Pulse Biosciences Reports Encouraging Six-Month PRECISE-BTN Study Results for nPulse Vybrance System in Benign Thyroid Nodules
Pulse Biosciences, Inc., a medical technology company developing its proprietary Nanosecond Pulsed Field Ablation™ (nano-PFA or nsPFA™) technology, has announced encouraging interim six-month clinical results from its PRECISE-BTN study. The prospective, multicenter U.S. clinical trial is evaluating the company’s nPulse™ Vybrance™ Percutaneous Electrode System for treating symptomatic and hyperfunctioning benign thyroid nodules (BTNs).
The latest findings were presented at the 95th Annual Meeting of the American Thyroid Association (ATA), held November 4–7, 2026, in Philadelphia, Pennsylvania. The interim analysis included 43 patients treated at three clinical centers in the United States who had completed the six-month assessment for the study’s primary endpoint.
The results demonstrated meaningful reductions in thyroid nodule volume, improvements in patient-reported quality of life and relief from symptoms associated with benign thyroid nodules. Specifically, 86% of patients achieved the primary endpoint of at least 50% nodule volume reduction at six months. The median reduction in nodule volume reached 72% during the same period.
The clinical findings also showed that improvements were evident relatively early following treatment, with most of the reduction in nodule volume already apparent at the one-month assessment. The reduction continued to improve through the six-month follow-up period.
In addition to the anatomical improvements, patients reported substantial improvements in quality of life. The ThyPRO-39 Overall Quality of Life Impact score improved by 78% from baseline at six months. Among patients who experienced neck pressure or fullness before treatment, the symptom had completely resolved in 82% of patients by the six-month assessment.
The interim safety findings were also encouraging, with no serious adverse events reported in the available dataset.
These results highlight the potential of Pulse Biosciences’ nonthermal nano-PFA technology as a minimally invasive treatment approach for appropriately selected patients with benign thyroid nodules. The company believes the technology could provide an alternative to conventional surgical procedures and thermal ablation techniques while helping preserve surrounding anatomical structures and thyroid function.
PRECISE-BTN Study Demonstrates Significant Thyroid Nodule Volume Reduction
The PRECISE-BTN study was designed to evaluate the performance and safety of the nPulse Vybrance Percutaneous Electrode System in patients with symptomatic and hyperfunctioning benign thyroid nodules.
Benign thyroid nodules are noncancerous growths that develop within the thyroid gland. Although many nodules do not cause noticeable symptoms or require treatment, some can increase in size and produce pressure-related symptoms, including difficulty swallowing, neck discomfort, visible swelling and a sensation of fullness in the throat.
Certain thyroid nodules may also become hyperfunctioning, meaning they produce excessive thyroid hormones independently of normal regulatory signals. This can contribute to hyperthyroidism and associated symptoms, including rapid heartbeat, nervousness, heat intolerance and other metabolic complications.
Treatment decisions depend on several factors, including nodule size, symptoms, thyroid hormone production and the patient’s overall health.
Traditional treatment approaches may include surgery, radioactive iodine therapy and minimally invasive procedures such as thermal ablation. However, some patients seek treatment alternatives that can reduce nodule size and associated symptoms while avoiding surgery and minimizing the risk of damaging surrounding structures.
The PRECISE-BTN study is investigating whether nanosecond pulsed field ablation can provide an effective and safe treatment option for this patient population.
In the interim six-month analysis, 86% of the 43 evaluated patients achieved at least a 50% reduction in thyroid nodule volume, meeting the study’s primary endpoint.
The median nodule volume reduction was 72% at six months, indicating a substantial reduction in the size of treated nodules across the evaluated patient population.
An additional observation was the timing of the treatment response. Most of the reduction in nodule volume was already evident by the one-month follow-up visit, with continued improvement observed over the following months.
The early appearance of treatment effects is an important finding because patients with symptomatic thyroid nodules may seek relief from pressure, discomfort and other problems associated with nodule enlargement.
