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Pulse Biosciences Updates on CellFX System Regulatory and Clinical Study Progress
HAYWARD, Calif.--(BUSINESS WIRE)-- Pulse Biosciences, Inc. (Nasdaq: PLSE) (“Pulse Biosciences” or the “Company”), a novel bioelectric medicine company
About this update from Pulse Biosciences, Inc
[{"type":"text","content":" HAYWARD, Calif.--(BUSINESS WIRE)--\nPulse Biosciences, Inc. (Nasdaq: PLSE) (“Pulse Biosciences” or the “Company”), a novel bioelectric medicine company progressing Nano-Pulse Stimulation™ (NPS™) technology, today announced CellFX® System regulatory progress updates.\n\nRecent CellFX System Highlights\n\n\nReceived notification from the Food and Drug Administration (FDA) that the Company’s 510(k) submission for a general dermatology indication for the CellFX System has advanced from Substantive Review to Interactive Review.\n\n\nCompleted all treatments in the Company’s previously announced pivotal comparison study to evaluate the treatment of sebaceous hyperplasia (SH) using the CellFX System, with the planned specific indication 510(k) submission as early as the end of the first quarter of 2021.\n\n\nObtained FDA Investigational Device Exemption (IDE) approval of a pivotal comparison study to evaluate the treatment of cutaneous non-genital warts using the CellFX System, with enrollment expected to begin by the end of the first quarter of 2021.\n\n\nContinued review by the Notified Body of the CellFX System for CE mark approval and Health Canada for Medical Device License remains on track.\n\n\n“We are very pleased with the progress our team made throughout a challenging 2020 in advancing the CellFX System and in interactions with regulatory authorities in the US, European Union and Canada,” said Darrin Uecker, President and Chief Executive Officer of Pulse Biosciences. “We continue to work with the regulatory authorities in each of these geographies and appreciate the collaborative and timely interactions we have had during these reviews.”\n\nAbout Pulse Biosciences®\n\nPulse Biosciences is a novel bioelectric medicine company committed to health innovation that has the potential to improve the quality of life for patients. If cleared, the CellFX® System is the first commercial product to harness the distinctive advantages of the Company’s proprietary Nano-Pulse Stimulation™ (NPS™) technology, such as the ability to non-thermally clear cells while sparing non-cellular tissue, to treat a variety of applications for which an optimal solution remains unfulfilled. Nano-Pulse Stimulation technology delivers nano-second pulses of electrical energy. Subject to regulatory approval, the initial commercial use of the CellFX System is to...