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Pulse Biosciences Announces FDA IDE Approval and Initiation of Sebaceous Hyperplasia Study
Completes First Procedures in CellFX System Specific Indication Study HAYWARD, Calif.--(BUSINESS WIRE)-- Pulse Biosciences, Inc. (Nasdaq: PLSE), a novel
About this update from Pulse Biosciences, Inc
[{"type":"text","content":"\nCompletes First Procedures in CellFX System Specific Indication Study\n\n HAYWARD, Calif.--(BUSINESS WIRE)--\nPulse Biosciences, Inc. (Nasdaq: PLSE), a novel bioelectric medicine company progressing Nano-Pulse Stimulation™ (NPS™) technology, today announced FDA Investigational Device Exemption (IDE) approval and initiation of a pivotal study to evaluate the treatment of sebaceous hyperplasia (SH) lesions using the CellFX® System. The data generated from this study is intended to support a 510(k) submission to expand the indication for use of the CellFX System specifically to treat SH lesions.\n\nFollowing IDE approval, several patients have been enrolled, with the first patient procedure completed on September 28, 2020. The multicenter prospective comparative study is intended to evaluate the safety and efficacy of procedures to clear facial SH lesions performed with the CellFX System versus those performed by electrodessication in a comparator group. Enrollment of 60 patients across five study sites is expected to be completed in approximately three months. All subjects will have up to two treatments and will be evaluated through the primary safety and efficacy endpoints at 60-days following their last treatment. The ClinicalTrials.gov Identifier for the study is NCT04539886.\n\n“We are pleased to have received FDA IDE approval and to have begun this important SH comparative study slightly ahead of the fourth quarter start we had previously communicated. Understanding the COVID-19 pandemic has increased the demand on FDA resources, we appreciate their attention throughout the IDE process. Barring delays in enrollment, we expect to conclude the study in the first quarter of 2021 and plan to quickly follow with a 510(k) submission for the corresponding specific indication. We have long viewed SH as a top addressable market priority for the CellFX System based on patient demand in clinics today and the CellFX System’s early demonstration of procedure effectiveness,” said Darrin Uecker, President and CEO of Pulse Biosciences. “As we have communicated previously, in parallel we are completing our GLP preclinical study in support of the initial CellFX System 510(k) submission for a general dermatologic indication. We remain on track to submit this 510(k) in the next several weeks.”\n\nAbout Sebaceous Hyperplasia\n\nSebaceous hyperp...