Bragar Eagel & Squire, P.C., a nationally recognized stockholder rights law firm, announces that a class action lawsuit has been filed against Nano-X Imaging Ltd. (“Nano-X” or the “Company”) (NASDAQ: NNOX) in the United States District Court for the Eastern District of New York on behalf of all persons and entities who purchased or otherwise acquired Nano-X securities between June 17, 2021 and August 18, 2021, both dates inclusive (the “Class Period”). Investors have until December 6, 2021 to apply to the Court to be appointed as lead plaintiff in the lawsuit.
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On June 17, 2021, Nano-X submitted a 510(k) submission to the U.S. Food and Drug Administration (the “FDA”) for its multi-source version of the Nanox.ARC. A 510(k) is a type of premarket submission made to the FDA to demonstrate that a device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device. Following this submission, defendants touted the Nanox.ARC’s regulatory and commercial prospects in various public statements and U.S. Securities and Exchange Commission filings.
The Nano-X class action lawsuit alleges that, throughout the Class Period, defendants made false and misleading statements and failed to disclose that: (i) Nano-X’s 510(k) application for the Nanox.ARC was deficient; (ii) accordingly, it was unlikely that the FDA would approve the 510(k) application for the Nanox.ARC in its current form; (iii) as a result, Nano-X had overstated the Nanox.ARC’s regulatory and commercial prospects; and (iv) consequently, Nano-X’s public statements were materially false and misleading at all relevant times.
On August 19, 2021, Nano-X reported that Nano-X “received a request for additional information from the [FDA] concerning the Company’s last 510(k) submission of its multi-source device, Nanox.ARC,” and that “[t]he submission file is placed on hold pending a complete response to the FDA’s list of deficiencies,” with “[t]he Company’s response . . . due within 180 days from the date of the request for additional information.” On this news, Nano-X’s ordinary share price fell nearly 10%, damaging investors.
If you purchased or otherwise acquired Nano-X shares and suffered a loss, are a long-term stockholder, have information, would like to learn more about these claims, or have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Brandon Walker, Melissa Fortunato, or Marion Passmore by email at firstname.lastname@example.org, telephone at (212) 355-4648, or by filling out this contact form. There is no cost or obligation to you.
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