Pulse Biosciences enrolls first patients in thyroid cancer study
Pulse Biosciences Inc. (NASDAQ: PLSE) announced the enrollment of the first patients in a feasibility study evaluating its nPulse Vybrance Percutaneous Electrode System for treating papillary thyroid microcarcinoma. The initial procedures were completed at Sarasota Memorial Health Care System in Florida and The University of Texas MD Anderson Cancer Center in Houston.
The multicenter study will evaluate the safety and effectiveness of the system in treating papillary thyroid cancer tumors smaller than 1.5 cm. The company plans to enroll 30 patients across two study sites. The first patient was treated by Dr. Ralph P. Tufano at Sarasota Memorial, while Dr. Victoria Banuchi, the principal investigator, completed two subsequent cases at UT MD Anderson.
The nPulse system uses nanosecond pulsed field ablation technology, which the company describes as a nonthermal approach. The system previously received FDA 510(k) clearance for soft tissue ablation and is being evaluated under an Investigational Device Exemption 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, Director of the Multidisciplinary Thyroid and Parathyroid Center at Sarasota Memorial.
Paul LaViolette, Co-Chairman and CEO of Pulse Biosciences, stated that the nonthermal mechanism positions the technology as a potential treatment option for both benign and malignant thyroid tumors.
The study targets T1N0M0 papillary thyroid microcarcinoma, described as a small, slow-growing form of thyroid cancer. The information is based on a company press release.
