Biotech Values

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PLSE

HAYWARD, Calif.--(BUSINESS WIRE)--Pulse Biosciences, Inc. (Nasdaq:PLSE), a medical technology company developing a proprietary therapeutic tissue treatment based on its Nano-Pulse Stimulation (NPS) platform, announced today that it has withdrawn its initial application to the United States Food and Drug Administration (FDA) for 510(k) clearance of its PulseTxTM System.

The voluntary withdrawal on September 8, 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 September 10, 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.