Then, after the markets closed on June 13, 2022, Outset Medical announced that the FDA had forced the Company to hold all shipments of Tablo for use in the home until Tablo received proper regulatory clearance. In response to this disclosure, and as the market digested this news, the price of Outset Medical common stock declined more than 40% over the three trading days that followed, from a closing price of $39.94 per share on Wednesday, May 4, 2022, to a closing price of $23.06 per share on Monday, May 9, 2022. The truth began to emerge on May 5, 2022, when the Company announced disappointing results for the first quarter of 2022, which analysts attributed, inter alia, to the untested nature of Tablo in the home setting. The Class Action alleges that, during the Class Period, Defendants misled investors and/or 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 Tablo for home use and (4) as a result, 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.
The Company’s flagship product is the Tablo Hemodialysis System (“Tablo”), a dialysis machine that purifies tap water and then artificially purifies and removes toxins from the blood of patients suffering from kidney failure. Outset Medical is a medical technology company focused on kidney dialysis, the primary treatment for acute and chronic kidney failure. Investors have until Septemto apply to the Court to be appointed as lead plaintiff in the lawsuit. (“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 Septemand June 13, 2022, both dates inclusive (the “Class Period”). NEW YORK–(BUSINESS WIRE)– #Action–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.
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