Pulse Biosciences Completes Enrollment in PRECISE-BTN Clinical Study

What Happened Pulse Biosciences, Inc. (PLSE) filed an 8-K on September 15, 2026 announcing that it has completed patient enrollment in the PRECISE-BTN clinical study of its nPulse™ Vybrance™ Percutaneous Electrode System for symptomatic benign thyroid nodules. The study was expanded from an original 50‑patient design to 100 patients, and all patients were enrolled across three U.S. sites within approximately 12 months. The first patient enrolled has completed the final 12‑month follow‑up visit.

Key Details

• Enrollment expanded from 50 to 100 patients and was completed across three sites: Sarasota Memorial Health Care System, NYU Langone Health, and Weill Cornell Medicine.
• The first patient completed their 12‑month follow‑up as of the filing date (Sept 15, 2026).
• Study follow‑up visits are at 1, 3, 6, and 12 months; endpoints include safety, targeted nodule volume reduction, symptomatic relief, hormone normalization, and quality‑of‑life improvements.
• The company attached a press release about the enrollment completion as Exhibit 99.1 to the 8‑K.

Why It Matters Completing enrollment is a key clinical milestone that reduces enrollment risk and allows the company to proceed toward full data evaluation against the study endpoints. The 12‑month follow‑up for the first patient indicates the study is producing longer‑term data needed to assess safety and efficacy, which are important for regulatory review and commercial planning. For investors, these facts signal progress in the clinical program and set the stage for future data disclosures.