Pulse Biosciences Scores CE Mark for CellFX System

The CellFX System delivers NPS technology to clear hard-to-treat benign skin lesions.

Pulse Biosciences, Inc. received CE mark for the CellFXSystem.

The Company can now proceed with its planned controlled launch of the CellFX System to medical practices within the European Union (EU) for the treatment of general dermatologic conditions, including sebaceous hyperplasia (SH), seborrheic keratosis (SK) and cutaneous non-genital warts. 

The CellFX System is a multi-application platform that harnesses the Company’s proprietary NPS technology which delivers 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 lesions while limiting collateral damage to the surrounding healthy skin, resulting in the potential to clear benign lesions with aesthetically pleasing outcomes.

“We are excited about this major milestone for Pulse Biosciences which keeps us on track to commercialize the CellFX System in the EU this quarter. The CE mark is the first commercial regulatory clearance for the CellFX System and an important validation of the capabilities of NPS technology. Most importantly, it verifies the clinical evidence supporting the beneficial use of the system in these difficult-to-treat lesions. We appreciate all the work and effort from the notified body, scientific investigators and our team that has led to the successful outcome of this process,” says Darrin Uecker, President and Chief Executive Officer of Pulse Biosciences, in a news release. “Our controlled commercial launch in Europe will be conducted by thought-leading aesthetic dermatologists who will further validate and expand the potential of the system. We look forward to working with this group to advance a solution for a significant unmet need while delivering a best-in-class experience.”