What's Happening?
Pulse Biosciences, Inc. has announced the successful completion of the first procedures in its PRECISE-BTN study, which focuses on treating benign thyroid nodules using its proprietary Nanosecond Pulsed Field Ablation (nsPFA) technology. The study, approved by an Institutional Review Board (IRB), is being conducted across multiple centers and aims to demonstrate the safety and efficacy of the nsPFA Percutaneous Electrode System. The initial procedures were performed at Sarasota Memorial Hospital in Florida, under the guidance of Dr. Ralph P. Tufano. The study will involve up to 50 patients and will assess outcomes such as safety, nodule volume reduction, and quality of life improvements over a 12-month follow-up period.
Why It's Important?
This development is significant as it represents a potential advancement in the treatment of benign thyroid nodules, which are common and can cause significant symptoms. The nsPFA technology offers a non-invasive alternative to traditional surgical methods, potentially preserving thyroid function and reducing the need for complete thyroid removal. Successful outcomes from this study could lead to broader adoption of this technology, benefiting patients by minimizing surgical risks and improving recovery times. Additionally, it underscores Pulse Biosciences' commitment to advancing medical technology and improving patient care.
What's Next?
The study will continue to enroll patients and conduct follow-up evaluations at 1, 3, 6, and 12 months post-procedure. Pulse Biosciences plans to provide updates as more data becomes available. The company is also progressing with the commercial launch of its technology, which could further expand its application in other medical fields.
