The US Food and Drug Administration (FDA) has rejected an application of Pulse Biosciences is seeking expansion to the current labeling of CellFX System to include its use for the treatment of sebaceous hyperplasia.

The bioelectric medicine company said that the FDA issued an additional information (AI) letter stating that it needs more clinical evidence to back the expanded indication for use. Besides, the regulator said that Pulse Biosciences could not meet the primary endpoints of the sebaceous hyperplasia FDA-approved IDE study.

Pulse Biosciences, which had submitted a 510(k) to the FDA for the expanded indication in December 2021, stated: “The Company anticipates meeting with the FDA to discuss the contents of the AI letter and potential next steps, which may require additional clinical data and potentially a new 510(k) submission.”

Currently, the CellFX System is approved by the US for dermatologic procedures needing ablation and resurfacing of the skin and intended use of treatment of benign lesions.

In Europe, the CellFX System has approval for the treatment of sebaceous hyperplasia, non-genital warts, and seborrheic keratosis.

The CellFX System is powered by Pulse Biosciences’ Nano-Pulse Stimulation (NPS) technology, which involves the use of second pulses of electrical energy to clear cells non-thermally while sparing nearby non-cellular tissue.

  CellFX System, Dermatology, non-genital warts, Pulse Biosciences, sebaceous hyperplasia, seborrheic keratosis, US FDA, US Food and Drug Administration, USA