Lawsuit Notice: Investors who lost money with shares of Outset Medical, Inc. (NASDAQ: OM) should contact the Shareholders Foundation

An investor, who purchased shares of Outset Medical, Inc. (NASDAQ: OM), filed a lawsuit over alleged violations of Federal Securities Laws by Outset Medical, Inc. in connection with certain allegedly false and misleading statements.

Investors who purchased shares of Outset Medical, Inc. (NASDAQ: OM) have certain options and for certain investors are short and strict deadlines running. Deadline: October 28, 2024. NASDAQ: OM investors should contact the Shareholders Foundation at mail@shareholdersfoundation.com or call +1(858) 779 - 1554.

San Jose, CA based Outset Medical, Inc., a medical technology company, engages in the development of a hemodialysis system for hemodialysis in the United States.

On July 7, 2023, Outset Medical, Inc. disclosed that it had received a Warning Letter from the FDA which "asserted that certain materials . . . promote continuous renal replacement therapy (CRRT), a modality outside of the current indications for the Tablo Hemodialysis System" and "assert[ed] that the TabloCart with Prefiltration . . . requires prior 510(k) clearance for marketing authorization," and that the Company would "work collaboratively with the FDA to resolve this observation, including potentially submitting a 510(k) on TabloCart."

On August 2, 2023, Outset Medical, Inc. announced a "Shipment Pause of TabloCart with Prefiltration Pending 510(k) Clearance."

On October 12, 2023, Outset Medical, Inc. revealed that revenue growth had been significantly impacted by the FDA's warning letter. Specifically, the Company issued a press release announcing preliminary third quarter 2023 financial results, as well as updated financial guidance for 2023 revenue, which reflected that "[g]rowth in the quarter was dampened by a larger-than-expected impact in the field from the recent FDA warning letter."

On August 7, 2024, Outset Medical, Inc. reported its second-quarter financial results, revealing a notable decrease in revenue and a downward adjustment in its full-year guidance. The company's revenue for Q2 2024 fell to $27.4 million, a significant drop from $36.0 million in the same period the previous year. Product revenue also diminished, reaching only $19.2 million. Additionally, new console placements did not meet expectations, further impacting overall performance. As a result, Outset Medical, Inc. revised its full-year 2024 revenue guidance to $110 million, a substantial reduction from the earlier projected range of $145 to $153 million.

Shares of Outset Medical, Inc. (NASDAQ: OM) declined from $4.84 per share on July 16, 2024, to low as $.05750 per share on August 21, 2024.

The plaintiff claims that between August 1, 2022 and August 7, 2024, the Defendants failed to disclose to investors, that the Tablo products were marketed for continuous renal replacement therapy, which is not one of the indications approved by the FDA, that, as a result, Outset Medical was reasonably likely to submit an additional 510(k) application for the Tablo products, that there was a substantial risk that the Company would cease sales of the Tablo products pending FDA approval of additional indications, that Outset Medical lacked the sales team and process to execute on the ramp of Tablo sales, that, as a result of the foregoing, the Company's revenue growth would be adversely impacted, and that, as a result of the foregoing, Defendants' positive statements about the Company's business, operations, and prospects were materially misleading and/or lacked a reasonable basis.

Those who purchased shares of Outset Medical, Inc. (NASDAQ: OM) have certain options and should contact the Shareholders Foundation.

Contact:
Michael Daniels
Shareholders Foundation, Inc.
3111 Camino Del Rio North
Suite 423
San Diego, CA 92108
Tel: +1-(858)-779-1554
E-Mail: mail@shareholdersfoundation.com

About Shareholders Foundation, Inc.
The Shareholders Foundation, Inc. is a professional portfolio monitoring and settlement claim filing service, and an investor advocacy group, which does research related to shareholder issues and informs investors of securities lawsuits, settlements, judgments, and other legal related news to the stock/financial market. Shareholders Foundation, Inc. is in contact with a large number of shareholders and offers help, support, and assistance for every shareholder. The Shareholders Foundation, Inc. is not a law firm. Referenced cases, investigations, and/or settlements are not filed/initiated/reached and/or are not related to Shareholders Foundation. The information is provided as a public service. It is not intended as legal advice and should not be relied upon.

This release was published on openPR.