Pulse Biosciences, Inc. filed a Form 8-K on November 6, 2026, disclosing interim six-month results from its PRECISE-BTN clinical study evaluating the nPulse Vybrance Percutaneous Electrode System for symptomatic benign thyroid nodules.

Key Highlights

  • Primary endpoint met in 86% of patients: 86% of the 43 evaluated patients achieved at least 50% nodule volume reduction at six months, the study's primary endpoint.
  • Median volume reduction of 72%: The median nodule volume reduction at six months was 72%, with most reduction evident by the one-month visit and continuing to improve over time.
  • Quality of life improvement: The ThyPRO-39 Overall Quality of Life Impact score improved by 78% from baseline at six months.
  • Symptom resolution: 82% of evaluated patients who reported neck pressure or fullness at baseline reported full resolution of that symptom at six months.
  • No serious adverse events: The filing reported no serious adverse events in the interim dataset.
  • Three U.S. clinical sites: Patients were treated at Sarasota Memorial Health Care System, NYU Langone Health, and Weill Cornell Medicine.

PRECISE-BTN Interim Findings: Six-Month Results in 43 Patients

According to the filing, Pulse Biosciences (NASDAQ:PLSE) announced interim six-month results from its PRECISE-BTN clinical study on November 6, 2026. The study is evaluating the company's nPulse Vybrance Percutaneous Electrode System for the treatment of symptomatic benign thyroid nodules. The disclosed interim dataset is drawn from six-month evaluations of 43 patients enrolled in the study.

The company disclosed that the study's primary endpoint is nodule volume reduction of at least 50% at six months, with additional endpoints covering safety, symptomatic relief, and improvements in quality of life. The filing states that 86% of evaluated patients achieved the primary endpoint. Median volume reduction was reported as 72% at six months, with the filing noting that "the majority of reduction evident by the one-month visit and continuing to improve over time."

On quality of life, the filing reported a 78% improvement from baseline in the ThyPRO-39 Overall Quality of Life Impact score at six months. Regarding symptom relief, 82% of patients who had reported neck pressure or fullness at baseline indicated full resolution of that symptom at six months. The filing also stated there were no reported serious adverse events. A press release related to these results was attached as Exhibit 99.1 and incorporated by reference. The 8-K was signed by Jon Skinner, Chief Financial Officer, as Principal Financial Officer.

What Was Disclosed

Pulse Biosciences filed an 8-K disclosing interim six-month clinical results from the PRECISE-BTN study across 43 patients, covering nodule volume reduction, quality of life scores, symptom resolution, and safety outcomes for its nPulse Vybrance system.