Medical Device News Magazine

Update on FDA 510(k) Submission for the CellFX System in Dermatology: Reported by Pulse Biosciences

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Summation

  • On February 13, 2020, the Company received a Not Substantially Equivalent (NSE) letter from FDA indicating that, based on the data provided, the Company has not demonstrated that the CellFX System is substantially equivalent to the predicate device.

Pulse Biosciences, Inc. is a novel bioelectric medicine company, today announced an update on its U.S. Food and Drug Administration (FDA) submission for the CellFX System. Previously, the Company submitted a 510(k) to FDA seeking clearance to commercialize its CellFX System. On February 13, 2020, the Company received a Not Substantially Equivalent (NSE) letter from FDA indicating that, based on the data provided, the Company has not demonstrated that the CellFX System is substantially equivalent to the predicate device. The Company will continue to work with FDA in pursuit of clearance via a new 510(k) submission and is prepared to provide additional clinical data as required.

We remain highly confident in the CellFX System and its safety and efficacy profile in aesthetic dermatology. We look forward to continuing to work with FDA to obtain a clearance for the CellFX system in dermatology.” said Darrin Uecker, President and CEO of Pulse Biosciences. “We will continue to generate additional clinical data in support of that effort with the great group of leading dermatologists we have been collaborating with in previous studies.”

“I am pleased our Board of Directors has approved Pulse Biosciences to take the steps necessary to pursue a right offering to raise an additional $30 million in net proceeds,” said Robert Duggan, Chairman of the Board of Directors. “In my position as our largest shareholder, I intend to subscribe to my ownership percent interest and all additional shares that may become available. I am a believer in our team, our technology, and what I perceive to be a substantive human healthcare opportunity.”

Investors may call Tuesday, February 18, 2020 at 2:00pm PT at (844) 494-0190 from the US or (508) 637-5580 from outside the US, using conference ID: 2183594.

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