UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the month of May 2023
Commission File Number: 001-39461
NANO-X IMAGING LTD
Communications Center
Neve Ilan, Israel 9085000
(Address of principal executive office)
Indicate by check mark whether the registrant files or will file annualreports
under cover of Form 20-F or Form 40-F.
Form 20-F Form 40-F
Indicate by check mark if the registrant is submittingthe Form 6-K in paper as
permitted by Regulation S-T Rule 101(b)(1):
Note: Regulation S-T Rule 101(b)(1) onlypermits the submission in paper of a
Form 6-K if submitted solely to provide an attached annual report to security
holders.
Indicate by check mark if the registrant is submittingthe Form 6-K in paper as
permitted by Regulation S-T Rule 101(b)(7):
Note: Regulation S-T Rule 101(b)(7) only permitsthe submission in paper of a
Form 6-K if submitted to furnish a report or other document that the
registrant foreign private issuer mustfurnish and make public under the laws
of the jurisdiction in which the registrant is incorporated, domiciled or
legally organized (theregistrant's "home country"), or under the rules of the
home country exchange on which the registrant's securitiesare traded, as long
as the report or other document is not a press release, is not required to be
and has not been distributed to theregistrant's security holders, and, if
discussing a material event, has already been the subject of a Form 6-K
submission or otherCommission filing on EDGAR.
On May 14, 2023, NANO-X IMAGING LTD (the "Company")issued a press release, a
copy of which is attached hereto as Exhibit 99.1 and incorporated herein by
reference.
The information contained in this report is herebyincorporated by reference
into the Registration Statement on
Form S-8
, File No. 333-248322.
1
EXHIBIT INDEX
Exhibit No. Exhibit
99.1 Press release, dated May 1, 2023
2
SIGNATURES
Pursuant to the requirements of the SecuritiesExchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned, thereunto duly authorized.
NANO-X IMAGING LTD
By: /s/ Ran Daniel
Name: Ran Daniel
Title: Chief Financial Officer
Date: May 1, 2023
3
Exhibit 99.1
Nanox.ARCImaging System Receives FDA Clearance,
Pioneeringa New Era in Medical Imaging
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Nanox.ARC presents high powered digital X-ray tubes for 3D tomosynthesis imaging
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Nanox.ARC could help expand the availability of medical imaging
NEVE ILAN, Israel, May 1, 2023 (GLOBENEWSWIRE) - NANO-X IMAGING LTD ("Nanox"
or the "Company," Nasdaq: NNOX), an innovative medical imagingtechnology
company, today announced that it has received a 510(k) clearance from the U.S.
Food and Drug Administration (FDA) to marketthe multi-source Nanox.ARC,
including the Nanox.CLOUD, its accompanying cloud-based infrastructure.
Nanox.ARC is a stationary X-ray systemintended to produce tomographic images
of the human musculoskeletal system adjunctive to conventional radiography on
adult patients.Representing a major advancement in X-ray technology, Nanox.ARC
is a multi-source digital 3D tomosynthesis system that utilizes novel,cold
cathode X-ray tubes, which the Company intends to offer using an innovative
pay-per-scan business model.
The FDA clearedNanox.ARC for use in professional healthcare facilities or
radiological environments, such as hospitals, clinics,imaging
centers, and other medical practices by trained radiographers,
radiologists, and physicians, and has thepotential to increase
availability to medical imaging around the world, once approved by local
regulatory authorities and deployed atscale.
The Company received510(k) clearance to market its single-source X-ray device,
known as the Nanox Cart X-Ray System, in April 2021. The multi-source
Nanox.ARChas the ability to reconstruct a series of 2D projection images into
a stack of tomograms (or slices) of the imaged object, forming a3D
visualization. This visualization reduces the effect of overlying structures
and provides in-depth information on structures of interest.
"Today'smilestone is a significant achievement as part of our commitment to
make state-of-the-art medical imaging technology available for usein a wide
array of professional healthcare facilities and other medical practices," said
Erez Meltzer, Chief Executive Officerof Nanox. "Our vision is that Nanox's
innovative technology and approach not only have the potential to increase
access to medicalimaging, but also to shift healthcare from reactive to
proactive-enabling early detection and prevention of diseases."
Following this clearance,Nanox will continue to work with the FDA to pursue
additional regulatory clearances and intends to expand clinical indications.
The U.S.regulatory clearance also paves the way for Nanox.ARC to be approved
in other countries that are FDA-clearance-based markets. Other applicationswill
be available in other markets per local regulatory approvals.
Medical imagingsystems are an important early detection tool that are key to
initiating early treatment, improving health outcomes, and ultimately
savinglives. Approximately two-thirds of the world's population does not have
access to medical imaging systems, according to the WorldHealth Organization
(WHO),
1
while many people with access face substantial wait times for scanning,
potentially delayingdiagnoses. By introducing an innovative pay-per-scan
business model, Nanox offers an opportunity to help expand these resources to
morehealthcare settings.
While access tomedical imaging is relatively high in the U.S. compared to many
other countries, medical imaging can still be limited in certain areas,particula
rly in rural or low-income areas where facilities and equipment may be scarce.
For example, compared with patients at urbanhospitals, emergency department
patients in rural hospitals are 7% less likely to receive advanced imaging,
while patients at criticalaccess hospitals are 18% less likely to have
advanced imaging.
