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Pulse Biosciences Reports Fourth Quarter and Full Year 2019 Financial Results
HAYWARD, Calif.--(BUSINESS WIRE)-- Pulse Biosciences, Inc. (Nasdaq: PLSE), a novel bioelectric medicine company, today announced financial results for the
About this update from Pulse Biosciences, Inc
[{"type":"text","content":" HAYWARD, Calif.--(BUSINESS WIRE)--\nPulse Biosciences, Inc. (Nasdaq: PLSE), a novel bioelectric medicine company, today announced financial results for the fourth quarter and full year ended December 31, 2019.\n\n\nRecent Highlights\n\n\n\nNano-Pulse Stimulation™ (NPS™) technology was highlighted in three clinical study presentations demonstrating its high clearance rates of benign skin lesions at the Annual Meeting of the American Society for Dermatologic Surgery.\n\n\nPresented data from a study evaluating the clinical and histologic response of NPS technology in treating challenging cases of nodular Basal Cell Carcinoma at the International Master Course on Aging Skin World Congress.\n\n\nCompleted enrollment in the Company’s CellFX Warts Pivotal Study.\n\n\nObtained ISO-13485:2016 Quality System Management Certification to begin preparations for international commercialization of the CellFX System.\n\n\nAppointed industry veteran Sandra Gardiner as Executive Vice President and Chief Financial Officer.\n\n\nAnnounced Board approval to pursue a rights offering seeking to raise $30 million in net proceeds.\n\n\nFollowing receipt of a Not Substantially Equivalent Letter from the U.S. Food and Drug Administration (FDA) on its previous 510(k) submission, the Company remains engaged with FDA to determine the regulatory path forward for the CellFX System. The Company recently requested a formal Q-submission meeting with FDA to discuss requirements for a new 510(k) submission and based on recent communication, expects the meeting to take place in May.\n\n\n\n“I am proud of our continued work to develop NPS technology across multiple clinical applications. We’ve developed a novel and proprietary platform, the CellFX System, that implements a novel utilization-based business model to align incentives between physicians, patients and Pulse Biosciences. Our top priority remains FDA clearance for use of the CellFX System in aesthetic dermatology,” said Darrin Uecker, President and CEO of Pulse Biosciences. “After recent developments and collaboration with FDA, we are refocused on generating and providing additional data that will support a new 510(k) submission for what we believe will be a general dermatologic indication. Our confidence in the technology continues to grow and we remain excited about the potential of our system.”\n\n\nFi...