Outset Medical, Inc. (NASDAQ: OM)

This investigation is for anyone who acquired securities in Outset Medical, Inc. (NASDAQ: OM) from November 8, 2022 through October 12, 2023.

The Law Offices of Howard G. Smith believes that the Company and certain of its executives violated federal law. Specifically, the Law Offices of Howard G. Smith believes that, throughout the time period mentioned above, the Company misled investors regarding its financial condition. More specifically, the Law Offices of Howard G. Smith believes that the Company misled investors by telling investors that the Company was acting according to the law when, in fact, the Company was promoting its dialysis treatment for continuous renal replacement therapy when the FDA had not approved the treatment for that purpose.

On July 7, 2023, Outset Medical disclosed that it had received a Warning Letter from the United States Food and Drug Administration (“FDA”) which “assert[ed] that certain materials reviewed by the FDA and found on the Company’s website promote continuous renal replacement therapy (CRRT), a modality outside of the current indications for the Tablo Hemodialysis System” and that “the TabloCart with Prefiltration . . . requires prior 510(k) clearance for marketing authorization.” On this news, the price of the Company’s stock dropped precipitously on unusually heavy trading volume. Then, on August 2, 2023, after market hours, Outset announced that it had paused the shipment of TabloCart with Prefiltration, pending the FDA’s 510(k) clearance. The Company also stated that it now expects its 2023 revenue to be at the low end of its previously projected range of $144 to $150 million as a result of the shipment pause. On this news, the price of the Company’s stock again dropped precipitously on unusually heavy trading volume. Finally, on October 12, 2023, after the market closed, healthcare company Novo Nordisk announced that one of its diabetes treatments could also be used to treat chronic kidney disease. On this news, the price of the Company’s stock again dropped precipitously on unusually heavy trading volume.

The Law Offices of Howard G. Smith seeks to recover damages on behalf of class members. If you acquired securities in Outset Medical, Inc. (NASDAQ: OM) from November 8, 2022 through October 12, 2023 you may join the lawsuit by submitting your information online, or you may call the Law Offices of Howard G. Smith and speak to Mr. Smith directly to learn how he can protect your rights.