Pulse Biosciences Announces First U.S. Procedure with the CellFX nsPFA Percutaneous Electrode System

Pulse Biosciences, Inc. (Nasdaq: PLSE), a company leveraging its novel and proprietary CellFX Nanosecond Pulsed Field Ablation (nsPFA) technology, today announced the first procedure with the CellFX nsPFA Percutaneous Electrode System in the United States has been completed. The successful case is the first in the Company’s pilot program which follows the March 2024 U.S. FDA 510(k) clearance for the ablation of soft tissue in percutaneous and intraoperative surgical procedures with the system.

“I am very proud and excited that the first U.S. patient treatment with soft tissue ablation by the CellFX nsPFA system was performed this week in our Thyroid and Parathyroid Center here at Sarasota Memorial Hospital,” said Dr. Ralph P. Tufano, Medical Director, Head and Neck Endocrine Surgery for the Sarasota Memorial Health Care System in Sarasota, Florida. “The cell-specific mechanism of action of nsPFA allowed me to treat this patient with confidence, knowing that I was not going to cause collateral damage to acellular structures. The patient was treated for a large, symptomatic, benign, thyroid nodule in our office with just local lidocaine and tolerated the procedure extremely well, reporting no pain during nsPFA energy delivery, and is doing great. Based on the impressive results we have seen come out of Italy, I am confident the outcome of the procedure will be excellent. I am looking forward to continuing my collaboration with Pulse Biosciences to further refine the procedure and offer this life-changing new technology to my patients and to help to train other experts in this exciting new procedure.”

The CellFX nsPFA Percutaneous Electrode System consists of a percutaneous needle electrode for use with the Company’s proprietary CellFX nsPFA Console. Our proprietary and novel electrode is designed to harness and deliver the key advantages of nsPFA energy, enabling precise, nonthermal removal of cellular tissue without damage to noncellular structures or inducing thermal necrosis. This proprietary system is designed for non-cardiac applications.

“Treating our first patient under our newly FDA-cleared nsPFA percutaneous system is a fundamental and opportune milestone for Pulse Biosciences,” said Mitch Levinson, Chief Strategy Officer of Pulse Biosciences. “It is inspiring to see the difference our physicians can make in their patients’ lives with our unique proprietary technology, giving them the potential to set new standards for safety and efficacy as well as decreased workflow time from patient set-up to procedure finish. The administration of local anesthesia at the treatment site with the patient awake, without the need for general anesthesia, in cases to date, is a noteworthy positive. Team Pulse Biosciences is deeply grateful to Dr. Tufano for his partnership over the past 3 years. We are all looking forward to evolving the standard of medicine as together we optimize and introduce the CellFX nsPFA percutaneous procedure on a controlled and measured basis through the balance of 2024.”