The U.S. Food and Drug Administration (FDA) has cleared Pulse Biosciences' CellFX, which uses Nano-Pulse Stimulation (NPS) technology, to treat dermatologic conditions requiring ablation and resurfacing of the skin. The company is planning a controlled commercial launch of the technology in the U.S. in the coming weeks, with a focus on medical aesthetic providers.
Related: CellFX Receives CE Mark
“The CellFX System offers a unique nonthermal 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, MD, founder and medical director, Zel Skin and Laser Specialists in Edina, Minnesota. “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 nonthermally 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.
“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 U.S. 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.”