LOS ANGELES–(BUSINESS WIRE)–Glancy Prongay & Murray LLP (“GPM”), a leading national shareholder rights law firm, announces that a class action lawsuit has been filed on behalf of investors who purchased or otherwise acquired Outset Medical, Inc. (“Outset” or the “Company”) (NASDAQ: OM) common stock between September 15, 2020 and June 13, 2022, inclusive (the “Class Period”). Initial investors have up to September 6, 2022 to file a petition of the main plaintiff.
If you have suffered a loss on your Outset investments or would like to inquire about possible claims to recover your loss under federal securities laws, you may submit your contact information at www.glancylaw.com/ cases/outset-medical-inc/. You may also contact Charles H. Linehan of GPM at 310-201-9150, toll-free at 888-773-9224, or by email at [email protected] to learn more about your rights.
On May 4, 2022, after the market closed, Outset disclosed disappointing results for the first quarter of 2022, including a net loss of $35.9 million. Analysts attributed the results to the unproven reliability of the company’s Tablo hemodialysis system (“Tablo”) for patients with kidney failure.
On this news, Outset’s stock fell $16.88, or 42.3%, over the next three consecutive trading days, to close at $23.06 per share on May 9, 2022, hurting Investors.
Then, on June 13, 2022, Outset announced that it had implemented “a shipping hold on the distribution of its Tablo hemodialysis system for home use pending” review and approval of an application. 510(k) by the United States Food and Drug Administration (“FDA”). The company withdrew its earlier guidance and forecast revenue of at least $25 million for the second quarter of 2022 due to the suspension of shipments. Despite prior assurances that the company was conducting its study under FDA protocols requiring “real-world data” collected in the “home environment,” its chief executive also revealed that he “ran with a protocol that involves a simulated operating environment in a human factors laboratory.
On this news, Outset’s stock fell $6.95, or 34.1%, to close at $13.46 per share on June 14, 2022, further hurting investors.
The Complaint filed in this action alleges that, throughout the Class Period, the Defendants made materially false and/or misleading statements, and failed to disclose material adverse facts regarding the business, operations and societal prospects. Specifically, the Defendants failed to disclose that: (1) the Defendants had “continually made improvements and updates to Tablo over the time since its initial authorization” that required an additional 510(k) application; (2) as a result, the Company was unable to conduct a human factors study on a device cleared under FDA protocols; (3) the Company’s failure to complete the human factors study exposed the Company to the likelihood of the FDA imposing a “suspension of shipment” and marketing suspension, leaving the Company unable to sell the Tablo for home use; and (4) as a result of the foregoing, defendants’ positive statements about the company’s business, operations and prospects were materially false and misleading and/or lacked a reasonable basis at all relevant times.
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If you purchased or otherwise acquired shares of Outset common stock during the Class Period, you may sue the Court no later than September 6, 2022 ask the Tribunal to appoint you as the principal plaintiff. To be a member of the Group, you do not have to perform any action at the moment; you can retain the services of a lawyer of your choice or take no action and remain an absent member of the Class. If you would like to know more about this action, or if you have any questions about this announcement or your rights or interests in respect of these matters, please contact Charles Linehan, Esquire, of GPM, 1925 Century Park East, Suite 2100, Los Angeles California 90067 at 310-201-9150, toll free at 888-773-9224, by email at [email protected], or visit our website at www.glancylaw.com. If requesting by email, please include your mailing address, phone number and number of shares purchased.
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