A securities class action has been filed in the USDC — N.D.CA. against Outset Medical, Inc. (OM) (“Outset Medical” or the “Company”), on behalf of all persons or entities that purchased or otherwise acquired Outset Medical securities between August 1, 2022 and August 7, 2024, both dates inclusive (the “Class Period”).
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 United States 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 complaint alleges 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, 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, thereby harming investors.
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