Pulse Biosciences, Inc. (NASDAQ: PLSE) reported Q3 EPS of ($0.51), $0.07 worse than the analyst estimate of ($0.44).

Recent Highlights

• Submitted a 510(k) Premarket Notification application to the U.S. Food and Drug Administration (FDA) for the CellFX® System seeking to obtain initial clearance for a general dermatologic indication. Potential clearance remains on track to be received as early as the first quarter of 2021.
• Received FDA Investigational Device Exemption (IDE) approval and completed enrollment ahead of schedule in a pivotal comparison study to evaluate the treatment of sebaceous hyperplasia (SH) lesions using the CellFX System, accelerating the planned 510(k) submission into the first quarter of 2021 versus the previous estimate of the second quarter of 2021.
• Submitted a Medical Device License application to Health Canada for the CellFX System after receiving the Medical Device Single Audit Program certification, now on track for a potential Health Canada license as early as the first quarter of 2021.
• Advanced the interactive review process with the notified body and on track for potential controlled launch in the European Union as early as the first quarter of 2021.
• Clinical results from four studies of the CellFX System were presented at the American Society for Dermatologic Surgery virtual annual meeting on October 9-11, 2020.

“We made excellent progress over the last several months on our clinical and regulatory objectives. We remain on track to potentially receive marketing clearances for our CellFX System in our three top geographies, the United States, Canada, and the European Union by the end of the first quarter of 2021. Additionally, completing enrollment in our sebaceous hyperplasia pivotal study in just over five weeks, two months ahead of schedule, is a testament to the interest physicians and patients have regarding the CellFX procedure for this application,” said Darrin Uecker, President and CEO of Pulse Biosciences. “Importantly, I would like to thank our team for their hard work and recognize their accomplishments during this last quarter.”

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