Pulse Biosciences reports interim thyroid nodule study results

Hayward, California - Pulse Biosciences Inc. (NASDAQ:PLSE) unveiled interim six-month findings from its PRECISE-BTN study, which assessed the nPulse Vybrance Percutaneous Electrode System for benign thyroid nodule treatment. Presenting the data at the American Thyroid Association's annual meeting in Philadelphia, the analysis encompassed 43 patients treated at three U.S. centers up to the six-month mark.

According to the company's press release, 86% of patients experienced at least a 50% reduction in nodule volume at six months, which served as the primary endpoint. The median volume reduction was an impressive 72% at the same time point. Additionally, the ThyPRO-39 Overall Quality of Life Impact score showed a significant improvement of 78% from baseline at six months.

Among patients reporting neck pressure or fullness at baseline, 82% saw the symptom completely resolve by the six-month assessment. No serious adverse events were reported in the study. Ralph Tufano, Director of the Multidisciplinary Thyroid and Parathyroid Center at Sarasota Memorial Hospital and principal investigator of the study, commented on the promising results, stating that volume reduction was evident within the first month and persisted throughout the six-month period, leading to meaningful improvements in symptoms and quality of life for most patients.

The PRECISE-BTN study is a prospective, single-arm, multicenter investigation that enrolled 100 patients at three U.S. centers, with follow-up appointments scheduled at one, three, six, and 12 months post-procedure. Utilizing the nPulse Vybrance system, which delivers nanosecond pulses of electrical energy in an ultrasound-guided procedure and is nonthermal, allowing patients to return home on the same day, Pulse Biosciences anticipates reporting data for all patients at six and 12 months once follow-up is completed.