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.
We also encourage you to contact Lesley F. Portnoy of The Portnoy Law Firm, at 310.692.8883, to discuss your rights free of charge. You can also reach us through the firm’s website at www.portnoylaw.com, or by email at info@portnoylaw.com.
If you choose to take no action, you can remain an absent class member.
Joining the case through the Portnoy Law website enables investors to learn about their legal claims and take an active role in recovering their losses.
The Portnoy Law Firm represents investors around the world and specializes in securities class action lawsuits and shareholder rights litigation.
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
The lawsuit centers on whether Outset Medical properly disclosed information about its business prospects and operations, particularly related to its Tablo Hemodialysis System (“Tablo products”). On July 29, 2022, the company received FDA Section 510(k) clearance for Tablo products, which were approved for use in patients with acute or chronic renal failure, both in clinical settings and at home.
The complaint accuses Outset Medical of making false or misleading statements and failing to reveal that: (1) the Tablo products were marketed for continuous renal replacement therapy, an indication not approved by the FDA; (2) this marketing strategy likely meant the company would need to submit a new 510(k) application to the FDA; (3) there was a significant risk that sales of Tablo products would be halted until additional FDA approval was obtained; (4) the company lacked the necessary sales infrastructure to support increasing Tablo sales; and (5) these issues would negatively impact revenue growth.
Investors began to uncover the truth on July 7, 2023, when Outset Medical disclosed it had received an FDA warning letter stating the company was promoting the TabloCart, a product not authorized under the existing 510(k) clearance.
On August 2, 2023, the company announced it was suspending shipments of the TabloCart while waiting for additional FDA clearance through a new 510(k) application.
Further, investors learned that the FDA warning and the halt in TabloCart sales would harm Outset Medical’s financial performance. On October 12, 2023, the company reported disappointing Q3 2023 financial results and provided guidance indicating slowed growth due to the FDA warning.
Subsequently, on August 7, 2024, the company released disappointing Q2 2024 financial results and revised guidance, highlighting the need for “clear steps to improve execution,” including restructuring the sales team and process, and admitting it would not meet earlier sales forecasts for TabloCart.
