Pulse Biosciences (Nasdaq:PLSE) today announced the publication of first-in-human feasibility study results for its pulsed field ablation (PFA) technology.
Dr. Stefano Spiezia conducted the study at the Ospedale del Mare Center in Naples, Italy. It evaluated the effectiveness of the company’s nanosecond pulsed field ablation (nsPFA) in benign thyroid nodules. Investigators published findings in the journal Thyroid.
The study sought to assess the ability of nsPFA energy to provide a safe and effective option for treating symptomatic benign thyroid nodules with minimal side effects. Investigators used Pulse Biosciences’ CellFX percutaneous electrode system under ultrasound guidance to ablate nodules. They performed either isolated ablations to assess tissue response or for full treatment of thyroid nodules with therapeutic intent.
Results showed no intranodular fibrosis or scarring on follow-up ultrasounds. Fully-treated nodules had up to 93% reduction in size at one year on ultrasound assessment, averaging 86% reduction. The study also demonstrated symptom relief and greater than 48% reduction as early as two weeks.
“We are very proud to have this data published in a leading scientific journal in the field, the renowned Journal Thyroid. The results of this study are extremely compelling and demonstrate nsPFA’s ability to offer advantages in treating benign thyroid nodules compared to other methods such as thyroidectomy or thermal ablation. This technology provides a favorable safety profile, rapid symptom reduction, and lack of internodular fibrosis and scarring,” said Spiezia. “These benefits are very appealing to surgeons who always prioritize generating consistent positive outcomes for their patients with increased safety and effectiveness.”
