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New clinical findings from Pulse Biosciences highlight encouraging long-term outcomes for its nPulse Vybrance Percutaneous Electrode System in the treatment of benign thyroid nodules. The results, presented at the North American Society for Interventional Thyroidology 2026 Meeting in Portland, Oregon, demonstrate sustained reductions in nodule volume and strong patient satisfaction more than a year after treatment.
The first-in-human feasibility study evaluated the use of the company’s proprietary Nanosecond Pulsed Field Ablation (nsPFA) energy. Unlike thermal ablation techniques that rely on heat, nsPFA uses extremely short bursts of electrical energy to target cellular structures while preserving surrounding non-cellular tissue.
The extended follow-up from the study examined durability of outcomes between 15 and 22 months after treatment. Researchers reported an average reduction of 74 percent in the volume of treated benign thyroid nodules, with continued improvement observed from the first month through the final follow-up period.
Importantly, investigators noted that none of the treated nodules showed regrowth during the monitoring period. Ultrasound imaging also showed no evidence of intranodular fibrosis, and no serious adverse events were reported among the study participants.
Patient-reported outcomes further reinforced the findings. At the final follow-up, all patients reported being highly satisfied with the cosmetic appearance following treatment, while 95 percent reported high overall satisfaction.
These outcomes, researchers noted, may reflect distinctive characteristics of nanosecond pulsed field ablation. Compared with other forms of pulsed field energy ablation, nsPFA involves extremely rapid particle flow and high voltage delivered within very short time intervals.
“These long-term data from the initial feasibility study provide an early view into the potential of nPulse Vybrance for the durable ablation of benign thyroid nodules. Within this feasibility study we were able to demonstrate significant volume reduction, without regrowth or serious adverse events out to 15 to 22 months. Of the patients treated in this study, 100 percent were highly satisfied with their cosmetic appearance, and 95 percent were highly satisfied with their overall treatment, which is encouraging given the duration of follow-up in this feasibility study,” said Stefano Spiezia, Chief of Endocrine Surgery at Ospedale del Mare.
“This study provides the foundation for future research in using nsPFA energy, a highly differentiated nonthermal energy source, for the treatment of benign thyroid nodules. In the future, with continued data to support, I see nsPFA energy emerging as a potential nonthermal paradigm in the treatment of benign thyroid nodules.”
The research builds on an initial feasibility study conducted at Ospedale del Mare in Naples, where nsPFA energy was first evaluated for treating benign thyroid nodules. For the extended follow-up phase, a subset of patients from the original study cohort continued to be monitored to assess long-term durability.
In total, 21 patients were observed between 15 and 22 months to evaluate changes in nodule volume over time.
“These data on initial feasibility and clinical durability demonstrated significant progress in the development of clinical evidence for the use of nsPFA energy for the ablation of benign thyroid nodules. While the work to establish clinical outcomes of nPulse Vybrance for benign thyroid nodules is early, these data provide the first long-term results of sustained tissue responses. Evidence of sustainable volume reduction and high patient satisfaction, added to the inherent procedural safety and soft tissue response of nsPFA ablation, provide promising signals to pursue in our future market development work. Our plans for non-cardiac nsPFA will be made clearer in the second half of 2026,” said Paul LaViolette, CEO and Co-Chairman of Pulse Biosciences.
“We extend our highest gratitude to Professor Stefano Spieza and our clinical investigators who continue to lead this important clinical work.”
While the research remains at an early stage, the findings add to ongoing discussions around non-thermal approaches to soft-tissue ablation. For patients with benign thyroid nodules, who may seek treatment due to symptoms or cosmetic concerns, the results suggest a potential path toward durable outcomes with a different energy modality than those traditionally used in ablation procedures.
Following the success of its Middle East flagship event, MedTech World is now heading to Florida for MedTech World North America, taking place in West Palm Beach from 11 to 13 May 2026.
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