Pulse Biosciences Inc. has conducted the first successful procedures in a multicenter IRB-approved study using its nsPFA Percutaneous Electrode System to treat benign thyroid nodules (BTNs).

“Successful procedures for the first enrolled patients in our PRECISE-BTN clinical study for the treatment of benign thyroid nodules (BTNs) marks a significant milestone not only for Pulse Biosciences but also for the broader medical community and patients who stand to benefit from this organ-sparing technology,” said Dr. Ralph P. Tufano, director of Head and Neck Endocrine Surgery at Sarasota Memorial Hospital (SMH) in Sarasota, Fla., and principal investigator for the PRECISE-BTN study conducted through SMH’s Kolschowsky Research and Education Institute and Brian D. Jellison Cancer Institute. “The objective of this multicenter clinical study is to continue to build clinical evidence in support of this patient-friendly procedure by showing we can safely reduce the debilitating symptoms caused by BTNs, while preserving thyroid function and avoiding complete thyroid removal. Our first two procedures were successful, and we are showing early positive results. We look forward to providing further updates as patients progress.”

The PRECISE-BTN study is a prospective, single arm, multicenter, clinical trial using the Pulse Biosciences nsPFA Percutaneous Electrode System to treat BTNs. Benign thyroid nodule soft tissue ablation procedures will be performed on up to 50 patients with the nsPFA Percutaneous Electrode System across four sites. Per study protocols, patients will be observed and evaluated in follow-up visits to assess the procedure at one, three, six, and 12 months post-procedure. Study endpoints evaluated during the follow-up timepoints include safety, targeted nodule volume reduction, symptom reduction, and improvements in quality of life and cosmesis.

“In addition to the work done to enroll and treat our first patients in the PRECISE-BTN multicenter clinical study, we continue to successfully treat patients through the pilot phase of our commercial launch,” Pulse Biosciences Co-Chairman/CEO Paul LaViolette stated. “The progression of our clinical studies highlights our commitment to advancing patient treatment and providing valuable insights and outcomes in our field.”

Pulse Biosciences is a bioelectric medicine company committed to health innovation that has the intention as well as the potential to improve patients’ quality of life. The company’s proprietary CellFX nsPFA technology delivers nanosecond electrical energy pulses to non-thermally clear cells while sparing adjacent noncellular tissue. The company is actively pursuing the development of its CellFX nsPFA technology for use in treating atrial fibrillation and in a select few other markets where it could have a profound positive impact on healthcare for both patients and providers, such as surgical soft tissue ablation.