Robbins LLP is Investigating Allegations that Outset Medical, Inc. (OM) Misled Investors Regarding its Business Prospects

Robbins LLP informs investors that a shareholder filed a class action on behalf of all persons and entities that purchased or otherwise acquired Outset Medical, Inc. (NASDAQ: OM) securities between August 1, 2022 and August 7, 2024. Outset Medical 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.

The Allegations

According to the complaint, during the class period, 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 the on 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.

Plaintiff alleges that on August 7, 2024, after the market closed, Outset Medical released its second quarter 2024 financial results, significantly missing consensus estimates and lowering its full year 2024 revenue guidance by $39 million at the midpoint. The Company disclosed it would be forced to take “clear steps to improve our execution” including “sales team and process restructuring.”  As a result, the Company disclosed it would be unable to deliver on a post-approval sales ramp of TabloCart previously forecast.  On this news, the Company’s share price fell $2.33, or 68.53%, to close at $1.07 per share on August 8, 2024, on unusually heavy trading volume.

What Now: You may be eligible to participate in the class action against Outset Medical, Inc. Shareholders who want to serve as lead plaintiff for the class must submit their application to the court by October 28, 2024. A lead plaintiff is a representative party who acts 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. If you choose to take no action, you can remain an absent class member.

All representation is on a contingency fee basis. Shareholders pay no fees or expenses.