A securities class action has been filed against Nano-X Imaging Ltd. (NNOX) on behalf of a class consisting of all persons and entities other than Defendants that purchased or otherwise acquired Nano-X securities between June 17, 2021 through August 18, 2021. This case has been filed in the USDC – E.D.N.Y.
Nano-X is a development-stage company that develops, produces, and commercializes digital X-ray source technology for the medical imaging industry worldwide. The Company is developing, among other technologies, the “Nanox.ARC”, which is an imaging system that uses a purportedly novel X-ray source, also developed by the Company.
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 SEC filings.
The complaint alleges that, 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.
On August 19, 2021, Nano-X reported that the Company “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 $2.25 per share, or 9.5%, to close at $21.43 per share on August 19, 2021.