Outset Medical, Inc.
Investors that purchased the Company’s securities and have suffered a loss, please fill in transaction information below, or email to info@portnoylaw.com.
There is no cost or obligation associated with submitting your information. If you are a shareholder who suffered a loss, please submit your contact information and purchase information to participate in the putative class action.
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CONTACT:
Portnoy Law Firm
Lesley F. Portnoy, Esq.,
www.portnoylaw.com
Office: 310.692.8883
1800 Century Park East, Suite 600
Los Angeles, CA 90067
info@portnoylaw.com
Outset, headquartered in San Jose, California, is a medical technology company whose chief product, the Tablo Hemodialysis System (“Tablo”), is used for the treatment of acute and chronic kidney failure.
The action alleges that, throughout the Class Period, Outset misled investors and/or failed to disclose that: (1) the Company had “continuously made improvements and updates to Tablo over time since its original clearance,” which required further studies and potentially new applications to the U.S. Food and Drug Administration (“FDA”); (2) in the absence of such studies and FDA approval, the Company could not conduct a human factors study on the Tablo pursuant to FDA protocols; and (3) Outset’s inability to conduct the human factors study exposed the Company to the risk of FDA actions, including a shipping hold and marketing suspension, rendering Outset incapable of selling Tablo for home use.
On May 4, 2022, after markets closed, Outset announced disappointing financial results for the first quarter of 2022, which analysts attributed in part to Tablo’s untested performance in the home setting. On this news, the price of Outset common stock fell $16.88, or 2.26% over the next three trading days, from a closing price of $39.94 per share on Wednesday, May 4, 2022, to close at $23.06 per share on Monday, May 9, 2022, on elevated trading volume.
On June 13, 2022, after markets closed, Outset announced that the FDA compelled the Company to suspend all shipments of Tablo for home use until Outset obtained the requisite regulatory clearance. On this news, the price of Outset stock fell $6.95, or 34.05%, from a closing price of $20.41 per share on June 13, 2022, to close at $13.46 per share on June 14, 2022, on extremely heavy trading volume.
