This first commercial use of the CellFX System marks the initiation of the Company’s controlled launch program with product shipments to respected leaders in dermatology in the U.S. and in Europe
The CellFX System for cellular-based skin conditions. (Credit: Pulse Biosciences)
Pulse Biosciences, Inc. (Nasdaq: PLSE), a novel bioelectric medicine company progressing Nano-Pulse Stimulation™ (NPS™) technology, today announced that the first clinic patients have been treated with the CellFX® System.
This first commercial use of the CellFX System marks the initiation of the Company’s controlled launch program with product shipments to respected leaders in dermatology in the U.S. and in Europe.
As the first-of-its-kind multi-application platform powered by NPS technology delivering nano-second pulses of electrical energy to non-thermally clear cells while protecting adjacent non-cellular healthy tissue, the CellFX System represents an advanced, next-generation modality for dermatology procedures addressing common skin conditions.
“I am thrilled and honored to perform the first commercial CellFX procedure worldwide. Building on our positive clinical research, it is most gratifying to be the first dermatologist to offer my everyday patients a better option to clear a variety of benign lesions,” said Dr. Munavalli, medical director of Dermatology, Laser & Vein Specialists of the Carolinas and Clinical Assistant Professor, Department of Dermatology at Wake Forest University School of Medicine. “With its innovative cell-focused NPS mechanism, I see great versatility with the CellFX System in addressing a wide range of unwanted spots, bumps, and growths, especially on the face. I believe the CellFX procedure will open new doors for patients seeking an improved treatment experience that is safe and well-tolerated.”
The prevalence of benign cellular skin disorders among patients visiting aesthetic dermatologists today is widespread. Based on a 2019 survey of U.S. dermatologists and patients, on average several hundred patients per month who visit aesthetic dermatology practices present with bothersome skin conditions. The survey reported that patients place greater value on a procedure to treat cellular skin conditions over other popular aesthetic procedures they currently receive. These patients are also willing to pay cash to treat multiple skin issues in a single visit.1
“We are excited to announce the start of our controlled launch program and the first ever commercial use of the CellFX System. The introduction of this differentiated procedure gives physicians a new non-thermal, cellular-specific mechanism that is expected to greatly advance how even the most common and frustrating skin conditions are treated,” said Ed Ebbers, Executive Vice President and General Manager, Dermatology, of Pulse Biosciences. “We are pleased with the early interest in the CellFX procedure and are now focused on proceeding with our measured rollout among key opinion leaders in the U.S. and the European Union.”
“The ability to execute our controlled launch program simultaneously in two geographies within weeks of their respective regulatory clearances is a testament to the exceptional preparation by our entire organization,” adds Darrin Uecker, President and CEO, of Pulse Biosciences. “I want to thank all our team members and external partners for ushering in an exciting next chapter for Pulse Biosciences. I especially thank Dr. Munavalli for his invaluable contributions to the advancement of NPS technology that have culminated in our controlled launch. We are honored and grateful to have him spearhead the introduction of the CellFX System to the aesthetic dermatology community.”
Source: Company Press Release