2
"The FDA clearance of Nanox.ARC representsan important breakthrough and
represents an opportunity to increase the availability and accessibility of
medical imaging in the UnitedStates and worldwide," said Geoffrey Rubin, MD,
MBA, Professor and Chairman of the Department of Medical Imaging at the
Universityof Arizona and a member of Nanox's Advisory Board. "Medical imaging
is essential for detecting, diagnosing, and managing disease,guiding treatment
decisions for improved health outcomes. Nanox.ARC has the potential to be a
cost-effective and scalable imaging solutionin healthcare settings that would
otherwise be unable to deploy traditional medical imaging equipment."
***
1 Pan American Health Organization and World Health Organization ("WHO"), 2012
2 Hanna TN, Friedberg E, Dequesada IM, Chaves L, Pyatt R, Duszak R , Jr, Hughes DR.
Disparities in the Use of Emergency Department Advanced Imaging in Medicare Beneficiaries.
Am J Roentgenol
. 2021; 216(2): 519-5215
EDITOR'S NOTE:
Photographs and video of Nanox.ARC are available upon request. Please contact
NanoxPR@icrinc.com.
AboutNanox
We, NANO-X IMAGINGLTD or Nanox (Nasdaq: NNOX), are focused on applying our
proprietary medical imaging technology and solutions to make diagnostic
medicinemore accessible and affordable across the globe.
Nanox's visionis to increase access, reduce costs and enhance the efficiency
of routine medical imaging technology and processes, in order to improveearly
detection and treatment, which Nanox believes is key to helping people achieve
better health outcomes, and, ultimately, to savelives.
The Nanox ecosystemincludes Nanox.ARC - a multi-source Digital Tomosynthesis
system that is cost-effective, and user-friendly; an AI-based suite of
algorithmsthat augment the readings of routine CT imaging to highlight early
signs often related to chronic disease, (Nanox.AI); a cloud-basedinfrastructure
(Nanox.CLOUD); and a proprietary decentralized marketplace, through Nanox's
subsidiary, USARAD Holdings Inc., thatprovides remote access to radiology and
cardiology experts; and a comprehensive teleradiology services platform
(Nanox.MARKETPLACE).
Together, Nanox'sproducts and services create a worldwide, innovative, and
comprehensive solution that connects medical imaging solutions, from scan
todiagnosis. For more information, please visit www.nanox.vision.
Forward-Looking Statements
This press release maycontain forward-looking statements that are subject to
risks and uncertainties. All statements that are not historical facts
containedin this press release are forward-looking statements. Such statements
include, but are not limited to, any statements relating to theinitiation,
timing, progress and results of the Company's research and development,
manufacturing, and commercialization activitieswith respect to its X-ray
source technology and the Nanox.ARC, the ability to realize the expected
benefits of its recent acquisitionsand the projected business prospects of the
Company and the acquired companies. In some cases, you can identify
forward-looking statementsby 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-lookingstatements are based on
information the Company has when those statements are made or management's
good faith belief as of thattime with respect to future events and are subject
to risks and uncertainties that could cause actual performance or results to
differmaterially from those expressed in or suggested by the forward-looking
statements. Factors that could cause actual results to differmaterially from
those currently anticipated include: risks related to (i) Nanox's ability to
continue to develop of the Nanox imagingsystem; (ii) Nanox's ability to
successfully demonstrate the feasibility of its technology for commercial
applications; (iii) Nanox'sexpectations regarding the necessity of, timing of
filing for, and receipt and maintenance of, regulatory clearances or approvals
regardingits technology, the Nanox.ARC and Nanox.CLOUD from regulatory
agencies worldwide and its ongoing compliance with applicable quality
standardsand regulatory requirements; (iv) Nanox's ability to realize the
anticipated benefits of acquisitions, which may be affected by,among other
things, competition, brand recognition, the ability of the acquired companies
to grow and manage growth profitably and retaintheir key employees; (v)
Nanox's ability to enter into and maintain commercially reasonable
arrangements with third-party manufacturersand suppliers to manufacture the
Nanox.ARC; (vi) the market acceptance of the Nanox imaging system and the
proposed pay-per-scan businessmodel; (vii) Nanox's expectations regarding
collaborations with third-parties and their potential benefits; and (viii)
Nanox'sability to conduct business globally; (ix) changes in global,
political, economic, business, competitive, market and regulatory forces;and
(x) risks related to business interruptions resulting from the COVID-19
pandemic or similar public health crises, among other things.
For a discussion of otherrisks and uncertainties, and other important factors,
any of which could cause Nanox's actual results to differ from those
containedin the Forward-Looking Statements, see the section titled "Risk
Factors" in Nanox's Annual Report on Form 20-F forthe year ended December 31,
2022 , and subsequent filings with the U.S. Securities and Exchange
Commission. The reader should not placeundue reliance on any forward-looking
statements included in this press release.
Except as requiredby law, Nanox undertakes no obligation to update publicly
any forward-looking statements after the date of this press release to
conformthese statements to actual results or to changes in the Company's
expectations.
Contacts
Media Contact:
Rachael Roselli
ICR Westwicke
NanoxPR@icrinc.com
Investor Contact:
Mike Cavanaugh
ICR Westwicke
mike.cavanaugh@westwicke.com