PULSE BIOSCIENCES, INC.

Key study findings include:

These long-term benefits manifest the uniqueness of nsPFA as differentiated 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.

“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 Prof. 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.”

This study is an extension of the initial feasibility study conducted by Prof. Spiezia at Ospedale del Mare in Naples, Italy, which evaluated nsPFA energy for the treatment of benign thyroid nodules. The study was extended to allow for long-term follow-up of a subset of the patients included in the initial study. A total of 21 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. 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. Ours 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.”