Pulse Biosciences, Inc. (NASDAQ: PLSE) has recently achieved a significant milestone by enrolling the first patients in a multi-center first-in-human feasibility study for the treatment of papillary thyroid microcarcinoma (PTM) using its proprietary npulse™ Vybrance™ percutaneous electrode system. The study aims to evaluate the safety and effectiveness of the system in treating papillary thyroid cancer tumors less than 1.5 cm in size.
The company completed the initial procedures at Sarasota Memorial Health Care System in Sarasota, Florida, and the University of Texas MD Anderson Cancer Center in Houston, Texas. The first patient was enrolled and treated by Dr. Ralph P. Tufano, the director of the multidisciplinary thyroid and parathyroid center at Sarasota Memorial, while two subsequent cases were completed by principal investigator Dr. Victoria Banuchi, associate professor of head & neck surgery at UT MD Anderson.
The npulse™ Vybrance™ percutaneous electrode system, which received U.S. Food and Drug Administration (FDA) 510(k) clearance for the ablation of soft tissue, is now being evaluated under an investigational device exemption (IDE) specifically for thyroid cancer applications.
Dr. Tufano expressed optimism about the potential of npulse technology to offer a safe and effective alternative to surgery or serial surveillance for select patients with low-risk thyroid cancer. This nonthermal approach could spare critical surrounding structures, providing a minimally invasive treatment option.
Paul LaViolette, Co-Chairman and CEO of Pulse Biosciences, highlighted the nonthermal mechanism of action of npulse technology, positioning it as a potential treatment option for both benign and malignant thyroid tumors.
The company's npulse Vybrance percutaneous electrode system, designed for non-cardiac applications, consists of a percutaneous needle electrode for use with the company’s proprietary npulse console. It delivers nanosecond pulses of electrical energy to non-thermally clear cells while sparing adjacent noncellular tissue.
This development underscores Pulse Biosciences' commitment to rigorously generating data and demonstrating the potential to improve patient outcomes, providing clinicians with more precise, tissue-sparing tools for minimally invasive treatment applications.
Pulse Biosciences, Inc. is actively pursuing the development of its npulse technology for use in the treatment of atrial fibrillation and in select few other markets where it could have a positive impact on healthcare for both patients and providers, such as surgical soft tissue ablation. As a result of these announcements, the company's shares have moved 1.06% on the market, and are now trading at a price of $14.25. Check out the company's full 8-K submission here.
