Full Press Release Details
Nanox Announces FDA Clearance of 510(k) for Single
Source Nanox.ARC Digital X-Ray
NEVE ILAN, Israel - April 2, 2021 -- NANO-X
IMAGING LTD (NASDAQ: NNOX) ("Nanox" or the "Company"), an innovative medical imaging technology
company, announced today that its single-source Nanox.ARC digital x-ray technology has received 510(k) clearance from the US Food and
Drug Administration (the "FDA").
"Obtaining 510(k) clearance from the FDA
for our single-source Nanox.ARC digital x-ray is a significant step forward along our US regulatory pathway," stated Ran Poliakine,
Chairman and Chief Executive Officer of Nanox. "We remain on track to commence system shipments in the fourth quarter of 2021 and
the first quarter of 2022 with the goal of finalizing deployment of the initial 15,000 Nanox.ARC systems by the end of 2024."
"We believe we are well positioned to
achieve our goal of democratizing medical imaging and expanding the market to the roughly two-thirds of the world's population who
currently have limited or no meaningful access to imaging or the preventative screening that it offers," Mr. Poliakine concluded.
The Company remains on track and expects to
submit a 510(k) application to the FDA for its multi-source Nanox.ARC and the Nanox.CLOUD in 2021. If cleared, the multi-source Nanox.ARC
will be the Company's commercial imaging system that it expects to deploy broadly across the globe.
Nanox, founded by the serial entrepreneur Ran
Poliakine, is an Israeli corporation that is developing a commercial-grade digital X-ray source designed to be used in real-world medical
imaging applications. Nanox believes that its novel technology could significantly reduce the costs of medical imaging systems and plans
to seek collaborations with world-leading healthcare organizations and companies to provide affordable, early detection imaging service
for all. For more information, please visit www.nanox.vision.
Forward-Looking Statements:
This press release may contain forward-looking
statements that are subject to risks and uncertainties. All statements that are not historical facts contained in this press release are
forward-looking statements. Such statements include, but are not limited to, any statements relating to the initiation, timing, progress
and results of Nanox's research and development, manufacturing and commercialization activities with respect to its X-ray source technology
and the Nanox.Arc. In some cases, you can identify forward-looking statements by terminology such as "can," "might,"
"believe," "may," "estimate," "continue," "anticipate," "intend,"
"should," "plan," "should," "could," "expect," "predict," "potential,"
or the negative of these terms or other similar expressions. Forward-looking statements are based on information Nanox has when those
statements are made or management's good faith belief as of that time with respect to future events, and are subject to risks and uncertainties
that could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking statements.
Factors that could cause actual results to differ materially from those currently anticipated include: risks related to business interruptions
resulting from the COVID-19 pandemic or similar public health crises could cause a disruption of the development, deployment or regulatory
clearance of the Nanox System and adversely impact our business; Nanox's ability to successfully demonstrate the feasibility of its technology
for commercial applications; Nanox's expectations regarding the necessity of, timing of filing for, and receipt and maintenance of, regulatory
clearances or approvals regarding its X-ray source technology and the Nanox.Arc from regulatory agencies worldwide and its ongoing compliance
with applicable quality standards and regulatory requirements; Nanox's ability to enter into and maintain commercially reasonable arrangements
with third-party manufacturers and suppliers to manufacture the Nanox.Arc; the market acceptance of the Nanox.Arc and the proposed pay-per-scan
business model; Nanox's expectations regarding collaborations with third-parties and their potential benefits; and Nanox's ability to
conduct business globally, among others. Except as required by law, Nanox undertakes no obligation to update publicly any forward-looking
statements after the date of this press release to conform these statements to actual results or to changes in Nanox's expectations.