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FDA Clears Pulse Biosciences’ CellFX System

The product delivers Nano-Pulse Stimulation technology in dermatologic procedures.

By: Michael Barbella

Managing Editor, Rodman Media

Pulse Biosciences Inc.’s Nano-Pulse Stimulation (NPS) technology is now approved for use in both Europe and the United States. 

The U.S. Food and Drug Administration (FDA) recently cleared the firm’s CellFX System for dermatologic procedures requiring ablation and resurfacing of the skin.

“FDA clearance for the CellFX System is a tremendous achievement for Pulse Biosciences. We received the indication we were pursuing and believe this will be the first of many in this stepwise approach with FDA. This continued progress on our regulatory strategy, following the recent receipt of the CE mark, is another strong validation of the safety and efficacy of our technology. We are proud of our team and thankful to the investigators and FDA for their diligent efforts as part of this accomplishment,” said Darrin Uecker, president and CEO of Pulse Biosciences. “We look forward to proceeding with our Controlled Launch program with KOLs in the United States. This measured approach to launching the CellFX System is our top priority for 2021 and will be key to long-term commercial success of the CellFX platform.”

Pulse Biosciences plans to begin a controlled commercial launch in the United States in the next few weeks with a group of selected Key Opinion Leaders (KOLs) in aesthetic dermatology.
 
“The CellFX System offers a unique non-thermal mechanism that in my experience can clear epidermal and mid-dermal cellular structures without damaging the non-cellular dermal collagen, which can lead to remarkable improvements in common skin problems that I see every day,” said Brian Zelickson, M.D., founder and medical director, Zel Skin and Laser Specialists in Edina, Minn. “We look forward to adding the CellFX System to our practice and foresee a promising future of new applications for this versatile technology platform.”
 
The CellFX System is a multi-application platform that harnesses the company’s proprietary NPS technology delivering nano-second pulses of electrical energy to non-thermally clear cells while sparing adjacent noncellular tissue. NPS technology provides the ability to clear unwanted cellular structures while limiting collateral damage to the surrounding healthy skin, resulting in the potential to clear cellular skin structures with aesthetically pleasing outcomes.
 
 

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