Pulse Biosciences Initiates Pivotal Study Of CellFX System In Sebaceous Hyperplasia

(RTTNews) - Pulse Biosciences Inc.'s (PLSE) CellFX System has received Investigational Device Exemption approval from the FDA and a pivotal study evaluating this device in the treatment of sebaceous hyperplasia lesions has been initiated.

The pivotal study is designed to compare the safety and efficacy of the CellFX System against electrodesiccation procedures in clearing facial sebaceous hyperplasia lesions. About 60 patients across five study sites are expected to be enrolled in the study.

The data generated from this study is intended to support a 510(k) submission to get clearance for use of the CellFX System specifically to treat sebaceous hyperplasia lesions. The company expects to conclude the study in the first quarter of 2021.

Sebaceous hyperplasia is a very common skin condition that presents as shiny, yellowish, or white raised bumps, or lesions, that most frequently occur on the face and are often oily in appearance. These lesions are difficult to treat with current thermal technologies without damaging the skin surface.

In parallel, the company is also working towards submitting the initial CellFX System 510(k) application for a general dermatologic indication in the next several weeks.

PLSE closed Wednesday's trading at $11.79, down 3.60%.