SAN DIEGO, Sept. 09, 2024 (GLOBE NEWSWIRE) — A class action lawsuit has been filed on behalf of purchasers or acquirers of Outset Medical, Inc. (NASDAQ: OM) (“Outset Medical” or the “Company”) securities between August 1, 2022 and August 7, 2024, inclusive (the “Class Period”), charging the Company and certain senior executives with violations of the federal securities laws (collectively, “Defendants”).
Outset Medical investors have until October 28, 2024 to seek appointment as lead plaintiff of the Outset Medical class action lawsuit.
If you purchased or otherwise acquired Outset Medical securities between August 1, 2022 and August 7, 2024, and suffered substantial losses, and you wish to obtain additional information or serve as lead plaintiff in this lawsuit, you may submit your information and contact us here: https://dicellolevitt.com/securities/outset-medical/.
You can also contact DiCello Levitt attorneys Brian O’Mara or Hani Farah by calling (888) 287-9005 or at investors@dicellolevitt.com. Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased or acquired.
No Class Has Been Certified. Until a class is certified, you are not represented by counsel unless you retain one. You may select counsel of your choice.
Case Allegations
Outset Medical is a medical technology company focused on transforming the dialysis experience. The Company’s flagship products, Tablo Hemodialysis System (the “Tablo System”), a dialysis machine, and TabloCart, an accessory to the Tablo System, are designed to simplify and reduce the costs of dialysis treatments.
The Outset Medical lawsuit alleges that Defendants made materially false or misleading statements concerning the Company’s business operations and revenue growth prospects, specifically those related to the Tablo System and TabloCart. For example, in July 2022, the Company announced the Tablo System received Section 510(k) clearance from the U.S. Food and Drug Administration (“FDA”) “for use in patients with acute and/or chronic renal failure, with or without filtration, in an acute or chronic care facility” and “in the home.”
The truth began to emerge on July 7, 2023, when Outset Medical disclosed it had received a Warning Letter from the FDA asserting that the Company was marketing the TabloCart with prefiltration, which “requires prior 510(k) clearance” from the FDA that it did not have under its existing 510(k). On this news, the price of Outset Medical stock fell nearly 6%, according to the complaint.
Then, on August 2, 2023, Outset Medical announced it was pausing shipments of “TabloCart with Prefiltration Pending 510(k) Clearance.” On this news, the price of Outset Medical stock fell more than 10%.
On October 12, 2023, Outset Medical revealed disappointing third quarter 2023 and full year 2023 guidance, citing “a larger-than-expected impact in the field from the recent FDA warning letter.” On this news, the price of Outset Medical stock fell nearly 50%.
Finally, on August 7, 2024, Outset Medical released disappointing second quarter 2024 financial results and lowered its full year 2024 revenue guidance by $39 million, explaining the Company would take “clear steps to improve our execution” including “sales team and process restructuring[]”and would not meet its previous sales forecast of TabloCart. On this news, the price of Outset Medical stock fell nearly 69%.
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