Pulse Biosciences, Inc. (PLSE), a bioelectric medicine company, announced first patient enrollments in the feasibility study of its nPulse Vybrance Percutaneous Electrode System for the treatment of T1N0M0 papillary thyroid microcarcinoma.
Pulse Biosciences' nPulse Vybrance Percutaneous Electrode System consists of a percutaneous needle electrode for use with the firm's proprietary nPulse Console. The electrode is designed to deliver the key advantages of nanosecond Pulsed Field Ablation (nsPFA) energy, enabling precise, nonthermal removal of cellular tissue without damaging noncellular structures or inducing thermal necrosis.
The feasibility study is multi-centre and first-in-human, designed to evaluate the safety and effectiveness of the nPulse Vybrance Percutaneous Electrode System in treating papillary thyroid cancer tumours measuring less than 1.5 cm. A total of 30 patients are planned for enrollment between two study sites. T1N0M0 papillary thyroid microcarcinoma (PTM) is the most common form of thyroid cancer, a small, slow-growing tumour.
The initial procedures were successfully completed at Sarasota Memorial Health Care System in Sarasota, Florida, and the University of Texas MD Anderson Cancer Centre in Houston, Texas.
The first patient was enrolled and treated by Ralph P. Tufano at Sarasota Memorial, while two subsequent cases were completed by Victoria Banuchi at UT MD Anderson.
Notably, the nPulse Vybrance Percutaneous Electrode 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.
Also, the firm is actively pursuing the development of its nPulse technology for the treatment of atrial fibrillation and, in select other markets, such as surgical soft-tissue ablation.
"We believe the nonthermal mechanism of action of nsPFA positions our nPulse technology as a potential treatment option for both benign and malignant thyroid tumours," said Paul LaViolette, Co-Chairman and CEO of Pulse Biosciences.
PLSE has traded between $12.56 and $26.30 in the last year. The stock closed Thursday's trade at $21.30, up 6.45%.
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