Outset Medical, Inc. Class Action Alert: Wolf Haldenstein Adler Freeman & Herz LLP reminds investors that a securities class action lawsuit has been filed in the United States District Court for the Northern District of California against Outset Medical, Inc.

Upcoming Lead Plaintiff Deadline is October 28, 2024

NEW YORK, Sept. 24, 2024 /PRNewswire/ -- Wolf Haldenstein Adler Freeman & Herz LLP ("Wolf Haldenstein") announces that a federal securities class action lawsuit has been filed Outset Medical, Inc. ("Outset" or the "Company") (NASDAQ: OM ) on behalf of all purchasers of Outset between August 1, 2022 and August 7, 2024, inclusive (the "Class Period")

All investors who purchased shares and incurred losses are advised to contact the firm immediately at classmember@whafh.com or (800) 575-0735 or (212) 545-4774. You may obtain additional information concerning the action or join the case on our website , www.whafh.com.

If you have incurred losses, you may, no later than October 28, 2024, request that the Court appoint you as the lead plaintiff of the proposed class. Please contact Wolf Haldenstein to learn more about your rights.

PLEASE CLICK HERE TO PROVIDE CONTACT AND TRANSACTION INFORMATION

On July 7, 2023, Outset Medical disclosed that it had received a Warning Letter from the United States Food and Drug Administration ("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.

Wolf Haldenstein has experience in the prosecution of securities class actions and derivative litigation in state and federal trial and appellate courts across the country. The firm has attorneys in various practice areas, and offices in New York, Chicago, Nashville and San Diego. The reputation and expertise of this firm in shareholder and other class litigation has been repeatedly recognized by the courts, which have appointed it to major positions in complex securities multi-district and consolidated litigation.

If you wish to discuss this action or have any questions regarding your rights and interests in this case, please immediately contact Wolf Haldenstein by telephone at (800) 575-0735 or via e-mail at classmember@whafh.com.

Contact:
Wolf Haldenstein Adler Freeman & Herz LLP
Gregory Stone, Director of Case and Financial Analysis
Email: gstone@whafh.com or classmember@whafh.com
Tel: (800) 575-0735 or (212) 545-4774

This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.

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SOURCE Wolf Haldenstein Adler Freeman & Herz LLP