Pulse Biosciences (Nasdaq:PLSE) announced today that the FDA granted breakthrough device designation for its pulsed field ablation system. Shares of PLSE rose more than 20% in mid-morning trading on the back of this announcement.
Hayward, California–based Pulse Biosciences’ technology utilizes its CellFX nanosecond pulsed field ablation (nsPFA) technology and percutaneous electrode system, which the FDA cleared earlier this year. It enables the ablation of soft tissue in percutaneous and intraoperative surgical procedures.
Related: Avicenna.AI secures EU-MDR certification for five AI tools
The FDA granted the breakthrough nod for the company’s Cardiac Surgery System for ablating cardiac tissue to treat AFib. This system, which features a surgical clamp, produces durable, continuous transmural ablation lesions during cardiac surgery. The bipolar clamp utilizes the proprietary nsPFA technology.
Based on preclinical studies, a single application of less than two seconds creates a consistent, transmural ablation. Pulse Biosciences says this is significantly faster (1/20 of the time) than current thermal ablation technologies. Additionally, with its non-thermal mechanism, the system eliminates the risk of thermal spread that can damage collateral tissues.
Pulse Biosciences plans to pursue premarket approval to commercialize its nsPFA Cardiac Surgical System in the U.S. The company also expects to begin an AFib pivotal clinical trial in 2025.
“The breakthrough device designation granted by the FDA is an exciting milestone for Pulse. It emphasizes the unique potential benefits of nanosecond PFA,” said President and CEO 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.”
