FDA Wants Additional Info on Pulse Biosciences 510(k) Submission

 Pulse Biosciences, Inc. (Nasdaq: PLSE), a novel bioelectric medicine company commercializing the CellFX® System powered by Nano-Pulse Stimulation™ (NPS™) technology, today announced an update to its recent U.S. Food and Drug Administration (FDA) 510(k) submission to add the specific indication for treatment of sebaceous hyperplasia to expand the CellFX System’s current labeling.

The Company submitted a 510(k) in December 2021 to add the treatment of sebaceous hyperplasia to the CellFX System’s indications for use in the United States. On February 5, 2022, the Company received an Additional Information ("AI") letter from the FDA in response to the 510(k) submitted. In the AI letter, the FDA stated it did not believe the Company provided sufficient clinical evidence at this time to support the expanded indication for use, and that the Company had not met the primary endpoints of the sebaceous hyperplasia FDA-approved IDE study. 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. The AI letter is a standard part of the 510(k) review process and places the review on hold until the Company responds within 180 days of the request in the AI letter. Based on FDA guidance, the Company believes its meeting with the FDA will take place in Q1 2022.

In Europe, the CellFX System is approved for the treatment of sebaceous hyperplasia, seborrheic keratosis and non-genital warts. In the United States, the CellFX System is cleared for dermatologic procedures requiring ablation and resurfacing of the skin and intended use of treating benign lesions.

https://finance.yahoo.com/news/pulse-biosciences-provides-recent-fda-134500060.html