Pulse Biosciences, Inc. Announces Conformité Européene Mark Approval for CellFX® System
January 25, 2021 at 06:30 pm IST
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Pulse Biosciences, Inc. announced Conformité Européene (CE) mark approval for the CellFX® System. The CE mark confirms that the CellFX System meets the requirements of the European Medical Devices Directive. This allows the Company to 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. Controlled launch participants selected from the top aesthetic centers in Europe will receive the first CellFX Systems for commercial use. 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. In the coming weeks, renowned dermatologist Dr. Afschin Fatemi of Dusseldorf, Germany, will receive training on the first commercial CellFX System. The prevalence of SH, SK and common, non-genital warts among patients visiting aesthetic dermatologists is widespread. Based on a 2020 survey among aesthetic physicians from Germany, Spain and France, an average of 200 patients per month who visit aesthetic dermatology practices present with each lesion type (SH, SK, non-genital warts). Further, patients place greater value on the CellFX procedure over other popular aesthetic procedures they currently receive, and are willing to pay cash to treat multiple lesions in a single visit.
Pulse Biosciences, Inc. is a bioelectric medicine company. The Companyâs proprietary CellFX nsPFA technology delivers nanosecond pulses of electrical energy to non-thermally clear cells while sparing adjacent noncellular tissue. The Company is engaged in the development of its CellFX nsPFA technology for use in the treatment of atrial fibrillation and in a select few other markets where it could have a profound positive impact on healthcare for both patients and providers. The Companyâs Nano-pulse Stimulation (NPS) technology is an energy modality that delivers nanosecond-duration pulses of electrical energy, each less than a millionth of a second long, to non-thermally clear targeted cells while sparing adjacent noncellular tissue. The Company has designed a variety of applicators, or end-effectors, to explore the potential use of the CellFX platform to treat disorders in other medical specialties, such as cardiology, gastroenterology, gynecology, and ear, nose, and throat.