SAN FRANCISCO, CA/ ACCESSWIRE / October 28, 2021 / Hagens Berman urges Nano-X Imaging Ltd. (NASDAQ:NNOX) investors with significant losses to submit your losses now.
Nano-X Imaging Ltd. (NNOX) Securities Fraud Class Action:
Nano-X, a digital X-ray company, is developing the "Nanox.ARC," an imaging system that uses a purportedly novel X-ray source.
On June 17, 2021, Nano-X intrigued investors when it announced that it had submitted a 510(k) submission to the FDA to demonstrate the Nanox.ARC is marketed as safe and effective and substantially equivalent to a legally marketed device.
The litigation alleges that Defendants misled investors concerning the 510(k) submission for Nanox.ARC. Specifically, while touting Nanox.ARC's regulatory and commercial prospects, Defendants concealed: (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; and (iii) as a result, Nano- X had overstated Nanox.ARC's regulatory and commercial prospects.
The truth emerged on Aug. 19, 2021, when Nano-X reported that the Company received a request for additional information from the FDA concerning Nano-X's 510(k) application for the Nanox.ARC, and that the submission file is placed on hold pending Nano-X's complete response to the FDA's list of deficiencies within 180 days.
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 Aug. 19, 2021.
"We're focused on investors' losses and proving Nano-X mispresented Nanox.ARC's regulatory and commercial prospects," said Reed Kathrein, the Hagens Berman partner leading the investigation.
If you invested in Nano-X Imaging and have significant losses, or have knowledge that may assist the firm's investigation, click here to discuss your legal rights with Hagens Berman.
Whistleblowers: Persons with non-public information regarding Nano-X Imaging should consider their options to help in the investigation or take advantage of the SEC Whistleblower program. Under the new program, whistleblowers who provide original information may receive rewards totaling up to 30 percent of any successful recovery made by the SEC. For more information, call Reed Kathrein at 844-916-0895 or email [email protected].
About Hagens Berman
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Reed Kathrein, 844-916-0895
SOURCE: Hagens Berman Sobol Shapiro LLP