If you are a shareholder who purchased Nano-X securities during the Class Period, you have until December 6, 2021 to ask the Court to appoint you as Lead Plaintiff for the class. A copy of the Complaint can be obtained at www.pomerantzlaw.com. To discuss this action, contact Robert S. Willoughby at firstname.lastname@example.org or 888.476.6529 (or 888.4-POMLAW), toll-free, Ext. 7980. Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased.
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.
The Pomerantz Firm, with offices in New York, Chicago, Los Angeles, and Paris, is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, the Pomerantz Firm pioneered the field of securities class actions. Today, more than 80 years later, the Pomerantz Firm continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. See www.pomerantzlaw.com
Robert S. Willoughby
888-476-6529 ext. 7980