Research & Development
Pulse Biosciences Withdraws 510(k) Application for the PulseTx System
12 September 2017 - - Burlingame, California-based nano-pulse stimulation (NPS) technology specialist Pulse Biosciences, Inc. (NASDAQ: PLSE) has withdrawn its initial application to the United States Food and Drug Administration for 510(k) clearance of its PulseTxTMSystem, the company said.
The voluntary withdrawal on 8 September 2017, was the result of the FDA's appropriate request for additional data that could not be provided within the Agency's 90-day review period that would have otherwise ended on 10 September 2017.
Pulse Biosciences is committed to generating the requested data and analysis, and the company plans to submit the supplemental information in a subsequent 510(k) application in the coming months.
Pulse Biosciences is a medical technology company developing a therapeutic tissue treatment platform based on proprietary cell signaling technology, nano-pulse stimulation (NPS), 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 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.