Pulse Biosciences Begins nPulse Study for Malignant Thyroid Tumor Treatment

Pulse Biosciences Inc. has enrolled the first patients in a first-in-human feasibility study of its nPulse™ Vybrance Percutaneous Electrode System for treating 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, Fla., and The University of Texas MD Anderson Cancer Center in Houston.

The multicenter, prospective feasibility study is evaluating the safety and effectiveness of the nPulse Vybrance Percutaneous Electrode System in treating papillary thyroid cancer tumors smaller than 1.5 cm. Administrators plant to enroll 30 patients between two study sites. The first patient was enrolled and treated by Ralph P. Tufano, M.D., 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.

“Enrolling our first patient marks an important initial milestone in potentially expanding treatment options for patients with low-risk thyroid cancer,” Dr. Tufano said. “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.”

The nPulse Vybrance system has received U.S. Food and Drug Administration (FDA) 510(k) clearance for soft tissue ablation and is now being evaluated under an Investigational Device Exemption (IDE) specifically for thyroid cancer applications.

“We believe the non-thermal mechanism of action of nsPFA positions our nPulse technology as a potential treatment option for both benign and malignant thyroid tumors,” Pulse Biosciences Co-Chairman/CEO Paul LaViolette stated. “Commencing these first-in-human feasibility cases in collaboration with 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.”

Pulse Biosciences’ nPulse Vybrance Percutaneous Electrode System consists of a percutaneous needle electrode for use with the company’s proprietary nPulse Console. The electrode harnesses and delivers the key advantages of Nanosecond Pulsed Field Ablation (nsPFA) energy, enabling precise, non-thermal removal of cellular tissue without damage to noncellular structures or inducing thermal necrosis. This proprietary system is designed for non-cardiac applications.

Pulse Biosciences is a bioelectric medicine company whose proprietary nPulse technology delivers nanosecond pulses of electrical energy to non-thermally clear cells while sparing adjacent noncellular tissue. The company is actively pursuing the development of its nPulse technology for use in treating atrial fibrillation and in a select few other markets where it could impact healthcare for both patients and providers, such as surgical soft tissue ablation.