Pulse Biosciences Reports 86% Primary Endpoint Hit in PRECISE-BTN Six-Month Interim Data
PLSE has more than doubled off its 52-week low of $12.56.
Summary
Pulse Biosciences released interim six-month PRECISE-BTN data: 86% of 43 evaluated patients hit the 50% nodule reduction endpoint, median reduction 72%, no serious adverse events. Full six- and 12-month results are still pending.
Key Events · Product Development and Regulatory · PLSE
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PRECISE-BTN Interim Data Beats Primary Endpoint
86% of the 43 patients evaluated at six months achieved at least 50% nodule volume reduction, the study's primary endpoint, after a single nonthermal nsPFA treatment.
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Median Volume Reduction 72%
Median nodule volume reduction was 72% at six months, with most of the reduction visible by the one-month visit and continuing to improve.
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Quality-of-Life and Symptom Gains
ThyPRO-39 Overall Quality of Life Impact improved 78% from baseline, and 82% of patients with baseline neck pressure or fullness reported full resolution at six months.
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Clean Safety Profile So Far
No serious adverse events were reported in the interim dataset; the procedure is ultrasound-guided and designed to spare nerves and vessels.
Analysis · PLSE · Industrial Applications And Services
The first six-month efficacy readout from PRECISE-BTN is strong: 86% of the 43 evaluated patients cleared the 50% nodule-volume-reduction bar, median reduction was 72%, and there were no serious adverse events. That matters because benign thyroid nodules are a large, currently surgery-or-radioiodine market, and a same-day, nonthermal, thyroid-function-sparing procedure is the commercial pitch behind the Vybrance electrode. The caveat is that this is an interim slice — only 43 of the 100 enrolled patients have reached six months — so the full primary-endpoint dataset and the 12-month follow-up still have to confirm the result. No financial terms, guidance, or capital action are in this filing.
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At the time of this filing, PLSE was trading at $50.80 on NASDAQ in the Industrial Applications And Services sector, with a market capitalization of approximately $3.9B. The 52-week trading range was $12.56 to $58.90. This filing was assessed with positive market sentiment and an importance score of 7 out of 10.