BENSALEM, Pa.–(BUSINESS WIRE)–Law Offices of Howard G. Smith reminds investors of the upcoming September 6, 2022 deadline to file a lead plaintiff motion in the case filed on behalf of investors who purchased Outset Medical, Inc. (“Outset” or the “Company”) (NASDAQ: OM) common stock between September 15, 2020 and June 13, 2022, inclusive (the “Class Period”).
Investors suffering losses on their Outset investments are encouraged to contact the Law Offices of Howard G. Smith to discuss their legal rights in this class action at 888-638-4847 or by email to email@example.com.
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.
If you purchased or otherwise acquired Outset common stock 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 if you meet certain legal requirements. To be a member of the class action 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 action. If you wish to learn more about this class action, or if you have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Howard G. Smith, Esquire, of Law Offices of Howard G. Smith, 3070 Bristol Pike, Suite 112, Bensalem, Pennsylvania 19020, by telephone at (215) 638-4847, toll-free at (888) 638-4847, or by email to firstname.lastname@example.org, or visit our website at www.howardsmithlaw.com.
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