by John R. Fischer
, Senior Reporter | August 24, 2021
The FDA is holding Nanox's 510(k) premarket application for its multi-source, digital tomosynthesis solution
Stock in Nanox fell Thursday following a hold placed by the FDA on the premarket application for the company’s multisource, digital tomosynthesis imaging system.
Shares lost nearly 10% of their value Thursday, following five days of losses, reports Seeking Alpha
. The hold will remain until Nanox fixes a number of deficiencies found in its Nanox.Arc 3-D digital tomosynthesis system, according to a filing with the Securities and Exchange Commission.
In response, the company says it will respond by the due date, which is set at 180 days after the federal government’s request for more information was made. “The company expects to continue to optimize and develop further features of Nanox.ARC and is considering submitting an additional 510(k) application for the next version of multi-source Nanox.ARC during the fourth quarter of 2021, which will benefit from the FDA’s feedback on the first version of the multi-source Nanox.ARC,” officials said in the Aug. 19 SEC filing.
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Nanox.Arc 3-D digital tomosynthesis system is designed with multiple alternatively-switched X-ray tubes arranged around the patient to scan human body parts and is intended to increase affordable access to imaging for healthcare populations worldwide. The solution is based on proprietary silicon MEMs semiconductor technology, which allows for the generation of electrons without using heat, with the system still performing at the same level as legacy X-ray systems.
The additional application may include the addition of higher-power tubes for a wider range of indications that could raise the chances of its commercial success, according to Cantor Fitzgerald analyst Steven Halper. He also says that the filing of the next 510(k) “is probably a positive,” if it is done on a timely basis, according to Seeking Alpha
its premarket application for the solution back in June. The announcement of the application sent company stocks soaring over 15% on NASDAQ, with shares hovering around $31.
This was a far cry from last September when the company’s stock plummeted
from $66.67 to $28.60 due to a class action lawsuit filed by investors. The suit was the result of a report published by online stock commentator, Citron Research, which accused Nanox of failing to produce any evidence comparing Nanox.Arc to conventional CT scanners, criticized its R&D spending, and claimed it fabricated distribution agreements with fake customers.