Pulse Biosciences : FDA Didn't Accept 510(k) Submission On Sebaceous Hyperplasia Treatment

(RTTNews) - Pulse Biosciences Inc. (PLSE), in an update to its recent FDA 510(k) submission to add the specific indication for treatment of sebaceous hyperplasia to expand the CellFX System's current labeling, said the FDA indicated in a letter on February 5 that the agency did not believe the company provided sufficient clinical evidence at this time to support the expanded indication for use.

In Tuesday regular trading, PLSE was trading at $7.80 down $3.05 or 28.13%.

The FDA stated that the company had not met the primary endpoints of the sebaceous hyperplasia FDA-approved IDE study.

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.

The company anticipates meeting with the FDA to discuss the contents of the 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 take place in the first-quarter 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.