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Pulse Biosciences Announces FDA 510(k) Clearance for the Treatment of Sebaceous Hyperplasia
September 26, 2022
Pulse Biosciences, Inc. (Nasdaq: PLSE), a novel bioelectric medicine company developing the CellFX® System powered by Nano-Pulse Stimulation™ (NPS™) technology, announced receipt of U.S. Food and Drug Administration (FDA) 510(k) clearance for its CellFX System, expanding the indication for use to include the treatment of sebaceous hyperplasia in patients with Fitzpatrick skin types I-III. This specific indication clearance enhances the CellFX System’s general indication FDA clearance and enables the Company to support clinics in marketing and promoting CellFX treatments specifically for patients with sebaceous hyperplasia. The clearance was based on clinical data from the Company’s IDE approved study for the treatment of sebaceous hyperplasia.
The Company also recently received FDA 510(k) clearance of two additional treatment tips with larger spot sizes, specifically 7.5mm and 10mm tip sizes, for treating larger benign lesions. These treatment tips broaden the portfolio of previously available 1.5mm, 2.5mm and 5.0mm treatment tip sizes.
“We are pleased with the continued advancement of the CellFX System and its capabilities to enhance its value proposition for patients, clinicians and any potential commercial partner. These clearances provide further validation of the system’s strong safety and effectiveness profile,” said Kevin Danahy, President and Chief Executive Officer of Pulse Biosciences. “We would like to thank all of the investigators, the staff at their clinics and the patients who participated in these trials, as well as the FDA for their ongoing collaboration as we endeavor to offer the benefits of NPS technology to more patients.”
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 Company’s proprietary Nano-Pulse Stimulation technology delivers nano-second pulses of electrical energy to non-thermally clear cells while sparing adjacent non-cellular tissue. The CellFX® System is the first commercial product to harness the distinctive advantages of NPS technology to treat a variety of conditions for which an optimal solution remains unfulfilled. The Company is actively pursuing application development in cardiology, oncology, gastroenterology, and other medical specialties. Designed as a multi-application platform, the CellFX System offers customer value with a utilization-based revenue model. Visit www.pulsebiosciences.com to learn more.
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.
See Full Press Release at the Source: Pulse Biosciences Announces FDA 510(k) Clearance for the Treatment of Sebaceous Hyperplasia
Press Release by: Pulse Biosciences
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