Pulse Biosciences, Inc. announced on September 15, 2026, that it has completed patient enrollment in the PRECISE-BTN clinical study. The study is evaluating the company's nPulse Vybrance Percutaneous Electrode System for the treatment of symptomatic benign thyroid nodules (BTNs).
The enrollment effort expanded the study from an original design of 50 patients to a total of 100 patients. All patients were enrolled across three clinical sites in the United States: Sarasota Memorial Health Care System, NYU Langone Health, and Weill Cornell Medicine. The enrollment process was completed in approximately 12 months.
The Company reported that the first patient enrolled in the study completed their final 12-month follow-up visit in August. The study protocol mandates follow-up visits at one, three, six, and twelve months post-procedure. The primary endpoints of the study include safety, targeted nodule volume reduction, symptomatic relief, hormone normalization, and improvements in quality of life.
Investigators participating in the study include Ralph P. Tufano, MD, MBA, FACS at Sarasota Memorial Health Care System; Kepal N. Patel, MD at NYU Langone Health; and Thomas J. Fahey III, MD and Brendan M. Finnerty, MD at Weill Cornell Medicine.
Pulse Biosciences stated that it plans to present preliminary data from the PRECISE-BTN study at an upcoming medical society conference. Full data is expected to be available upon the completion of the study's 12-month follow-up for all patients.
