HAYWARD, Calif.--(BUSINESS WIRE)--Pulse Biosciences, Inc. (NASDAQ:PLSE), a novel medical therapy company bringing to market its proprietary CellFX™ System today announced the Premarket Notification 510(k) submission to the U.S. Food and Drug Administration (FDA) for its CellFX System. The Company’s FDA filing requests clearance of the CellFX System for commercial use in common dermatologic procedures to remove general benign lesions including sebaceous hyperplasia (SH), a common but difficult to treat facial lesion and seborrheic keratosis (SK), the most common benign raised pigmented lesion.
Pursuant to Section 510(k), once the application has been accepted, the FDA will conduct its substantive review and may request additional information from the Company based on that review. FDA guidance suggests the goal for FDA 510(k) review is 90 calendar days, not including time required by the Company to respond to additional information requests. The time required to respond to such requests will depend on the nature of the request.
“We are pleased to announce this important milestone, a key step in bringing the CellFX System to the aesthetic dermatology market,” said Darrin Uecker, President and Chief Executive Officer. “Our FDA submission announced today is supported by the safety and efficacy data from our clinical studies as well as pre-clinical and bench data in support of the use of the CellFX System in dermatology. We look forward to working with FDA throughout the review process and to achieving our goal of an FDA clearance that will lead to commercialization.”
About Pulse Biosciences
Pulse Biosciences is a novel medical therapy company bringing to market its proprietary CellFX™ System. The Company’s novel CellFX System provides a precise, non-thermal delivery of nanosecond duration energy pulses that impact cells in treated tissue while sparing acellular tissue. This unique mechanism of action disrupts 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. The novel characteristics of the Company’s CellFX System has the potential to significantly benefit patients across multiple medical applications, including dermatology, the Company’s first planned commercial application. In pre-clinical studies, NPS has demonstrated an ability to induce immunogenic cell death in several cancer cell lines. The Company believes its NPS platform technology may play a role in immuno-oncology as a focal tumor treatment that can initiate an adaptive immune response. More information can be found at www.pulsebiosciences.com.
All statements in this press release that are not historical are forward-looking statements, including, among other things, statements relating to or implying Pulse Biosciences’ expectations regarding commercialization of the CellFX System, regulatory clearance and the timing of FDA filings or approvals for products and indications, matters related to its pipeline of product candidates, future financial performance and business strategies 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. 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 release to reflect events or circumstances in the future, even if new information becomes available.
CAUTION: Pulse Biosciences’ CellFX System and Nano-Pulse Stimulation (NPS) are for investigational use only.