Pulse Biosciences completes 100-patient thyroid nodule study enrollment

Pulse Biosciences, Inc. (Nasdaq: PLSE) announced two milestones in its PRECISE-BTN clinical study evaluating the nPulse Vybrance Percutaneous Electrode System for the treatment of symptomatic benign thyroid nodules.

The company completed enrollment of 100 patients in August, double the study's original 50-patient design. Enrollment was conducted across three U.S. sites — Sarasota Memorial Health Care System, NYU Langone Health, and Weill Cornell Medicine — over approximately 12 months.

Separately, the first patient enrolled in the study completed the final 12-month follow-up visit in August at Sarasota Memorial Health Care System in Sarasota, Florida, under the supervision of Ralph P. Tufano, MD, MBA, FACS.

The PRECISE-BTN study is a prospective, single-arm, multicenter investigation designed to evaluate the safety and effectiveness of the nPulse Vybrance system using nanosecond Pulsed Field Ablation energy. Study endpoints include safety, nodule volume reduction, symptomatic relief, hormone normalization, and quality-of-life improvements. Patients are followed at 1, 3, 6, and 12 months post-procedure.

Pulse Biosciences said it plans to present preliminary study data at an upcoming medical society conference, with full data expected upon completion of 12-month follow-up for all enrolled patients.

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