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 February 2024
Commission File Number: 001-39461
NANO-X IMAGING LTD
Ofer Tech Park
94 Shlomo Shmeltzer Road
Petach Tikva
Israel 4970602
(Address of principal executive office)
Indicate by check mark whether the registrantfiles or will file annual reports
under cover of Form 20-F or Form 40-F.
Form 20-F
Form 40-F
On February 13, 2024, NANO-X IMAGING LTD. (the"Company")
announced that
its deep-learning medical imaging analytics subsidiary,Nanox AI Ltd., received
510(k) clearance by the U.S. Food and Drug Administration (FDA) for its
artificial intelligence (AI) software,HealthFLD.
The contents of this Form 6-K, excludingExhibit 99.1 attached hereto, are
incorporated by reference into the Registration Statement on
FormF-3
, File No. 333-271688, and
FormS-8
, File No. 333-248322.
EXHIBIT INDEX
Exhibit No. Exhibit
99.1 Press release, dated February 13, 2024
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SIGNATURES
Pursuant to the requirementsof the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned, thereuntoduly authorized.
NANO-X IMAGING LTD
.
By: /s/ Ran Daniel
Name: Ran Daniel
Title: Chief Financial Officer
Date: February 13, 2024
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Exhibit 99.1
Nanox Receives FDA Clearance for HealthFLD,an Advanced AI-Based
Software Empowering Clinicians in Assessment of Fatty Liver
Nanox's HealthFLD is pioneering the useof a fully automated AI software for
liver
attenuation analysis from CT scans that has received FDA 510(k) clearance for
use in generalpopulation
Expands Nanox's offering in AI solutions,marking third product in Nanox AI's
suite of
population health solutions to become commercially available
PETACH TIKVA, Israel - (BUSINESS WIRE) - February 13, 2024 ("Nanox"or the
"Company," Nasdaq: NNOX), an innovative medical imaging technology company,
today announced that its deep-learning medicalimaging analytics subsidiary,
Nanox AI Ltd., received 510(k) clearance by the U.S. Food and Drug
Administration (FDA) for HealthFLD, anartificial intelligence (AI) software
that provides automated qualitative and quantitative analysis of liver
attenuation from routinecontrast and non-contrast chest and abdomen CT scans
in patients between the ages of 18 to 75. HealthFLD is intended to support
cliniciansin the detection of fatty liver, correlated with hepatic steatosis,
an early sign of metabolic dysfunction-associated steatotic liverdisease
(MASLD), formerly referred to as non-alcoholic fatty liver disease (NAFLD).
An estimated 24% of U.S. adults are living withMASLD or NAFLD
i
, a metabolic disease linked to obesity, cardiovascular disease and type 2
diabetes, all of which pose significantpublic health concerns. Adults with
MASLD are not only at risk of developing severe liver complications, such as
cirrhosis and metabolicdysfunction-associated steatohepatitis (MASH), but are
also at risk of cardiovascular disease, which is the leading cause of death
inpeople living with MASLD
ii
. MASLD is commonly asymptomatic until it progresses to advanced liver
fibrosis, and the currentgold standard for diagnosis is a liver biopsy, which
is invasive and costly. As such, early diagnosis of MASLD could benefit
patientsand the healthcare system.
While AI assessment of medical imaging offers areliable, non-invasive,
large-scale approach to support clinicians in the assessment of hepatic
steatosis (fatty liver), it has traditionallybeen difficult to assess liver
attenuation on contrast-enhanced scans - which make up a large proportion of
CT scans - limitingthe ability of clinicians to detect non-severe cases of
MASLD
iii
. HealthFLD was designed to help clinicians in the assessmentand analysis of
fatty liver in the general population from routine CT scans.
Amidst rising obesity rates, the prevalence ofliver-related disease is
growing, and the need for an approved treatment for MASH has yet to be met.
With several late-stage drug candidatesfor MASH in development and the
availability of GLP-1 drugs for the management of type 2 diabetes and other
metabolic diseases, identificationof liver steatosis is especially relevant.
"We are proud to offer HealthFLD as the thirdproduct of Nanox AI's suite of
cutting-edge, AI-powered population health solutions designed to confront
chronic diseases of greatpublic health concern head-on and potentially improve
health outcomes," said Erez Meltzer, Chief Executive Officer of Nanox.
