Pulse Biosciences, Inc. 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 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 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.