Bioelectric medicine company Pulse Biosciences has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its CellFX system.
The clearance enables the indication of the system to be extended to include sebaceous hyperplasia treatment for patients with Fitzpatrick skin types I-III.
The approval was granted based on clinical data from the firm’s investigational device exemption (IDE)-approved trial for sebaceous hyperplasia treatment.
Recently, Pulse Biosciences secured 510(k) approval from the regulatory agency for two more treatment tips with larger spot sizes, specifically the 7.5mm and 10mm tip sizes, to treat larger benign lesions.
The company already offered tip sizes of 1.5mm, 2.5mm and 5.0mm for treatments.
The CellFX system is claimed to be the first commercial product to take advantage of the company’s Nano-Pulse Stimulation (NPS) technology for the treatment of several conditions.
It is designed as a multi-application platform to offer a utilisation-based revenue approach for customers.
Pulse Biosciences president and CEO Kevin Danahy said: “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.
“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 endeavour to offer the benefits of NPS technology to more patients.”
Providing nano-second pulses of electrical energy to non-thermally clear cells, the firm’s NPS technology avoids adjacent non-cellular tissue.
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