A lawsuit was filed on behalf of investors in Outset Medical, Inc. (NASDAQ: OM) shares over alleged securities laws violations.
San Diego, CA -- (SBWIRE) -- 08/16/2022 -- An investor, who purchased shares of Outset Medical, Inc. (NASDAQ: OM), filed a lawsuit over alleged Securities Laws violations by Outset Medical, Inc..
Investors who purchased shares of Outset Medical, Inc. (NASDAQ: OM) have certain options and for certain investors are short and strict deadlines running. Deadline: September 6, 2022. NASDAQ: OM investors should contact the Shareholders Foundation at firstname.lastname@example.org or call +1(858) 779 - 1554.
San Jose, CA based Outset Medical, Inc., a medical technology company, develops a hemodialysis system for dialysis. On June 13, 2022, Outset Medical, Inc. announced that "it has implemented a shipment hold on the distribution of its Tablo Hemodialysis System for home use pending the Food and Drug Administration's (FDA) review and clearance of a 510(k) the company submitted for changes made since the device's original March 2020 clearance."
Shares of Outset Medical, Inc. (NASDAQ: OM) declined from $40.51 per share on May 4, 2022, to as low as $13.25 per share on June 14, 2022.
The plaintiff claims that between September 15, 2020 and June 13, 2022, the Defendants misled investors and/or failed to disclose that Defendants had "continuously made improvements and updates to Tablo over time since its original clearance" that required an additional 510(k) application, that as a result, the Company could not conduct a human factors study on a cleared device in accordance with FDA protocols, that 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 that 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.
Those who purchased shares of Outset Medical, Inc. (NASDAQ: OM) have certain options and should contact the Shareholders Foundation.
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