Pulse Biosciences Reaches Full Enrollment in Thyroid Nodule Treatment Study

Key Points

• Pulse Biosciences completed enrollment of 100 patients in its PRECISE-BTN clinical study.
• The study is evaluating the nPulse™ Vybrance™ Percutaneous Electrode System for symptomatic benign thyroid nodules.
• The first enrolled patient completed the final 12-month follow-up visit in August.
• Enrollment was completed across three U.S. medical centers in about 12 months.
• Pulse Biosciences plans to present preliminary study data at an upcoming medical conference, with full results expected after all patients complete 12-month follow-up.

Pulse Biosciences (NASDAQ: PLSE) has completed enrollment in its PRECISE-BTN clinical study, which is evaluating the company’s nPulse Vybrance Percutaneous Electrode System for people with symptomatic benign thyroid nodules.

The study enrolled 100 patients across three U.S. sites. Pulse Biosciences also said the first patient enrolled has completed the study’s final 12-month follow-up visit.

PRECISE-BTN Study Enrollment Doubled From Original 50-Patient Plan

Pulse Biosciences initially designed PRECISE-BTN as a 50-patient study before expanding enrollment to 100 patients.

The company said it enrolled all 100 patients across Sarasota Memorial Health Care System in Florida, NYU Langone Health in New York, and Weill Cornell Medicine in New York. Enrollment was completed in approximately 12 months.

The expanded enrollment may provide the company with a larger set of patient results to assess the performance of the nPulse Vybrance system.

nPulse Vybrance Uses Nanosecond Pulsed Field Ablation Energy

The nPulse Vybrance Percutaneous Electrode System uses Pulse Biosciences’ proprietary Nanosecond Pulsed Field Ablation, or nsPFA, energy.

The system is being studied as a treatment for symptomatic benign thyroid nodules. These are noncancerous growths in the thyroid gland that can cause symptoms.

The PRECISE-BTN study is prospective, meaning patients are followed forward over time after receiving the procedure. It is also a single-arm study, meaning the release does not describe a separate control or comparison group.

Study Tracks Nodule Size, Symptoms, Hormone Levels and Quality of Life

Patients in PRECISE-BTN are evaluated at one, three, six, and 12 months after treatment.

The study is designed to assess safety and effectiveness. Its endpoints include treatment safety, reduction in the size of the targeted thyroid nodule, symptom relief, hormone normalization, and changes in quality of life.

The first procedures were performed at Sarasota Memorial Health Care System under principal investigator Ralph P. Tufano, MD, MBA, FACS. Other participating investigators include Kepal N. Patel, MD at NYU Langone Health, along with Thomas J. Fahey III, MD and Brendan M. Finnerty, MD at Weill Cornell Medicine.

Preliminary Data Presentation Is Planned Before Full 12-Month Results

Pulse Biosciences said it plans to present preliminary PRECISE-BTN data at an upcoming medical society conference.

The company expects full results after every enrolled participant completes 12 months of follow-up. The announcement does not provide a specific date for the preliminary presentation or full data release.