Nano-X Imaging Ltd.
The law firm of Kirby McInerney LLP announces that a class action lawsuit has been filed in the United States District Court for the Eastern District of New York on behalf of those who acquired Nano-X Imaging Ltd. (“Nano-X” or the “Company”) (NASDAQ: NNOX) securities from June 17, 2021 through August 18, 2021, inclusive (the “Class Period”). Investors have until December 6, 2021 to apply to the Court to be appointed as lead plaintiff in the lawsuit.
Nano-X is a development-stage company that develops, produces, and commercializes digital X-ray source technology for the medical imaging industry worldwide.
On June 17, 2021, Nano-X intrigued investors when it announced that it had submitted a 510(k) submission to the U.S. Food and Drug Administration (“FDA”) to demonstrate the Nanox.ARC is marketed as safe and effective and substantially equivalent to a legally marketed device.
On August 19, 2021, Nano-X reported that the Company has “received a request for additional information from the [FDA] concerning the Company’s last 510(k) submission of its multi-source device, Nanox.ARC. The submission file is placed on hold pending a complete response to the FDA’s list of deficiencies. The Company’s response is due within 180 days from the date of the request for additional information.” On this news, the Company’s share price declined by $2.25 per share, or approximately 9.5%, from $23.68 per share to close at $21.43 per share on August 19, 2021.
The lawsuit alleges throughout the Class Period, Defendants made materially false and misleading statements regarding the Company’s business, operations, and compliance policies. Specifically, Defendants made false and/or misleading statements and/or 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) as a result, the Company’s public statements were materially false and misleading at all relevant times.