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, Pulse Biosciences explains in a media release.
“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.
“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.”
— Darrin Uecker, President and Chief Executive Officer of Pulse Biosciences
In the coming weeks, dermatologist Dr. Afschin Fatemi of Dusseldorf, Germany, will receive training on the first commercial CellFX System.
“I am honored to work with Pulse Biosciences and to be the first dermatologist in the world to offer procedures with the CellFX System using Nano-Pulse Stimulation technology. Across our 13 clinics in Germany, we focus on providing our patients the most innovative and effective aesthetic procedures. I see patients with SH, SK and warts often in my practice and am excited to now have an elegant solution to address these cellular-based lesions.”
— Dr. Fatemi, MD, Founder of the S-thetic Group
“In my extensive investigational work with Nano-Pulse Stimulation technology, I am continually impressed by its cellular-focused ability to fully remove lesions that extend into the dermis without permanently damaging the healthy surrounding dermal foundation. I view this as just the beginning of the clinical potential of NPS technology to clear a broad range of challenging benign lesions with a favorable aesthetic outcome and believe the CellFX System using NPS technology could represent a fundamental change in aesthetic dermatology.”
— Girish (Gilly) Munavalli, MD, Medical Director of Dermatology, Laser & Vein Specialists of the Carolinas and member of the Pulse Biosciences Scientific Advisory Board
[Source: Pulse Biosciences]
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