The CellFX system is approved for dermatologic procedures, which need ablation and resurfacing of the skin
The US FDA’s Centre for Devices and Radiological Health. (Credit: The U.S. Food and Drug Administration)
Bioelectric medicine company Pulse Biosciences has secured approval from the US Food and Drug Administration (FDA) for its CellFX system.
The CellFX system has been approved for dermatologic procedures that need ablation and resurfacing of the skin.
The system is a multi-application platform, which uses the firm’s advanced Nano-Pulse Stimulation (NPS) technology to deliver nano-second pulses of electrical energy to non-thermally clear cells while leaving adjacent noncellular tissue.
According to Pulse Biosciences, NPS technology has the potential to clear unwanted cellular structures, while minimising collateral damage to the surrounding healthy skin.
The technology is said to have the capability to result in clear cellular skin structures with aesthetically pleasing outcomes.
The company intends to start a controlled commercial launch in the US with a group of selected key opinion leaders (KOLs) in aesthetic dermatology.
In January, Pulse Biosciences obtained CE mark for the CellFX system to go ahead with its planned controlled launch of the system to medical practices within the European Union (EU).
It was approved for the treatment of general dermatologic conditions, including sebaceous hyperplasia (SH), seborrheic keratosis (SK) and cutaneous non-genital warts.
Pulse Biosciences president and CEO Darrin Uecker said: “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.”
In October 2018, Pulse Biosciences started a clinical feasibility study using its NPS platform to treat patients with cutaneous warts.