NEW YORK, Oct. 9, 2024 /PRNewswire/ -- Pomerantz LLP announces that a class action lawsuit has been filed against Outset Medical, Inc.  ("Outset Medical" or the "Company") (NASDAQ: OM).  Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, (or 888.4-POMLAW), toll-free, Ext. 7980. Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased.

The class action concerns whether Outset Medical and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.

You have until October 28, 2024, to ask the Court to appoint you as Lead Plaintiff for the class if you are a shareholder who purchased or otherwise acquired Outset Medical securities during the Class Period. A copy of the Complaint can be obtained at www.pomerantzlaw.com.

[Click here for information about joining the class action]

On July 7, 2023, Outset Medical disclosed that it had received a Warning Letter from the FDA which "asserted that certain materials . . . promote continuous renal replacement therapy (CRRT), a modality outside of the current indications for the Tablo Hemodialysis System" and "assert[ed] that the TabloCart with Prefiltration . . . requires prior 510(k) clearance for marketing authorization."  The Company stated that it would "work collaboratively with the FDA to resolve this observation, including potentially submitting a 510(k) on TabloCart."

On this news, Outset Medical's stock price fell $1.20 per share, or 5.9%, to close at $19.26 per share on July 10, 2023.

Then, on August 2, 2023, Outset Medical issued a press release announcing a "Shipment Pause of TabloCart with Prefiltration Pending 510(k) Clearance."

On this news, Outset Medical's stock price fell $1.97 per share, or 10.18%, to close at $17.39 per share on August 3, 2023.

On October 12, 2023, Outset Medical issued a press release announcing preliminary third quarter 2023 financial results, as well as updated financial guidance for 2023 revenue, which reflected that "[g]rowth in the quarter was dampened by a larger-than-expected impact in the field from the recent FDA warning letter."

On this news, Outset Medical's stock price fell $3.38 per share, or 49.9%, to close at $3.39 per share on October 13, 2023.

Finally, on August 7, 2024, Outset Medical reported 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 that it would be forced to take "clear steps to improve our execution" including "sales team and process restructuring."  As a result, the Company stated that it would be unable to deliver on a post-approval sales ramp of TabloCart previously forecast.

On this news, Outset Medical's stock price fell $2.33 per share, or 68.53%, to close at $1.07 per share on August 8, 2024.

Pomerantz LLP, with offices in New York, Chicago, Los Angeles, London, Paris, and Tel Aviv, is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions. Today, more than 85 years later, Pomerantz continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered billions of dollars in damages awards on behalf of class members. See www.pomlaw.com.

Attorney advertising. Prior results do not guarantee similar outcomes.

CONTACT:

Danielle Peyton

Pomerantz LLP

dpeyton@pomlaw.com

646-581-9980 ext. 7980

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SOURCE Pomerantz LLP