Core Viewpoint - Outset Medical, Inc. is facing significant legal and operational challenges following a series of adverse events related to FDA communications and financial performance, leading to a class action lawsuit by investors [1][7]. Group 1: Legal Proceedings - Investors are reminded of the October 28, 2024 deadline to file a lead plaintiff motion in the class action lawsuit concerning Outset Medical securities purchased between August 1, 2022, and August 7, 2024 [1][9]. - The class action alleges that the company made materially false and misleading statements regarding its business operations and failed to disclose adverse facts, particularly concerning the FDA's stance on its Tablo products [7]. Group 2: FDA Warnings and Financial Impact - On July 7, 2023, Outset Medical received a Warning Letter from the FDA, which indicated that certain materials promoted uses outside the approved indications for the Tablo Hemodialysis System, resulting in a stock price drop of $1.20 (5.9%) [3]. - Following a press release on August 2, 2023, announcing a shipment pause for the TabloCart pending 510(k) clearance, the stock price fell by $1.97 (10.18%) [4]. - The company reported on October 12, 2023, that revenue growth was significantly impacted by the FDA's warning letter, leading to a stock price decline of $3.38 (49.9%) [5]. - On August 7, 2024, Outset Medical disclosed second quarter 2024 financial results that missed consensus estimates and lowered its full-year revenue guidance by $39 million, causing a stock price drop of $2.33 (68.53%) [6]. Group 3: Operational Challenges - The company indicated a need for restructuring its sales team and processes to improve execution, which was necessary due to the inability to meet previously forecasted sales ramp for the TabloCart [6].

SAN DIEGO, Sept. 04, 2024 (GLOBE NEWSWIRE) -- Robbins LLP reminds investors that a shareholder filed a class action on behalf of all persons and entities that purchased or otherwise acquired Outset Medical, Inc. (NASDAQ: OM) securities between August 1, 2022 and August 7, 2024. 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. For more information, submit a form, email attorney A ...

Investors can contact the law firm at no cost to learn more about recovering their losses LOS ANGELES, Sept. 03, 2024 (GLOBE NEWSWIRE) -- The Portnoy Law Firm advises Outset Medical, Inc. ("Outset" or the "Company") (NASDAQ:OM) investors of a class action representing investors that bought securities between Aug. 1, 2022 and Aug. 7, 2024, inclusive (the "Class Period"). Outset investors have until Oct. 28, 2024 to file a lead plaintiff motion. Investors are encouraged to contact attorney Lesley F. Portnoy, ...

Core Viewpoint - A class action lawsuit has been filed against Outset Medical, Inc. for alleged violations of securities laws, specifically related to misleading statements about its Tablo products [1][4]. Group 1: Lawsuit Details - The lawsuit is based on claims that Outset made false and misleading statements regarding its Tablo products, which were marketed for continuous renal replacement therapy without FDA approval [4]. - The class period for the lawsuit is defined as from August 1, 2022, to August 7, 2024, during which investors are encouraged to participate if they suffered losses [2]. - The Schall Law Firm is representing investors and has not yet certified the class, meaning potential participants are not currently represented by an attorney [3]. Group 2: Company Operations - Outset is expected to submit a 510(k) application to the FDA for its Tablo products, but sales are likely to be halted until this application is approved [4]. - The company reportedly lacks the sales force necessary to effectively ramp up sales of the Tablo products, contributing to the misleading nature of its public statements [4]. - The revelation of the truth about Outset's operations has led to investor damages, indicating a significant impact on the company's market perception [4].

Core Viewpoint - A class action lawsuit has been filed against Outset Medical, Inc. for alleged violations of federal securities laws related to misleading statements about the company's products and operations [1][2][3]. Group 1: Lawsuit Details - The lawsuit seeks to recover damages for all individuals and entities that purchased Outset Medical securities between August 1, 2022, and August 7, 2024 [2]. - Allegations include that Outset Medical made materially false statements regarding the Tablo products, including marketing for unapproved uses and lacking the necessary sales infrastructure [3]. Group 2: Next Steps for Investors - Investors who suffered losses in Outset Medical have until October 28, 2024, to request to be appointed as lead plaintiff in the case [4]. - A copy of the Complaint can be reviewed on the law firm's website [4]. Group 3: Legal Representation - The law firm operates on a contingency fee basis, meaning they will only collect fees if the case is successful [5]. - Bronstein, Gewirtz & Grossman, LLC has a history of recovering significant amounts for investors in securities fraud cases [6].

SAN FRANCISCO, Aug. 31, 2024 (GLOBE NEWSWIRE) -- Hagens Berman Outset Medical (NASDAQ: OM) investors who suffered substantial losses to submit your losses now. The firm also encourages persons with knowledge who may assist the investigation to contact its attorneys. Class Period: Aug. 1, 2022 – Aug. 7, 2024 Lead Plaintiff Deadline: Oct. 28, 2024 Visit: www.hbsslaw.com/investor-fraud/om Contact the Firm Now: OM@hbsslaw.com 844-916-0895 Outset Medical, Inc. (OM) Securities Class Action: The litigation focuses ...

NEW YORK, Aug. 31, 2024 /PRNewswire/ -- Rosen Law Firm, a global investor rights law firm, announces the filing of a class action lawsuit on behalf of purchasers of securities of Outset Medical, Inc. (NASDAQ: OM) between August 1, 2022 and August 7, 2024, both dates inclusive (the "Class Period"). A class action lawsuit has already been filed. If you wish to serve as lead plaintiff, you must move the Court no later than October 28, 2024. So What: If you purchased Outset Medical securities during the Class P ...

NEW YORK, Aug. 30, 2024 (GLOBE NEWSWIRE) -- Bragar Eagel & Squire, P.C., a nationally recognized stockholder rights law firm, announces that a class action lawsuit has been filed against Outset Medical, Inc. ("Outset Medical" or the "Company") (NASDAQ: OM) in the United States District Court for the Northern District of California on behalf of all persons and entities who purchased or otherwise acquired Outset Medical securities between August 1, 2022 and August 7, 2024, both dates inclusive (the "Class Per ...

NEW YORK, Aug. 30, 2024 (GLOBE NEWSWIRE) -- Gainey McKenna & Egleston announces that a securities class action lawsuit has been filed in the United States District Court for the Northern District of California on behalf of all persons or entities who purchased or otherwise acquired Outset Medical, Inc. ("Outset Medical" or the "Company") (NYSE: OM) securities between August 1, 2022 and August 7, 2024, inclusive (the "Class Period"). The lawsuit seeks to recover damages for the Company's investors under the ...

ATLANTA, Aug. 30, 2024 (GLOBE NEWSWIRE) -- A shareholder class action lawsuit has been filed against Outset Medical, Inc. ("Outset Medical" or "the Company") (NASDAQ: OM). The lawsuit alleges that Defendants made materially false and/or misleading statements and/or failed to disclose material adverse facts about the Company's business, operations, and prospects, including allegations that: (1) the Tablo products were marketed for continuous renal replacement therapy, which is not one of the indications appr ...