Pulse Biosciences Begins First Human Study Of New Device To Treat Small Thyroid Cancer Tumors

Pulse Biosciences, Inc. (NASDAQ:PLSE), developer of the novel nPulse™ technology using its proprietary Nanosecond Pulsed Field Ablation™ (nanosecond PFA or nsPFA™) energy, today announced first patient enrollments in the multi-center first-in-human feasibility study of the Company's nPulse™ Vybrance™ Percutaneous Electrode System for treatment of T1N0M0papillary thyroid microcarcinoma (PTM), a small, slow-growing, and most common form of thyroid cancer. The initial procedures were successfully completed at Sarasota Memorial Health Care System in Sarasota, Florida, and The University of Texas MD Anderson Cancer Center in Houston, Texas.

The multicenter, prospective feasibility study is designed to evaluate the safety and effectiveness of the nPulse™ Vybrance™ Percutaneous Electrode System in treating papillary thyroid cancer tumors less than 1.5 cm in size. A total of 30 patients are planned for enrollment between two study sites. The first patient was enrolled and treated by Ralph P. Tufano, MD, Director of the Multidisciplinary Thyroid and Parathyroid Center at Sarasota Memorial, while two subsequent cases were completed by Principal Investigator, Dr. Victoria Banuchi, Associate Professor of Head & Neck Surgery at UT MD Anderson. The system previously received U.S. Food and Drug Administration (FDA) 510(k) clearance for the ablation of soft tissue and is now being evaluated under an Investigational Device Exemption (IDE) specifically for thyroid cancer applications.