Pulse Biosciences Inc (NASDAQ:PLSE) shares are tumbling after announcing an update to its recent FDA 510(k) submission to add sebaceous hyperplasia to expand the CellFX System's current labeling.
- The Company received an Additional Information (AI) letter, stating that the Company did not provide sufficient clinical evidence for the expanded use of the system.
- The letter also notes 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.
- Based on FDA guidance, the Company believes its meeting with the FDA will be in Q1 2022.
- In Europe, the CellFX System is approved for sebaceous hyperplasia, seborrheic keratosis, and non-genital warts.
- In the U.S., the CellFX System is cleared for dermatologic procedures requiring ablation and resurfacing of the skin and treating benign lesions.
- Price Action: PLSE shares are down 33.3% at $7.24 during the market session on the last check Tuesday.
