Pulse Biosciences Announces Positive Clinical Data Presented at the American Thyroid Association
European feasibility study demonstrates using nano-PFA in benign thyroid nodules reduces nodule volume by greater than 50% and provides symptomatic relief within the first month of treatment
The preliminary data demonstrate that nano-PFA pulses effectively delivered by the Company’s Percutaneous Electrode System reduced nodule sizes on average by over 50%, without evidence of residual fibrosis or scarring, and provided symptomatic relief within the first month of treatment. The nonthermal and minimally invasive nature of nano-PFA energy has shown potential to mitigate the risk of complications from thermal ablation procedures or surgical removal of benign thyroid nodules.
“I am proud to report that in the treated nodules, we observed significant nodule volume reductions which led to great improvements in symptoms for the patients in our study. We are excited to finish the long-term follow-up, complete the study, and continue the utilization of nano-PFA to advance the standard of care for patients with benign thyroid nodules,” said Dr.
Pulse Biosciences’ nsPFA Percutaneous Electrode System is currently being investigated by
“These groundbreaking results suggest nano-PFA energy can provide symptomatic relief to patients with benign thyroid nodules across the first month after the treatment,” said
About Percutaneous Electrode System
The Percutaneous Electrode System consists of a percutaneous needle electrode for use with the Company’s proprietary nano-PFA Console. The proprietary and novel electrode is designed to harness and deliver the key advantages of nano-PFA energy, enabling precise, nonthermal removal of cellular tissue without damage to noncellular structures or inducing thermal necrosis. The system has received
About Pulse Biosciences®
Forward-Looking Statements
All statements in this press release that are not historical are forward-looking statements, including, among other things, statements relating to the effectiveness of the Company’s CellFX nsPFA technology and CellFX System to safely and effectively provide symptomatic relief to patients with benign thyroid nodules or cause significant nodule volume reductions, whether within a month or otherwise, statements concerning the Company’s expected product development efforts and future clinical studies and regulatory submissions and whether the Company might obtain regulatory approval to market and sell the nsPFA Percutaneous Electrode System as a treatment for benign thyroid nodules, statements concerning whether any clinical study will show that the Company’s novel nsPFA mechanism of action will deliver fast and precise ablations, statements concerning early clinical successes and whether they are predictive of the safety and effectiveness of any medical device such as the nsPFA Percutaneous Electrode System, and Pulse Biosciences’ expectations, whether stated or implied, regarding whether the Company’s CellFX nsPFA technology will become a disruptive, superior and durable treatment option for treating benign thyroid nodules or any other medical condition or otherwise advance current medical standards of care, and other future events. These statements are not historical facts but rather are based on Pulse Biosciences’ current expectations, estimates, and projections regarding Pulse Biosciences’ business, operations and other similar or related factors. Words such as “may,” “will,” “could,” “would,” “should,” “anticipate,” “predict,” “potential,” “continue,” “expects,” “intends,” “plans,” “projects,” “believes,” “estimates,” and other similar or related expressions are used to identify these forward-looking statements, although not all forward-looking statements contain these words. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties, and assumptions that are difficult or impossible to predict and, in some cases, beyond Pulse Biosciences’ control. Actual results may differ materially from those in the forward-looking statements as a result of a number of factors, including those described in Pulse Biosciences’ filings with the
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