According to the lawsuit, during the Class Period, defendants made false and/or misleading statements and/or failed to disclose that:
- the TabloCart would require prior 510(k) clearance from the FDA for marketing authorization;
- the Company had not obtained the required FDA clearance to market and sell the TabloCart;
- as such, Outset would be forced to halt shipment of the TabloCart;
- Outset had promoted continuous renal replacement therapy (or CRRT) as a modality within the FDA-approved indications for the Tablo, which was not the case;
- Outset lacked the sales team and process to execute on the ramp of Tablo sales;
- the Company’s internal controls were inadequate and resulted in the improper marketing of Tablo and TabloCart and that the Company’s SOX certifications were false and misleading when made;
- the Company’s reports and financial statements did not fairly present in all material respects the financial condition, including the reliance on improper marketing, that the revenue and growth reported therein was the result of undisclosed, illicit and unsustainable improper marketing; and
- 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.
No Class Has Been Certified. Until a class is certified, you are not represented by counsel unless you retain one. You may select counsel of your choice. You may also remain an absent class member and do nothing at this point. An investor’s ability to share in any potential future recovery is not dependent upon serving as lead plaintiff.
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