HAYWARD, Calif.--(BUSINESS WIRE)--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.”
About Pulse Biosciences®
Pulse Biosciences is a novel bioelectric medicine company committed to health innovation that has the potential to improve the quality of life for patients. The CellFX® System is the first commercial product to harness the distinctive advantages of the Company’s proprietary Nano-Pulse Stimulation™ (NPS™) technology, such as the ability to non-thermally clear cells while sparing non-cellular tissue, to treat a variety of applications for which an optimal solution remains unfulfilled. Nano-Pulse Stimulation technology delivers nano-second pulses of electrical energy. The initial commercial use of the CellFX System is to address a range of dermatologic conditions that share high demand among patients and practitioners for improved dermatologic outcomes. Designed as a multi-application platform, the CellFX System offers customer value with a utilization-based revenue model. To learn more, please visit pulsebiosciences.com.
To stay informed about the CellFX System, please visit CellFX.com and sign up for updates.
Pulse Biosciences, CellFX, Nano-Pulse Stimulation, NPS and the stylized logos are among the trademarks and/or registered trademarks of Pulse Biosciences, Inc. in the United States and other countries.
1 2019 Physician (n=304) and Patient (n=405) surveys conducted by third-party market research firm on behalf of Pulse Biosciences, Inc.
All statements in this press release that are not historical are forward-looking statements, including, among other things, statements relating to Pulse Biosciences’ expectations regarding regulatory clearance and the timing of regulatory filings or approvals, NPS technology including the effectiveness of such technology, the CellFX System including the benefits of the CellFX System and commercialization and adoption of the CellFX System, current and planned future clinical studies and the ability of the Company to execute such studies and results of any such studies, other matters related to its pipeline of product candidates, the Company’s market opportunity and commercialization plans, including the timing and results of the controlled launch in the US, the market for the treatment of certain lesions, the experience of using the CellFX System, future financial performance, and other future events. These statements are not historical facts but rather are based on Pulse Biosciences’ current expectations, estimates, and projections regarding Pulse Biosciences’ business, operations and other similar or related factors. Words such as “may,” “will,” “could,” “would,” “should,” “anticipate,” “predict,” “potential,” “continue,” “expects,” “intends,” “plans,” “projects,” “believes,” “estimates,” and other similar or related expressions are used to identify these forward-looking statements, although not all forward-looking statements contain these words. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties, and assumptions that are difficult or impossible to predict and, in some cases, beyond Pulse Biosciences’ control. Actual results may differ materially from those in the forward-looking statements as a result of a number of factors, including those described in Pulse Biosciences’ filings with the Securities and Exchange Commission. Pulse Biosciences undertakes no obligation to revise or update information in this release to reflect events or circumstances in the future, even if new information becomes available.