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Pulse Biosciences, Inc. Announces First Enrollments in Feasibility Study for the Treatment of Malignant Thyroid Tumors with nPulse™ Technology
HAYWARD, Calif.--(BUSINESS WIRE)-- Pulse Biosciences, Inc. (Nasdaq: PLSE), developer of the novel nPulse™ technology using its proprietary Nanosecond Pulsed
About this update from Pulse Biosciences, Inc
[{"type":"text","content":" HAYWARD, Calif.--(BUSINESS WIRE)--\nPulse 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 T1N0M0 papillary 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.\n\n\nThe 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.\n\n\n\"Enrolling our first patient marks an important initial milestone in potentially expanding treatment options for patients with low-risk thyroid cancer,\" said Dr. Tufano. \"Findings from this study may help determine whether nsPFA technology could offer a safe and effective alternative to surgery or serial surveillance for select patients by providing a minimally invasive, nonthermal approach that spares critical surrounding structures.\"\n\n\n“We believe the nonthermal mechanism of action of nsPFA positions our nPulse technology as a potential treatment option for both benign and malignant thyroid tumors,” said Paul LaViolette, Co-Chairman and CEO of Pulse Biosciences. “Commencing these first-in-human feasibility cases in collaboration with world-class institutions like UT MD Anderson and Sarasota Memorial is an imp...