SAN FRANCISCO, Aug. 09, 2022 (GLOBE NEWSWIRE) -- Hagens Berman urges Outset Medical, Inc. (NASDAQ: OM) investors who have suffered over $300,000 losses to submit your losses now.
Class Period: Sept. 15, 2020 – June 13, 2022
Lead Plaintiff Deadline: Sept. 6, 2022
Visit: www.hbsslaw.com/investor-fraud/OM
Contact An Attorney Now: OM@hbsslaw.com
844-916-0895
Outset Medical, Inc. (NASDAQ: OM) Securities Fraud Class Action:
The complaint challenges Outset’s claims concerning its flagship product, Tablo, including that it can “serve as a dialysis clinic on wheels” and that it had been cleared by the FDA for use in hospitals, clinics, and home settings under Section 510(k) of the Federal Food Drug and Cosmetics Act. The complaint also focuses on Outset’s statements that, when conducting additional regulatory studies pertaining to Tablo, it adhered to the FDA-approved protocol (including submission of data obtained through real-world human testing).
Specifically, Defendants misrepresented or failed to disclose that Outset: (1) continuously improved and updated Tablo, necessitating an additional 510(k) application; (2) did not conduct a real-world human factors study for Tablo use at home in accordance with FDA protocol; and therefore, (3) risked a Tablo-for-home-use shipment hold and marketing suspension.
The truth emerged on June 13, 2022, when Outset revealed that in late May it implemented a shipment hold on Tablo for home use pending the FDA’s review and clearance of its 510(k) application, its 510(k) submission did not include data obtained through real-world human testing consistent with the FDA-approved protocol and, as a result, it suspended 2022 and long-term financial guidance.
This news drove the price of Outset Medical shares sharply lower.
“We’re focused on recovering investors’ losses and proving Defendants misled investors about Outset’s FDA clearance for Tablo and its adherence to FDA-approved protocols,” said Reed Kathrein, the Hagens Berman partner leading the investigation.
If you invested in Outset and have significant losses, or have knowledge that may assist the firm’s investigation, click here to discuss your legal rights with Hagens Berman.
Whistleblowers: Persons with non-public information regarding Outset should consider their options to help in the investigation or take advantage of the SEC Whistleblower program. Under the new program, whistleblowers who provide original information may receive rewards totaling up to 30 percent of any successful recovery made by the SEC. For more information, call Reed Kathrein at 844-916-0895 or email OM@hbsslaw.com.
About Hagens Berman
Hagens Berman is a global plaintiffs’ rights complex litigation law firm focusing on corporate accountability through class-action law. The firm is home to a robust securities litigation practice and represents investors as well as whistleblowers, workers, consumers and others in cases achieving real results for those harmed by corporate negligence and fraud. More about the firm and its successes can be found at hbsslaw.com. Follow the firm for updates and news at @ClassActionLaw.
Contact:
Reed Kathrein, 844-916-0895
