Outset Medical, Inc. is a medical technology company. Its primary products are the Tablo series devices used in dialysis care, including the Tablo Hemodialysis System and the TabloCart.

An underlying federal securities class action complaint alleges that, Outset Medical, through certain of its officers and directors, 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) the Tablo products were marketed for continuous renal replacement therapy, which is not one of the indications approved by the FDA; (2) that, as a result, Outset Medical was reasonably likely to submit an additional 510(k) application for the Tablo products; (3) that there was a substantial risk that the Company would cease sales of the Tablo products pending FDA approval of additional indications; (4) that Outset Medical lacked the sales team and process to execute on the ramp of Tablo sales; (5) that, as a result of the foregoing, the Company’s revenue growth would be adversely impacted; and (6) 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.

Current Outset Medical shareholders who have continuously held Outset Medical shares since prior to August 1, 2022, can seek corporate reforms, the return of funds back to company coffers, and a court approved incentive award at no cost to them.

If you would like to learn more about this matter at no cost to you, you are encouraged to contact Joshua H. Grabar  at [email protected] or Mia R. Heller at [email protected], or call 267-507-6085.