Pulse Biosciences Receives FDA Clearance

By Bobby Samwell • Monday, March 11 10:26 • Permanent Link

On March 8, 2024, Pulse Biosciences, Inc. (NASDAQ: PLSE) announced a significant achievement with the receipt of U.S. Food and Drug Administration (FDA) 510(k) clearance for its novel CellFX NSPFA percutaneous electrode system. This clearance marks a major milestone for the company in the field of surgery, opening new clinical applications and opportunities for the proprietary, patented CellFX NSPFA technology.

The CellFX NSPFA percutaneous electrode system consists of a percutaneous needle electrode designed to deliver the advantages of NSPFA energy, allowing for precise, nonthermal removal of cellular tissue without causing damage to noncellular structures or inducing thermal necrosis. This system is intended for non-cardiac applications, offering a minimally invasive nonthermal treatment option for patients.

Kevin Danahy, President and CEO of Pulse Biosciences, expressed pride in the engineering, clinical, and regulatory teams for their commitment to bringing the safety and effectiveness benefits of NSPFA to physicians, caretakers, and patients. He also highlighted the company's manufacturing and operational readiness as they prepare to initiate training and commercialization programs in the coming weeks.

Dr. Ralph P. Tufano, the company’s senior advisor and scientific advisory board chair, emphasized the potential of the CellFX NSPFA percutaneous electrode system as a promising minimally invasive nonthermal treatment option for patients. He noted the system's intuitive usability, short procedure times, and customizable energy delivery for treating a variety of patients requiring soft tissue ablation.

Pulse Biosciences is actively pursuing the development of its CellFX NSPFA technology for use in the treatment of atrial fibrillation and in select markets where it could have a positive impact on healthcare for both patients and providers. The company's proprietary technology delivers nanosecond pulses of electrical energy to non-thermally clear cells while sparing adjacent noncellular tissue, showcasing its potential for improving patient outcomes.

With the FDA clearance for the CellFX NSPFA percutaneous electrode system, Pulse Biosciences is poised to make significant strides in the field of bioelectric medicine, furthering its commitment to health innovation and the potential to improve the quality of life for patients.

Today the company's shares have moved 16.2% to a price of $11.21. For the full picture, make sure to review Pulse Biosciences's 8-K report.

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