Pulse Biosciences Submits 510(k) Application To FDA For PulseTx System

BURLINGAME, Calif.--(BUSINESS WIRE)--Pulse Biosciences, Inc. (Nasdaq:PLSE), a medical technology company developing a proprietary therapeutic tissue treatment platform based on Nano-Pulse Stimulation (NPS), today announced the submission of a 510(k) to the US Food and Drug Administration for its PulseTx™ System.

“The PulseTx 510(k) submission is an important step in our mission to improve healthcare by delivering this unique technology to physicians and their patients”

NPS is a non-thermal drug-free tissue treatment technology that can stimulate unique behaviors in cells by applying ultra-short nanosecond duration electrical pulses that affect the cell membrane and intracellular structures. NPS can be used for tissue removal by inducing cell death in tissue cells with minimal inflammatory response, which improves healing and supports the replacement of treated tissue cells with healthy tissue cells. In preclinical cancer studies, NPS has been shown to induce immunogenic cell death, a cell death process that destroys the treated cells and exposes the tumor cell antigens to the immune system, resulting in the generation of cytotoxic T-cells and the mounting of an adaptive immune response targeted against the tumor cells.

PulseTx is the Company’s proprietary NPS delivery platform designed for broad application across many tissue treatment indications. The PulseTx system features a tunable nanosecond pulse generator capable of generating pulses of varying pulse duration, amplitude, frequency and number. It is designed to be used with a suite of interchangeable tissue applicators that are customized to the tissue being treated.

“The PulseTx 510(k) submission is an important step in our mission to improve healthcare by delivering this unique technology to physicians and their patients,” said Darrin Uecker, CEO and President of Pulse Biosciences. “This is our first 510(k) submission, and the first step in our strategy to pursue a general indication for soft tissue ablation followed by submissions for specific indications in the future. We look forward to working with FDA on this important first step.”

Pulse Biosciences has initiated clinical trials to investigate the response of human skin to different treatment levels of NPS and is planning additional trials in skin lesions as well as cancerous lesions.

About Pulse Biosciences

Pulse Biosciences is a medical technology company developing a therapeutic tissue treatment platform based on Nano-Pulse Stimulation, a proprietary cell signaling technology. Nano-Pulse Stimulation is a non-thermal, precise, focal drug-free tissue treatment technology that directly affects the cell membrane and intracellular structures to stimulate unique behaviors in cells. NPS can initiate a cell death process that allows for the treatment of tissue cells with minimal inflammatory response which improves healing outcomes and supports the replacement of treated tissue cells with healthy tissue cells. In cancerous lesions, NPS has been shown in preclinical models to induce immunogenic cell death (ICD) exposing the unique antigens of the treated cells to the immune system, resulting in the generation of cytotoxic T-cells and the mounting of an adaptive immune response targeted against those cells. Pulse Biosciences is investigating a variety of applications for its technology that exploits the technology’s unique biologic effect, including immuno-oncology, dermatology, and veterinary medicine. More information is available at www.pulsebiosciences.com.

Forward-Looking Statements

All statements in this press release that are not historical are forward-looking statements, including, among other things, statements relating to Pulse Biosciences’ expectations regarding regulatory clearance, the mechanism of action of NPS treatments, planned future clinical trials, and other matters related to its pipeline of product candidates and other future events. These statements are not historical facts but rather are based on Pulse Biosciences’ current expectations, estimates, and projections regarding Pulse Biosciences’ business, operations and other similar or related factors. Words such as “may,” “will,” “could,” “would,” “should,” “anticipate,” “predict,” “potential,” “continue,” “expects,” “intends,” “plans,” “projects,” “believes,” “estimates,” and other similar or related expressions are used to identify these forward-looking statements, although not all forward-looking statements contain these words. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties, and assumptions that are difficult or impossible to predict and, in some cases, beyond Pulse Biosciences’ control. Actual results may differ materially from those in the forward-looking statements as a result of a number of factors, including those described in Pulse Biosciences’ filings with the Securities and Exchange Commission. Pulse Biosciences undertakes no obligation to revise or update information in this press release to reflect events or circumstances in the future, even if new information becomes available.