First-in-Human Clinical Feasibility Study Demonstrates Effectiveness of Ablation of Benign Thyroid Nodules Using Nanosecond Pulsed Field Ablation
Pulse Biosciences, a company leveraging its novel and proprietary Nanosecond Pulsed Field Ablation technology, announced a new publication in the Journal Thyroid. The First-in-Human Clinical feasibility study demonstrates the effectiveness of ablation of benign thyroid nodules using nsPFA energy.
The study was designed to assess the ability of nsPFA energy to provide a safe and effective option for the treatment of symptomatic benign thyroid nodules with minimal side effects. The study was conducted by Professor Stefano Spiezia as a single-arm First-In-Human feasibility study at the Ospedale del Mare center in Naples, Italy. The CellFX nsPFA Percutaneous Electrode System was used under ultrasound guidance to ablate benign thyroid nodules, as either isolated ablations to assess tissue response (Cohorts 1 & 2) or for full treatment of thyroid nodules with therapeutic intent (Cohort 3). Results showed no intranodular fibrosis or scarring on follow-up ultrasounds and fully treated nodules (Cohort 3) had up to 93% reduction in size at 1 year on ultrasound assessment (average 86% reduction), with symptom relief and >48% reduction as early as 2 weeks.
Health Technology Insights: Sonoma Biotherapeutics Appoints Lisa Taylor Ash, as Chief Legal Officer
“We are very proud to have this data published in a leading scientific journal in the field, the renowned Journal Thyroid. The results of this study are extremely compelling and demonstrate nsPFA’s ability to offer advantages in treating benign thyroid nodules compared to other methods such as thyroidectomy or thermal ablation. This technology provides a favorable safety profile, rapid symptom reduction, and lack of internodular fibrosis and scarring,” said Dr. Stefano Spiezia, Chief of Endocrine Surgery at Ospedale del Mare. “These benefits are very appealing to surgeons who always prioritize generating consistent positive outcomes for their patients with increased safety and effectiveness.”
Health Technology Insights: Devonian Issues Corporate Update and Private Placement Information
Dr. Ralph Tufano, Pulse Biosciences’ Scientific Advisory Board Chair, Head and Neck Surgery, commented, “Unlike RFA, the nonthermal mechanism of nsPFA preserves surrounding nerves and blood vessels, allowing for safe and effective treatment of the entire nodule, even when located in sensitive areas like near the recurrent laryngeal nerve, esophagus, trachea, and critical arteries. Another key advantage of nsPFA over RFA is its significantly faster rate of thyroid nodule volume reduction: nsPFA achieved a 71% reduction within just one month, whereas RFA-treated nodules in four large clinical trials typically required six months to reach comparable shrinkage. The rapid reduction in nodule size combined with the absence of adverse effects supports the feasibility of this new approach and its potential to improve patient outcomes.”
A Late-Breaking Abstract of this work was presented at the 2024 American Thyroid Association meeting.
Health Technology Insights: Biofrontera Completes Phase 2b Study of Ameluz for Acne Vulgaris
To participate in our interviews, please write to our HealthTech Media Room at sudipto@intentamplify.com
Source- businesswire