"Furthermore,we believe that AI innovative solutions, and specifically
HealthFLD, may deliver substantial advantages to the biopharmaceutical
industryto streamline the identification of candidates for clinical trials of
much-needed therapies for liver diseases including MASH. This regulatorydecision
solidifies our leadership as a developer of
automatedAI software medical devices."
i Younossi ZM, Koenig AB, Abdelatif D, Fazel Y, Henry L, WymerM. Global epidemiology of
nonalcoholic fatty liver disease-meta-analytic assessment of prevalence, incidence, and outcomes.
Hepatology
.2016;64(1):73-84. doi:10.1002/hep.28431
ii Dulai PS, Singh S, Patel J, Soni M, Prokop LJ, Younossi Z, etal. Increased risk of mortality by fibrosis
stage in nonalcoholic fatty liver disease: systematic review and meta-analysis. Hepatology2017;65:1557-65.
iii Pickhardt PJ, Blake GM, Kimmel Y, et al. Detection of ModerateHepatic Steatosis on Portal
Venous Phase Contrast-Enhanced CT: Evaluation Using an Automated Artificial Intelligence Tool.
Amer JourRoentgen
2023;221(6): 748 - 758.
In a retrospective 2023 study of 2,917 patients,published in the
American Journal of Roentgenology (AJR),
the HealthFLD AI software demonstrated high performance in the detectionof at
least moderate hepatic steatosis in contrast-enhanced CT scans, with a
sensitivity of 77.8% and specificity of 93.2% at less than80 HU. Medical
imaging offers the only reliable noninvasive method for quantifying liver fat.
Integrating HealthFLD with widely used standardCT scans offers clinicians the
potential to opportunistically screen for liver steatosis and possible signs
of MASLD on a population level."In recent years, automated, deep learning
tools have offered an efficient, low-cost tool used to detect diseases in
earlier stages,"said Perry J. Pickhardt, MD, of the University of Wisconsin
School of Medicine & Public Health, and lead author of the AJR study
.
"We are now at a watershed moment when metabolic diseases are growing in
prevalence and more effective treatment options arebecoming available. It's
promising to have a liver solution available that may help evaluate early
signs of illness from routineimaging."
The HealthFLD clearance is the third product acrossthe Nanox AI suite of
population health solutions to receive FDA clearance. The FDA previously
cleared HealthCCSng, a solution that detectscoronary artery calcium (CAC) that
presents a risk for coronary artery disease, and HealthOST, a solution that
assesses vertebral compressionfractures and bone mineral density to support
clinicians in the evaluation and assessment of musculoskeletal disease of the
spine (suchas osteoporosis).
About Metabolic Dysfunction-Associated SteatoticLiver Disease (MASLD)
Metabolic dysfunction-associated steatotic liverdisease (MASLD), formerly
referred to as non-alcoholic fatty liver disease (NAFLD), refers to a group of
metabolic conditions linkedto obesity, cardiovascular disease and type 2
diabetes. An estimated 30% of the adult population globally has MASLD,
iv
a major risk factor for chronic liver disease and for cardiovascular disease,
which is the leading cause of mortality inthis patient population.
v
About Nanox AI
Nanox AI is the deep-learning medical imaginganalytics subsidiary of Nanox.
Nanox.AI solutions are developed to target highly prevalent chronic and acute
diseases affecting largepopulations around the world. Leveraging AI
technology, Nanox AI helps clinicians extract valuable and actionable clinical
insights fromroutine medical imaging that otherwise may go unnoticed,
potentially initiating further medical assessment to establish individual
preventativecare pathways for patients. For more information, please visit
https://www.nanox.vision/ai.
About Nanox
Nanox (NASDAQ: NNOX) is focused on applying itsproprietary medical imaging
technology and solutions to make diagnostic medicine more accessible and
affordable across the globe. Nanox'svision is to increase access, reduce costs
and enhance the efficiency of routine medical imaging technology and
processes, in order toimprove early detection and treatment, which Nanox
believes is key to helping people achieve better health outcomes, and,
ultimately,to save lives. The Nanox ecosystem includes Nanox.ARC- a
multi-source Digital Tomosynthesis system that is cost-effective and
user-friendly;an AI-based suite of algorithms that augment the readings of
routine CT imaging to highlight early signs often related to chronic
disease(Nanox.AI); a cloud-based infrastructure (Nanox.CLOUD); and a
proprietary decentralized marketplace, through Nanox's subsidiary,USARAD
Holdings Inc., that provides remote access to radiology and cardiology
experts; and a comprehensive teleradiology services platform(Nanox.MARKETPLACE).
