Pulse Biosciences Announces Clinical Data From nPulse Vybrance System Study

Pulse Biosciences Inc. is sharing clinical data on outcomes durability from the nPulse Vybrance Percutaneous Electrode System First-in-Human ablation study of benign thyroid nodules using nsPFA energy.

The long-term follow-up from this study demonstrates significant and sustained volume reduction of treated benign thyroid nodules at 15 to 22 months, with no tissue regrowth and no serious adverse events.

Key study findings include:

• Durable 15 to 22 month results with an average 74% volume reduction of treated benign thyroid nodules with overwhelming patient satisfaction reported
• Continued volume reduction improvements from one month through 22 months
• No regrowth of nodules at 15 to 22 months
• Patient-reported cosmetic satisfaction: 100% were highly satisfied at final follow-up
• Patient-reported overall satisfaction: 95% were highly satisfied at final follow-up
• No serious adverse events
• No intranodular fibrosis detected on ultrasounds at 15 to 22 months
• Potential for clinical durability of benign thyroid ablation

These long-term benefits shows the uniqueness of nsPFA from all other present forms of Pulse Field Energy Ablation, namely the speed of particle flow as well as the absolute voltage pressure per unit of time, the company claims.

“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,” said Prof. Stefano Spiezia, chief of Endocrine Surgery at Ospedale del Mare (Naples, Italy). “Of the patients treated in this study, 100% were highly satisfied with their cosmetic appearance, and 95% were highly satisfied with their overall treatment, which is encouraging given the duration of follow-up in this feasibility study. 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.”

This study is an extension of the initial feasibility study Spiezia conducted at Ospedale del Mare, which evaluated nsPFA energy in treating benign thyroid nodules. The study was extended to allow for long-term follow-up of a patient subset included in the initial study. Twenty-one patients were subsequently monitored between 15 and 22 months to evaluate volume reduction trends 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,” Pulse Biosciences Co-Chairman/CEO Paul LaViolette stated. “Evidence of sustainable volume reduction and high patient satisfaction, added to the inherent procedural safety and soft tissue response of nsPFA ablation, provides 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. We extend our highest gratitude to Professor Stefano Spieza and our clinical investigators who continue to lead this work.”

Pulse Biosciences is a bioelectric medicine company whose proprietary nPulse technology delivers nanosecond pulses of electrical energy to non-thermally clear cells while sparing adjacent noncellular tissue. The company is actively developing its nPulse technology for treating atrial fibrillation and other conditions in which it could have a profound positive impact on healthcare for both patients and providers, such as surgical soft tissue ablation.