Pulse Biosciences launches clinical study for thyroid nodule treatment

Pulse Biosciences launches thyroid nodule treatment: ©Sebastian Kaulitzki - stock.adobe.com

Pulse Biosciences Inc. announced the first successful procedures in a multicenter study using its nanosecond pulsed field ablation (nsPFA) technology to treat benign thyroid nodules.

The company said the procedures, part of the PRECISE-BTN clinical trial, were performed with its nsPFA Percutaneous Electrode System. The study is being led by Ralph P. Tufano, director of Head and Neck Endocrine Surgery at Sarasota Memorial Hospital in Florida.

“Successful procedures for the first enrolled patients in our PRECISE-BTN clinical study for the treatment of benign thyroid nodules 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,” Tufano said in a statement.

The PRECISE-BTN trial is a prospective, single-arm study that will include up to 50 patients across four sites. Participants will undergo soft tissue ablation procedures for thyroid nodules and be evaluated at One, three, six and 12 months post-procedure. Study endpoints include safety, targeted nodule volume reduction, symptom relief, and improvements in quality of life.

Paul LaViolette, CEO and co-chairman of Pulse Biosciences, said the study builds on the company’s commercial pilot program. “The progression of our clinical studies highlights our commitment to advancing patient treatment and providing valuable insights and outcomes in our field,” he said.

Advances in thyroid nodule treatment

Treatment of benign thyroid nodules has shifted in recent years as researchers and clinicians seek less invasive options that preserve thyroid function. Traditionally, patients with symptomatic nodules faced surgery, which often required complete or partial removal of the thyroid gland. While effective, surgery carries risks such as damage to the vocal cords, hypoparathyroidism, and the need for lifelong thyroid hormone replacement therapy.

Energy-based ablation technologies have emerged as alternatives to surgery. Radiofrequency ablation (RFA) and laser ablation have shown success in shrinking nodules while reducing symptoms like neck swelling, difficulty swallowing, and cosmetic concerns. Studies have demonstrated that these methods can preserve thyroid tissue and reduce the need for surgical intervention, making them attractive options for patients with benign conditions.

More recently, pulsed field ablation technologies, including nanosecond pulsed field ablation, are being explored for their ability to selectively target and destroy nodule tissue without damaging surrounding structures. This approach could further reduce complications and recovery times compared with thermal ablation methods.

Clinical research is also focusing on patient quality of life, recognizing that even benign thyroid nodules can significantly affect comfort, appearance, and mental well-being. Ongoing trials are evaluating long-term outcomes such as sustained nodule reduction, recurrence rates, and patient satisfaction.

These advances highlight a growing shift toward organ-preserving, minimally invasive therapies that aim to treat symptoms effectively while minimizing risks and maintaining normal thyroid function.