![]() ![]() If you purchased Outset Medical common stock during the Class Period and were damaged thereby, you are a member of the “Class” and may be able to seek appointment as lead plaintiff. 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 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. 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”). 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. The Class Action filed by Saxena White is captioned: Plymouth County Retirement Association v. Securities and Exchange Commission Rule 10b-5 promulgated thereunder on behalf of all persons or entities that purchased Outset Medical common stock between Septemand June 13, 2022, inclusive (the “Class Period”), and were damaged thereby (the “Class”). The Class Action asserts claims under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 (the “Exchange Act”) and U.S. (“Outset Medical” or the “Company”) (NASDAQ: OM) and certain of its executive officers (collectively, “Defendants”). has filed a securities fraud class action lawsuit (the “Class Action”) in the United States District Court for the Northern District of California against Outset Medical, Inc. Claim your 1-week free trial to StreetInsider Premium here.īOCA RATON, Fla., J(GLOBE NEWSWIRE) - Saxena White P.A. Get instant alerts when news breaks on your stocks. ![]()
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