Pulse Biosciences Reports First U.S. Use of CellFX nsPFA Electrode System

Pulse Biosciences, Inc. (Nasdaq: PLSE), based in Hayward, California, has pioneered a groundbreaking medical procedure using its unique CellFX® Nanosecond Pulsed Field Ablation™ (nsPFA™) technology. This innovative system saw its first use in a U.S. medical procedure, following the FDA's 510(k) clearance in March 2024 for the ablation of soft tissue in percutaneous and intraoperative surgeries.

The inaugural procedure took place at Sarasota Memorial Hospital, specifically in the Thyroid and Parathyroid Center. Dr. Ralph P. Tufano, who serves as the Medical Director of Head and Neck Endocrine Surgery at Sarasota Memorial Health Care System, led the procedure. Dr. Tufano expressed his enthusiasm, highlighting the precision and confidence the nsPFA technology provided. It allowed him to treat a patient with a significant benign thyroid nodule effectively, using only local anesthesia. The patient reportedly felt no pain during the procedure and showed promising recovery signs.

The CellFX nsPFA Percutaneous Electrode System is built around a percutaneous needle electrode, designed to work in tandem with the CellFX nsPFA Console. This proprietary system enables precise, nonthermal removal of cellular tissue, ensuring no damage to noncellular structures or causing thermal necrosis. The technology is intended for non-cardiac applications.

Mitch Levinson, Chief Strategy Officer at Pulse Biosciences, emphasized the significance of this milestone. He praised the potential of their proprietary technology to set new standards in medical safety and efficiency. Levinson also noted the practical benefits, such as the use of local anesthesia and the reduced procedural time from patient setup to completion. He expressed gratitude towards Dr. Tufano for his collaboration over the past three years and looked forward to further refining and introducing this technology on a broader scale throughout 2024.

Between April 2023 and January 2024, the CellFX nsPFA Percutaneous System was utilized in Italy for thyroid nodule ablation in 30 patients. Follow-up evaluations were conducted from as early as one week and up to 180 days post-procedure. These assessments demonstrated no scarring or injury to surrounding tissues, indicating successful outcomes for all treated patients.

Pulse Biosciences is a company dedicated to advancing bioelectric medicine. Their CellFX nsPFA technology delivers nanosecond electrical pulses to non-thermally ablate cells, preserving adjacent noncellular tissues. The company is actively working on expanding the applications of this technology to treat various conditions, including atrial fibrillation, and aims to have a substantial impact on healthcare for patients and providers alike.

Pulse Biosciences' commitment to innovation and improving patient care is evident through their continuous efforts in developing and refining their proprietary technologies. The successful implementation of their CellFX nsPFA system marks a significant step forward in medical treatments, offering a promising alternative for soft tissue ablation procedures.