Together, Nanox's products and services create a worldwide, innovative, and
comprehensive solution that connectsmedical imaging solutions, from scan to
diagnosis. For more information, please visit www.nanox.vision.
iv LeMH, Yeo YH, Li X, Li J, Zou B, Wu Y, et al. 2019 Global NAFLD prevalence: a
systematic review and meta-analysis. Clin Gastroenterol Hepatol2022;20:2809-17.
v Dulai PS, Singh S, Patel J, Soni M, Prokop LJ, Younossi Z, etal. Increased risk of mortality by fibrosis
stage in nonalcoholic fatty liver disease: systematic review and meta-analysis. Hepatology2017;65:1557-65.
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Forward-Looking Statements
This press release contains historical informationand forward-looking
statements within the meaning of The Private Securities Litigation Reform Act
of 1995 with respect to the business,financial condition and results of
operations of Nanox. All statements that are not historical facts contained in
this press release areforward-looking statements. Such statements include, but
are not limited to, any statements relating to the initiation, timing,
progressand results of the Company's research and development, manufacturing,
and commercialization activities with respect to its X-raysource technology
and the Nanox.ARC, the ability to realize the expected benefits of its recent
acquisitions and the projected businessprospects of the Company and the
acquired companies. In some cases, you can identify forward-looking statements
by terminology such asthe words "will," "believe," "expect," "intend," "plan,"
"should,""estimate", "might", "may", "should", "anticipate", "expect","predict"'
"potential" and similar expressions which are intended to identify
forward-looking statements.Forward-looking statements are based on information
the Company has when those statements are made or management's good faith
beliefas of that time with respect to future events and are subject to risks
and uncertainties that could cause actual performance or resultsto differ
materially from those expressed in or suggested by the forward-looking
statements. Factors that could cause actual results todiffer materially from
those currently anticipated include: risks related to (i) Nanox's ability to
complete development of theNanox System; (ii) Nanox's ability to successfully
demonstrate the feasibility of its technology for commercial applications;
(iii)Nanox's expectations regarding the necessity of, timing of filing for,
and receipt and maintenance of, regulatory clearances orapprovals regarding
its technology, the Nanox.ARC and Nanox.CLOUD from regulatory agencies
worldwide and its ongoing compliance with applicablequality standards and
regulatory requirements; (iv) Nanox's ability to realize the anticipated
benefits of the acquisitions, whichmay be affected by, among other things,
competition, brand recognition, the ability of the acquired companies to grow
and manage growthprofitably and retain their key employees; (v) Nanox's
ability to enter into and maintain commercially reasonable arrangements
withthird-party manufacturers and suppliers to manufacture the Nanox.ARC; (vi)
the market acceptance of the Nanox System and the proposedpay-per-scan
business model; (vii) Nanox's expectations regarding collaborations with
third-parties and their potential benefits;(viii) Nanox's ability to conduct
business globally; (ix) changes in global, political, economic, business,
competitive, marketand regulatory forces; (x) risks related to the current war
between Israel and Hamas and any worsening of the situation in Israel;
(xi)risks related to business interruptions resulting from the COVID-19
pandemic or similar public health crises, among other things; and(xii)
potential litigation associated with our transactions.
For a discussion of other risks and uncertainties,and other important factors,
any of which could cause Nanox's actual results to differ from those contained
in the Forward-LookingStatements, see the section titled "Risk Factors" in
Nanox's Annual Report on Form 20-F for the year ended December31, 2022, and
subsequent filings with the U.S. Securities and Exchange Commission. The
reader should not place undue reliance on any forward-lookingstatements
included in this press release.
Except as required by law, Nanox undertakes noobligation to update publicly
any forward-looking statements after the date of this press release to conform
these statements to actualresults or to changes in the Company's expectations.
CONTACTS:
Media Contact:
Ben Shannon
ICR Westwicke
NanoxPR@icrinc.com
Investor Contact:
Mike Cavanaugh
ICR Westwicke
mike.cavanaugh@westwicke.com
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