” said Dr. Bart Van Putte, Cardiothoracic Surgeon at St. Antonius Hospital. “We were impressed by how rapidly and effectively we were able to produce linear ablations in a fraction of the time it takes with the current thermal modalities we use, such as radiofrequency or cryoablation.”
“These initial treatment results confirm our preclinical work with the cardiac surgical system. The patients tolerated our procedure well. We are pleased to see how the intuitive design of the device facilitates an efficient procedure where surgeons can create controlled lesions with adequate depth very rapidly,” added Dr. Gan Dunnington, Chief Medical Officer, Cardiac Surgery of Pulse Biosciences. “We are excited to continue enrollment in this feasibility clinical study, which is intended to demonstrate the device’s safety, effectiveness and durability profile.”
Pulse’s Cardiac Surgery System with Surgical Clamp is designed to produce durable, continuous, transmural, ablation lesions during cardiac surgery procedures for the treatment of atrial fibrillation. The bipolar clamp utilizes the Company’s proprietary nanosecond PFA technology. Based on pre-clinical studies, a single application of less than two seconds with the Surgical Clamp creates a consistent, transmural, durable ablation, which is significantly faster, requiring approximately one-twentieth the time of currently available thermal ablation technologies. Also, due to the non-thermal mechanism of action of nano-PFA, there is no risk of thermal spread that may cause undesired injury to collateral tissues, which compares favorably to thermal radiofrequency ablation.
The nano-PFA Cardiac Surgical System received FDA Breakthrough Device Designation in early July 2024. Recently the device was enrolled in the FDA’s TAP program. The FDA’s Center for Devices and Radiological Health (CDRH) launched the TAP program to help generate more rapid development of high-quality, safe, effective, and innovative medical devices that are critical to public health. TAP’s primary goal is to expedite patient access to innovative medical devices by providing early, frequent and strategic communications with the FDA and facilitating engagement with other key parties for developers of devices of public health importance. According to its website, the FDA has enrolled 46 devices in the TAP program to date, while there have been over 900 Breakthrough Device Designations granted.
“We continue to make great strides on the development of our current nano-PFA devices, three of which have now been used in patients with initial promising results. We are grateful for all the key opinion leader clinicians who have partnered with us to advance nano-PFA technology for the benefit of patients and clinicians worldwide,” stated President and Chief Executive Officer Burke T. Barrett. “These initial clinical results with the Cardiac Surgical System will inform the next steps of our clinical and regulatory strategy. We are excited to continue the momentum with the System following its Breakthrough Device Designation and recent enrollment into the prestigious TAP program. Moving forward, we intend to submit for IDE approval from the FDA to begin U.S. clinical work.”
The Company plans to pursue FDA premarket approval (PMA) to commercialize its nano-PFA Cardiac Surgical System in the United States as a treatment for atrial fibrillation. If granted by the FDA, a specific treatment indication would permit direct marketing of the device’s treatment benefits. The Company intends to begin its pivotal clinical study of its nano-PFA Cardiac Surgical System as a treatment for atrial fibrillation in early 2025 and will provide additional details on the study and its regulatory and commercial implications later this year.
About Pulse Biosciences®
Pulse Biosciences is a novel bioelectric medicine company committed to health innovation that has the potential to improve the quality of life for patients. The Company’s proprietary CellFX® nsPFA™ 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 CellFX nsPFA 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 is now headquartered in Miami, Florida and maintains its office in Hayward, California.
Pulse Biosciences, 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.
