The Law Offices of Frank R. Cruz announces that a class action lawsuit has been filed on behalf of persons and entities that 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”). Outset investors have until September 6, 2022 to file a lead plaintiff motion.

If you are a shareholder who suffered a loss, click here to participate.

On May 4, 2022, after the market closed, Outset disclosed disappointing results for first quarter 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 kidney failure patients.

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, thereby injuring investors.

Then, on June 13, 2022, Outset announced that it had implemented “a shipment hold on the distribution of its Tablo Hemodialysis System for home use pending” a review and clearance of a 510(k) application by the U.S. Food and Drug Administration (“FDA”). The Company withdrew its prior guidance and expected second quarter 2022 revenue of at least $25 million due to the shipment hold. Despite prior assurances that the Company was conducting its study in accordance with FDA protocols requiring “real-world data” gathered in “the home environment,” its Chief Executive Officer also revealed that it had “run with a protocol that involves a simulated use environment at a human factors lab.”

On this news, Outset’s stock fell $6.95, or 34.1%, to close at $13.46 per share on June 14, 2022, thereby injuring investors further.

The complaint filed in this action alleges that, throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations, and prospects. Specifically, Defendants failed to disclose that: (1) Defendants had “continuously made improvements and updates to Tablo over time since its original clearance” that required an additional 510(k) application; (2) as a result, the Company could not conduct a human factors study on a cleared device in accordance with FDA protocols; (3) the Company’s inability to conduct the human factors study subjected the Company to the likelihood of the FDA imposing a “shipment hold” 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 Outset securities during the Class Period, you may move the Court no later than September 6, 2022 to ask the Court to appoint you as lead plaintiff. To be a member of the Class you need not take any action at this time; you may retain counsel of your choice or take no action and remain an absent member of the Class. If you purchased Outset securities, have information or would like to learn more about these claims, or have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Frank R. Cruz, of The Law Offices of Frank R. Cruz, 1999 Avenue of the Stars, Suite 1100, Los Angeles, California 90067 at 310-914-5007, by email to info@frankcruzlaw.com, or visit our website at www.frankcruzlaw.com. If you inquire by email please include your mailing address, telephone number, and number of shares purchased.

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

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The Law Offices of Frank R. Cruz Announces the Filing of a Securities Class Action on Behalf of Outset Medical, Inc. (OM) Investors