The filed complaint alleges that defendants made false statements and/or concealed that: (1) the Tablo products, its primary devices used in dialysis care, were marketed for continuous renal replacement therapy, which is not one of the indications approved by the FDA; (2) as a result, Outset Medical was reasonably likely to submit an additional 510(k) application for the Tablo products; (3) there was a substantial risk that the Company would cease sales of the Tablo products pending FDA approval of additional indications; (4) Outset Medical lacked the sales team and process to execute on the ramp of Tablo sales; (5) as a result of the foregoing, the Company’s revenue growth would be adversely impacted; and (6) 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.