The continued reduction through six months also provides preliminary evidence that the effects of treatment may develop progressively following the procedure.
Although these interim findings are encouraging, additional follow-up will be necessary to understand the durability of nodule volume reduction and evaluate longer-term treatment outcomes.
Significant Improvements in Quality of Life and Thyroid-Related Symptoms
In addition to measuring changes in thyroid nodule volume, the PRECISE-BTN study assessed patient-reported outcomes to understand how treatment affected daily life and symptom burden.
The interim results demonstrated a 78% improvement from baseline in the ThyPRO-39 Overall Quality of Life Impact score at six months.
ThyPRO-39 is a thyroid-specific patient-reported outcome instrument designed to evaluate the impact of thyroid disorders on patients’ physical, psychological and social well-being.
The assessment helps researchers understand how thyroid-related conditions affect everyday activities and overall health-related quality of life.
For patients with benign thyroid nodules, improvements in quality of life can be particularly important because symptoms may affect swallowing, breathing comfort, neck appearance and confidence in social situations.
The 78% improvement reported in the PRECISE-BTN interim dataset suggests that patients experienced meaningful benefits following treatment with the nPulse Vybrance System.
The study also evaluated the resolution of specific symptoms associated with thyroid nodules.
Among patients who reported neck pressure or fullness before receiving treatment, 82% experienced complete resolution of this symptom at the six-month assessment.
Neck pressure and fullness can occur when enlarged thyroid nodules exert pressure on surrounding tissues. These symptoms may interfere with normal activities and contribute to discomfort.
The high proportion of patients reporting complete resolution provides an additional indication of the potential clinical value of the treatment approach.
Together, the reductions in nodule volume and improvements in patient-reported outcomes suggest that the effects of nsPFA treatment may extend beyond changes in imaging measurements to include improvements in patients’ daily experiences.
Encouraging Safety Profile With No Serious Adverse Events Reported
Safety was another important component of the PRECISE-BTN study.
The interim six-month analysis reported no serious adverse events among the evaluated patients.
This finding is relevant because the thyroid gland is located in an anatomically sensitive area of the neck, close to several important structures, including nerves, blood vessels and the airway.
Procedures involving the thyroid therefore require careful consideration of potential complications and the preservation of surrounding tissues.
Traditional surgical approaches can be effective but may involve risks associated with anesthesia, incisions, scarring, postoperative recovery and potential injury to nearby structures.
Thermal ablation techniques offer minimally invasive alternatives for selected patients, but they rely on heat to destroy targeted tissue. Managing thermal energy near sensitive anatomical structures requires careful procedural planning.
Pulse Biosciences’ nsPFA technology uses ultra-short electrical energy pulses rather than heat to target cells within the treated tissue.
The company believes this nonthermal mechanism may provide an opportunity to selectively affect targeted cells while helping preserve adjacent structures.
The absence of serious adverse events in the current interim dataset provides encouraging preliminary safety information. However, the findings represent an interim analysis, and continued follow-up will be necessary to establish the broader safety profile of the procedure.
nPulse Vybrance System Uses Nonthermal Nanosecond Pulsed Field Ablation
The nPulse Vybrance Percutaneous Electrode System is based on Pulse Biosciences’ proprietary Nanosecond Pulsed Field Ablation technology.
The system delivers ultra-short bursts of electrical energy to targeted cells through a minimally invasive procedure performed under ultrasound guidance.
Unlike conventional thermal ablation technologies, which use heat to destroy unwanted tissue, nsPFA is designed to affect cells through electrical energy delivered over extremely short periods.
According to the company, this nonthermal approach is intended to clear targeted ablated cells while sparing adjacent acellular tissue.
This characteristic is important when treating thyroid nodules because the thyroid gland is surrounded by anatomical structures that perform essential functions.
Nearby nerves contribute to voice production and other important functions, while blood vessels supply the thyroid and surrounding tissues. Preserving these structures is a key consideration during thyroid interventions.
