HAYWARD, Calif. — September 15, 2026
Pulse Biosciences, Inc. announced completion of enrollment in the PRECISE-BTN clinical study evaluating the nPulse™ Vybrance™ Percutaneous Electrode System for symptomatic benign thyroid nodules. The company enrolled 100 patients across three U.S. clinical sites, doubling the study’s original 50-patient enrollment target. Enrollment was completed in approximately 12 months at Sarasota Memorial Health Care System, NYU Langone Health and Weill Cornell Medicine. Pulse also reported that the first patient enrolled in the study completed the final 12-month follow-up visit in August 2026, marking an additional milestone for the clinical program. The study is evaluating the safety and effectiveness of nanosecond Pulsed Field Ablation (nsPFA™) energy as a potential minimally invasive treatment approach for symptomatic benign thyroid nodules.
PRECISE-BTN Evaluates nPulse Vybrance System
The prospective, single-arm, multicenter PRECISE-BTN study is designed to evaluate the nPulse Vybrance Percutaneous Electrode System in patients with symptomatic benign thyroid nodules. Participants undergo follow-up assessments at 1, 3, 6 and 12 months after treatment, with study endpoints covering safety, targeted nodule-volume reduction, symptom relief, hormone normalization and quality-of-life improvements. The program is being conducted at three U.S. centers, with procedures performed at Sarasota Memorial Health Care System and additional participation from NYU Langone Health and Weill Cornell Medicine. Pulse expanded the study from its original 50-patient design to 100 patients, providing a larger clinical dataset for evaluating the technology. The completion of enrollment allows the company to move toward the next stage of data analysis while patients continue through their scheduled follow-up assessments.
Nanosecond PFA Targets Non-Thermal Tissue Ablation
Pulse Biosciences is developing the nPulse technology as a bioelectric medicine platform that delivers nanosecond pulses of electrical energy to targeted cells while sparing adjacent non-cellular tissue. Unlike conventional thermal ablation approaches, the company’s Nanosecond Pulsed Field Ablation technology is designed to produce non-thermal cellular effects. In the PRECISE-BTN program, the nPulse Vybrance system is being evaluated for its ability to treat benign thyroid nodules while potentially addressing symptoms and reducing targeted nodule volume. The company’s broader development strategy includes applications in atrial fibrillation and surgical soft-tissue ablation, giving the technology potential utility across multiple medical applications. However, the thyroid program remains investigational, and the ongoing 12-month follow-up will be important for establishing the safety and effectiveness profile of the system.
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Pulse Biosciences Moves Toward Clinical Data Readout
With all 100 patients enrolled, Pulse Biosciences is preparing for the next major milestone in the PRECISE-BTN program: clinical data reporting. The company plans to present preliminary findings at an upcoming medical society conference, while full data are expected after all enrolled patients complete their 12-month follow-up. The expanded enrollment provides a broader evidence base across three U.S. clinical sites and enables assessment of both short- and longer-term outcomes through the study’s scheduled evaluations. For Pulse Biosciences, completion of enrollment also represents progress in advancing its proprietary nPulse platform toward potential clinical applications beyond its existing development programs. As the PRECISE-BTN cohort moves through final follow-up, the company is positioning the resulting safety, nodule-reduction, symptom and quality-of-life data to guide the next stage of development for nsPFA-based treatment of symptomatic benign thyroid nodules.
Source: Pulse Biosciences press release
