MIAMI– Pulse Biosciences, Inc. (Nasdaq: PLSE) (the “Company” or “Pulse Biosciences”), a company leveraging its novel and proprietary Nanosecond Pulsed Field Ablation™ (nsPFA™) technology, today announced that it has received the Breakthrough Device Designation from the U.S. FDA for the Company’s Cardiac Surgery System for the ablation of cardiac tissue for the treatment of atrial fibrillation (AF).
Pulse Biosciences’ 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 2 seconds with the Surgical Clamp creates a consistent, transmural 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 science behind nanosecond pulse field ablation was immediately compelling to me. The theoretical benefits of short-duration, high-amplitude energy pulses with a nonthermal mechanism of action suggest the potential for a safer and more effective treatment. The preclinical data convinced me this technology could significantly advance the surgical treatment of atrial fibrillation. The FDA recognized Pulse’s Cardiac Surgery System as Breakthrough and we look forward to continuing our work to provide access to this technology to patients and surgeons as quickly as possible,” said Dr. Niv Ad, Chief Science Officer, Cardiac Surgery of Pulse Biosciences.
The Breakthrough Devices Program is a voluntary program for certain medical devices with the potential to provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions, such as atrial fibrillation. The Breakthrough Devices Program is intended to provide patients and health care providers with timely access to medical devices by speeding up development, assessment, and review for premarket approval, 510(k) clearance, and De Novo marketing authorization. Breakthrough Devices must still meet the FDA’s rigorous standards for device safety and effectiveness in order to be authorized for marketing.
“The Breakthrough Device Designation granted by the FDA is an exciting milestone for Pulse. It emphasizes the unique potential benefits of nanosecond PFA,” added President and Chief Executive Officer Burke T. Barrett. “We plan to fully leverage the benefits of this designation and have chosen to seek PMA approval to achieve a specific indication for the treatment of atrial fibrillation. We look forward to aligning with the FDA on a pivotal clinical trial design in the near-term and towards initiating our planned first-in-human cases in the Netherlands soon.”
The Company now plans to pursue the premarket approval (PMA) application pathway for FDA approval to market as opposed to the 510(k) route, and once FDA PMA approved, commercialize the nsPFA Cardiac Surgical System in the United States as a treatment for atrial fibrillation. Once granted by the FDA, a specific treatment indication would permit direct marketing of the treatment benefits provided by the device. The Company expects to begin its pivotal clinical trial for AF in 2025 and will provide additional details on the study and its regulatory and commercial implications later this year.
“The preclinical results we have generated with the Cardiac Surgery System have been outstanding and I expect to see similar results in the initial clinical procedures in the Netherlands later this year. Nanosecond PFA has the potential to be a revolutionary advancement for the surgical treatment of atrial fibrillation. I am excited to help design the pivotal clinical trial to support a future PMA submission,” stated Dr. Gan Dunnington, Chief Medical Officer, Cardiac Surgery of Pulse Biosciences.
