Pulse Biosciences Announces FDA IDE Approval and Initiation of Sebaceous Hyperplasia Study
Pulse Biosciences, Inc. (Nasdaq: PLSE), a novel bioelectric medicine company progressing Nano-Pulse Stimulation (NPS) technology, today announced FDA Investigational Device Exemption (IDE) approval and initiation of a pivotal study to evaluate the treatment of sebaceous hyperplasia (SH) lesions using the CellFX System.
- Pulse Biosciences, Inc. (Nasdaq: PLSE), a novel bioelectric medicine company progressing Nano-Pulse Stimulation (NPS) technology, today announced FDA Investigational Device Exemption (IDE) approval and initiation of a pivotal study to evaluate the treatment of sebaceous hyperplasia (SH) lesions using the CellFX System.
- Following IDE approval, several patients have been enrolled, with the first patient procedure completed on September 28, 2020.
- We are pleased to have received FDA IDE approval and to have begun this important SH comparative study slightly ahead of the fourth quarter start we had previously communicated.
- Pulse Biosciences, CellFX, Nano-Pulse Stimulation, NPS and the stylized logos are among the trademarks and/or registered trademarks of Pulse Biosciences, Inc. in the United States and other countries.