Overview

A class action lawsuit has been filed against Outset Medical, Inc. (“Outset Medical” or the “Company”) (NASDAQ: OM) and certain of the Company’s former and current senior executive officers alleging violations of the federal securities laws.  The Outset Medical class action lawsuit is brought on behalf of all persons and entities who purchased or otherwise Outset Medical securities between August 1, 2022, and August 7, 2024, both dates inclusive (the “Class Period”).  Investors have until October 28, 2024, to seek appointment as lead plaintiff of the Outset Medical class action lawsuit.

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 Tablo Hemodialysis System is a dialysis machine.  The TabloCart is an accessory to Tablo Hemodialysis System.  On July 29, 2022, the Company received Section 510(k) clearance from the U.S. Food and Drug Administration (“FDA”) for the Tablo Hemodialysis System as “indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute or chronic care facility” and “in the home.”

The Outset Medical class action lawsuit alleges that Defendants, throughout the Class Period, 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, 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) 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.

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If you purchased or otherwise acquired Outset Medical securities between August 1, 2022, and August 7, 2024, both dates inclusive, and you wish to serve as lead plaintiff in this lawsuit, we encourage you to submit your information to DiCello Levitt LLP via the form on this page. 

You can also contact DiCello Levitt partner Brian O’Mara by calling (888) 287-9005 or at [email protected]. 

The deadline to apply to the Court to serve as a lead plaintiff in the Outset Medical class action lawsuit is October 28, 2024.