The Complaint alleges that throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations, and prospects. Specifically, the Complaint alleges Defendants failed to disclose to investors: (1) that the IDE study evaluating the use of the CellFX System to treat sebaceous hyperplasia lesions failed to meet its primary endpoints; (2) that, as a result, there was a substantial risk that the FDA would reject Pulse’s 510(k) submission seeking to expand the label for the CellFX System to treat sebaceous hyperplasia lesions; and (3) that, as a result of the foregoing, Defendants’ positive statements about the Company’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis.