
Kewaunee Scientific Corporation (KEQU)
Whether directors and officers of Kewaunee Scientific Corporation (KEQU) breached their fiduciary duties to the company and its shareholders.
Investigation
05/04/2022
Initial Lawsuit
07/08/2022
Lawsuit Progression
09/06/2022
Were Outset Medical’s statements about Tablo updates and improvements misleading? Were the changes so drastic that the FDA would require an additional 510(k) application and require Outset to hold shipments?
Was so company well aware that making changes would trigger FDA review?
This post is open for investors to gather facts, and findings and track their exposure to related lawsuits. We invite investors and shareholders to contribute to this investigation for their own benefit, add events to the factual timeline below and vote on events’ pertinence.
A lawsuit was subsequently filed. We will update this post as it unfolds.
06/13/2022
Outset Medical announces 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. As a result of the shipment hold, the company suspended its prior guidance and announced expected Q2 2022 revenue of $25 million. “The company anticipates an update on the status of the regulatory review process in the third quarter and to provide an update to its 2022 revenue and other financial goals during its next quarterly update in early August.”
“Outset has not identified any safety issues with Tablo. The company will continue to market and ship Tablo for use by healthcare professionals in chronic and acute care settings. Devices that are already distributed to home users have not been removed and current users can continue to work with their healthcare providers on appropriate treatment . . .“
Stock Impact
Close | Previous close | Price variation | Percentage variation |
---|---|---|---|
$13.46 | $20.41 | $-6.95 | -34.05% |
An Outset Medical, Inc. (OM) investor filed a federal securities class action lawsuit on behalf of all persons or entities who purchased Outset Medical common stock between September 15, 2020, and June 13, 2022, inclusive.
According to the complaint, defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the company’s business, operations, and prospects. Specifically, defendants allegedly failed to disclose to investors 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 lead plaintiff deadline has passed, we will update this page as the lawsuit progresses.
Last event retrieved on 09/26/2022.
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