Lead Plaintiff Deadline: September 12, 2021 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.įor more information on the Outset Medical class action go to:Ĭlass Period: Pursuant to the Company's JIPO While performing further regulatory studies during the Class Period, the Company assured investors that it was conducting the studies“in accordance with the FDA approved protocol,” which required an appropriate demonstration of“real-world” human testing given that the device would be used at home by non-professionals. Devices used by non-professionals outside of a clinical setting and that can present serious health consequences like Tablo are subject to heightened scrutiny by the FDA, including post-market surveillance studies pursuant to the FDCA. Throughout the Class Period, Outset Medical touted that Tablo can“serve as a dialysis clinic on wheels” that had been“cleared by the Food and Drug Administration for use in the hospital, clinic or home setting” under Section 510(k) of the Federal Food, Drug, and Cosmetic Act (the“FDCA”). During an“FDA Review Call” held that day with analysts, the Defendants acknowledged the“ship hold” had already been in place for weeks before investors were provided this material information, and that as a result of the shipment hold, the Company was“suspending our prior full-year and long-term guidance.” On this news, the price of Outset Medical stock fell an additional 33%, from a closing price of $20.41 per share on June 13, 2022, to a closing price of $13.46 per share on June 14, 2022. 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 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. Lead Plaintiff Deadline: September 6, 2022 Additional information about each case can be found at the link provided. Stockholders have until the deadlines below to petition the court to serve as lead plaintiff. (NASDAQ: OM), Missfresh Limited (NASDAQ: MF), Molecular Partners AG (NASDAQ: MOLN), and TG Therapeutics, Inc. 21, 2022 (GLOBE NEWSWIRE) - Bragar Eagel & Squire, P.C., a nationally recognized shareholder rights law firm, reminds investors that class actions have been commenced on behalf of stockholders of Outset Medical, Inc.

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