Pulse Biosciences (Nasdaq:PLSE) announced today that the FDA granted 510(k) clearance for its CellFx system with expanded indication.
The new indication covers the treatment of sebaceous hyperplasia in patients with Fitzpatrick skin types I-III. Clearance followed positive clinical data from an investigational device exemption (IDE) study of the system.
CellFX uses Pulse Biosciences’ proprietary nano-pulse stimulation (NPS) technology. NPS technology delivers nanosecond pulses of electrical energy to non-thermally clear cells while sparing adjacent non-cellular tissue.
Hayward, California-based Pulse Biosciences said CellFX represents the first commercial product to use NPS technology to treat a variety of conditions. The company is pursuing development in cardiology, oncology, gastroenterology, and other medical specialties.
Pulse Biosciences also received FDA clearance for two additional treatment tips with larger spot sizes. The clearances include 7.5mm and 10mm tip sizes for treating larger benign lesions. The company said this broadens its portfolio, which previously featured 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 CEO 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.”