By using a nonthermal mechanism, Pulse Biosciences aims to provide physicians with an alternative approach for treating benign thyroid nodules while reducing the potential for heat-related injury to surrounding critical structures.
The procedure is performed using ultrasound guidance, which allows physicians to visualize the thyroid nodule and surrounding anatomy during treatment.
Ultrasound guidance is an important component of minimally invasive thyroid procedures because it helps clinicians position the electrode accurately and monitor the targeted treatment area.
The nPulse Vybrance System is designed to support treatment without requiring conventional surgical removal of the thyroid nodule.
Patients undergoing the procedure can generally return home on the same day, according to the company. The minimally invasive approach is intended to avoid surgical incisions and associated scarring while supporting a shorter recovery experience.
The company also reported that patients typically begin experiencing symptom relief within a few weeks following treatment.
The six-month PRECISE-BTN findings provide additional clinical information about the performance of this technology in patients with symptomatic and hyperfunctioning benign thyroid nodules.
Investigators Highlight Potential Benefits for Patients
Clinical investigators involved in the PRECISE-BTN study expressed optimism about the interim findings, particularly the observed reductions in nodule volume, improvements in quality of life and safety results.
Ralph Tufano, MD, Director of the Multidisciplinary Thyroid and Parathyroid Center at Sarasota Memorial Hospital and principal investigator of the PRECISE-BTN study, presented the data at the American Thyroid Association’s 95th Annual Meeting.
Tufano described the six-month findings as encouraging, emphasizing that reductions in thyroid nodule volume were already apparent within the first month and continued through the six-month assessment.
He also highlighted the improvements experienced by patients in terms of symptoms and quality of life.
According to Tufano, the findings were particularly meaningful for patients with hyperfunctioning thyroid nodules, where improvements in thyroid hormone levels alongside preservation of thyroid function are important treatment considerations.
He noted that the research team looks forward to evaluating the 12-month results to gain further information about treatment outcomes over a longer period.
Thomas Fahey, MD, an investigator at Weill Cornell Medicine, also highlighted the significance of the interim results.
Fahey noted the encouraging findings across both symptomatic and hyperfunctioning thyroid nodules, while emphasizing the available safety profile associated with nsPFA treatment.
He described a nonthermal, ultrasound-guided treatment approach that can be used around nerves and other critical anatomical structures as a potentially meaningful addition to available treatment options for appropriately selected patients.
Kepal Patel, MD, an investigator at NYU Langone Health, emphasized the importance of providing patients with treatment alternatives that can address thyroid nodule symptoms without requiring surgery.
Patel explained that many patients seek options that can reduce symptoms while minimizing the risk of affecting normal thyroid function.
He noted that the interim PRECISE-BTN findings were encouraging in both areas, highlighting the potential value of the technology for patients seeking less invasive treatment approaches.
The investigators’ comments reflect the clinical interest in developing alternatives that can address benign thyroid nodules while considering patient comfort, treatment effectiveness and preservation of surrounding thyroid function.
Company Leadership Highlights Progress Toward Clinical Validation
Paul LaViolette, CEO and Co-Chairman of Pulse Biosciences, emphasized that the PRECISE-BTN study was designed to determine whether the findings from the company’s earlier feasibility work could be reproduced in a rigorous, prospective, multicenter clinical setting.
He described the six-month interim results as an encouraging step toward achieving that objective.
LaViolette highlighted the safety findings and the treatment outcomes observed across patients with both symptomatic and hyperfunctioning nodules.
He also acknowledged the contributions of the investigators, participating clinical centers and patients involved in the study.
The company’s leadership believes that demonstrating consistent results in a prospective multicenter setting is an important part of establishing the clinical potential of its proprietary technology.
Early feasibility studies can provide initial evidence about the performance of a medical device or treatment approach. However, larger and more structured clinical evaluations are necessary to assess whether those findings can be reproduced across different clinical settings and patient populations.
