On March 12, 2026 Pulse Biosciences, Inc. (Nasdaq: PLSE), developer of the novel nPulse technology using its proprietary Nanosecond Pulsed Field Ablation (nanosecond PFA or nsPFA) energy, reported 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.
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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.
"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."
"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 important initial step and is consistent with our mission to rigorously generate data and demonstrate the potential to improve patient outcomes and provide clinicians with more precise, tissue-sparing tools for minimally invasive treatment applications."
About the Company’s nPulse Vybrance Percutaneous Electrode System
The Company’s nPulse Vybrance Percutaneous Electrode System consists of a percutaneous needle electrode for use with the Company’s proprietary nPulse Console. The 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. The system has received U.S. Food and Drug Administration (FDA) 510(k) clearance for use in the ablation of soft tissue in percutaneous and intraoperative surgical procedures. This proprietary system is designed for non-cardiac applications.
(Press release, Pulse Biosciences, MAR 12, 2026, View Source [SID1234663505])