Pulse Biosciences

Pulse Biosciences Seeking 510(K) Approval for CellFX Nanopulse Stimulation System

Pulse Biosciences seeks 501(k) approval

Pulse Biosciences has made a Premarket Notification 510(k) submission to the U.S. Food and Drug Administration (FDA) for its CellFX System, which features the company’s proprietary Nano-Pulse Stimulation (NPS) technology. The filing requests clearance of the CellFX System for commercial use in common dermatologic procedures to remove general benign lesions, including sebaceous hyperplasia (SH) and seborrheic keratosis (SK).

Nano-Pulse Stimulation for Sebaceous Hyperplasia

Nano-Pulse stimulation for SH

Pulse Biosciences has announced positive results from a clinical efficacy study of its proprietary Nano-Pulse Stimulation (NPS) technology for the treatment of sebaceous hyperplasia (SH). Non-thermal NPS delivers nanosecond duration energy pulses to disrupt the functions of internal cell structures while maintaining the outer cell membrane, initiating a cascade of events within the cell that results in regulated cell death.

Triggering Immunity

Nano-pulse electrical stimulation is emerging as a potential treatment for both benign and malignant skin concerns.
Pulse Biosciences

Pulse Biosciences, a company that has developed a Nano-Pulse Stimulation (NPS) technology based on the work of researchers at Old Dominion University in Charleston, South Carolina, and the University of Southern California’s Alfred E. Mann Institute for Biomedical Engineering in Los Angeles, is piquing the interest of dermatologists and immunologists.

Study of Nano-Pulse Stimulation for Sebaceous Hyperplasia Launched

NPS for SH

The first patient in a multicenter study of Nano-pulse Electrical Stimulation (NPS) for Sebaceous Hyperplasia (SH) has been treated, according Pulse Biosciences, creator of the technology. NPS is a non-thermal technology that utilizes ultra-short, nanosecond pulsed electrical fields to directly affect cell membranes and intracellular structures while sparing non-cellular tissues.

Nanopulse Electrical Stimulation Shows Promise for Dermatologic Applications

A new non-thermal technology that targets cellular structures without affecting non-cellular dermal tissue may offer benefits for a range of dermatological concerns. A study on Pulse Biosciences’ Nano-Pulse Stimulation (NPS) technology, entitled “A Dose-Response Study of a New Novel Non-Thermal Method of Selectively Modifying Cellular Structures in Skin with Low Energy Nanosecond Electrical Stimulation,” received the 2018 American Society for Lasers in Medicine and Surgery (ASLMS) Best of Basic Science and Translational Research Award.