Pulse Biosciences, Inc. (PLSE) Misstated the Viability of its CellFX System for Treating Sebaceous Hyperplasia Lesions
A shareholder filed a class action on behalf of persons and entities that purchased or otherwise acquired Pulse securities between January 21, 2021 and February 7, 2022, for violations of the Securities Exchange Act of 1934. Pulse is a bioelectric medicine company. Its only commercial product is the CellFX System, which uses the Company’s proprietary Nano-Pulse Stimulation technology to treat a variety of applications.
According to the complaint, in February 2021, Pulse received clearance from the U.S. Food and Drug Administration (“FDA”) of the CellFX System for dermatologic procedures requiring ablation and resurfacing of the skin.
In October 2020, Pulse initiated a study to evaluate the treatment of sebaceous hyperplasia lesions using the CellFX System. Pulse intended to use the data from the study to support a 510(k) submission to expand the indication for use of the CellFX System to treat sebaceous hyperplasia lesions.
On February 8, 2022, Pulse announced that the FDA concluded there was insufficient clinical evidence to support the Company’s 510(k) submission to expand the label for the CellFX System to treat sebaceous hyperplasia. On this news, the Company’s share price fell $3.74, or over 34%, to close at $7.12 per share on February 8, 2022.
Next Steps: If you acquired shares of Pulse Biosciences, Inc. (PLSE) between January 21, 2021 and February 7, 2022, you have until April 18, 2022, to ask the court to appoint you lead plaintiff for the class. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation. You do not have to participate in the case to be eligible for a recovery.
All representation is on a contingency fee basis. Shareholders pay no fees or expenses.