The PRECISE-BTN study is intended to provide this additional evidence.
Pulse Biosciences stated that it looks forward to reporting the complete results once all enrolled patients have completed their six-month follow-up assessments.
PRECISE-BTN Follow-Up Continues With 12-Month Results Expected
The PRECISE-BTN clinical study remains ongoing, with additional follow-up assessments planned to evaluate the durability of treatment effects and provide a more comprehensive understanding of the technology’s clinical performance.
The currently reported interim dataset includes 43 patients from three U.S. centers who had reached the six-month primary endpoint assessment.
The company expects to report six-month data for all patients enrolled in the study as they complete the required follow-up period.
In addition, 12-month results are expected to become available as follow-up activities are completed.
The upcoming data will be important for evaluating whether the reductions in nodule volume observed at six months are maintained over time.
Longer-term follow-up may also provide additional information about symptom resolution, quality of life, thyroid function and the occurrence of potential adverse events.
For patients with hyperfunctioning nodules, continued assessment of thyroid hormone levels and thyroid function will be particularly relevant in understanding the broader clinical benefits of the procedure.
The company has not yet reported the complete six-month dataset or final 12-month outcomes.
The preliminary six-month findings from the PRECISE-BTN study represent an important clinical milestone for Pulse Biosciences as it continues evaluating its nPulse Vybrance Percutaneous Electrode System.
The interim results showed that 86% of evaluated patients achieved at least 50% nodule volume reduction, with a median reduction of 72% at six months. Patients also experienced a 78% improvement in the ThyPRO-39 Overall Quality of Life Impact score, while neck pressure or fullness completely resolved in 82% of affected patients.
The absence of serious adverse events in the interim dataset further supports continued investigation of the nonthermal treatment approach.
The findings were presented at the 95th Annual Meeting of the American Thyroid Association, providing an opportunity to share emerging clinical evidence with the thyroid research and medical community.
As follow-up continues, the company expects additional six-month data covering all study participants, followed by 12-month results.
These upcoming findings will help determine the durability of nodule volume reduction, the longer-term impact on symptoms and thyroid function, and the overall safety profile of the procedure.
Through the PRECISE-BTN study, Pulse Biosciences aims to establish the clinical potential of its proprietary nano-PFA technology and expand minimally invasive treatment possibilities for patients with benign thyroid nodules.
About the PRECISE-BTN Study
The PRECISE-BTN study is a prospective, single-arm, multicenter clinical investigation designed to evaluate the safety and effectiveness of the nPulse™ Vybrance™ Percutaneous Electrode System using nsPFA energy for the treatment of symptomatic benign thyroid nodules.
The study completed 100 patient enrollment at three U.S. centers, including principal investigator Ralph Tufano, MD, of Sarasota Memorial Health Care System in Sarasota, Florida, investigator Kepal Patel, MD, of NYU Langone Health in New York, and investigators Thomas Fahey, MD, and Brendan Finnerty, MD, of Weill Cornell Medicine. Patients are followed at 1, 3, 6, and 12 months post-procedure. The primary endpoint is nodule volume reduction of at least 50% at six months; additional endpoints include safety, symptomatic relief, hormone normalization, and improvements in quality of life.
About Pulse Biosciences®
Pulse Biosciences is a novel bioelectric medicine company committed to health innovation that has the intention as well as potential to improve the quality of life for patients. The Company’s proprietary nPulse™ technology delivers nanosecond pulses of electrical energy to non-thermally clear cells while sparing adjacent non-cellular tissue. The Company is actively pursuing the development of its nPulse technology for use in the treatment of atrial fibrillation and in a select few other markets where it could have a profound positive impact on healthcare for both patients and providers.
Pulse Biosciences, nPulse, Vybrance, CellFX, Nano-Pulse Stimulation, NPS, nsPFA, CellFX nsPFA and the stylized logos are among the trademarks and/or registered trademarks of Pulse Biosciences, Inc. in the United States and other countries.