NANO-X IMAGING LTD (“Nanox” or the “Company,” Nasdaq: NNOX), an
innovative medical imaging technology company, today announced that
it has received 510(k) clearance from the U.S. Food and Drug
Administration (FDA) for its Nanox.ARC, a stationary X-ray system
intended to produce tomographic images for general use including
human musculoskeletal system, pulmonary, intra-abdominal, and
paranasal sinus indications, adjunctive to conventional
radiography, on adult patients.
The Nanox.ARC features a proprietary digital X-ray source,
representing a significant advancement in X-ray technology. The
Nanox.ARC utilizes advanced tomosynthesis technology with a cold
cathode to create a more comprehensive, sliced three-dimensional
view of the body, enhancing visualization with multiple layers of
images and reducing the super-imposition of structures often seen
in 2D X-rays.
“With this FDA clearance, we can now offer U.S. healthcare
providers significantly broader imaging capabilities that are akin
to commonly used traditional X-ray devices,” said Erez Meltzer,
Nanox Chief Executive Officer and Acting Chairman. “Our mission is
to provide healthcare practices with a transformative imaging
advantage with the Nanox.ARC – an accessible, cost-effective
solution that not only provides advanced diagnostic imaging
capabilities but also elevates overall patient care. We look
forward to bringing this technology to more healthcare facilities
throughout the country.”
The Company believes the new FDA-cleared indications will help
broaden Nanox. ARC’s commercial expansion in the U.S., where it is
currently deployed at multiple healthcare facilities across seven
states. Worldwide, there are a few dozen units in various stages of
shipments and deployments for both commercial and clinical
uses.
“The installation of the Nanox.ARC at our facility marks a
significant leap forward in our diagnostic capabilities,” said
Sherri Donaldson, COO at Diagnostic Radiology Institute of Kansas
City, located in Mission, Kansas. “This technology allows us to
provide our patients with advanced imaging services, potentially
reducing wait times and improving the overall patient experience.
We're excited to be at the forefront of this technological
advancement in medical imaging.”
The Nanox.ARC is intended for use in professional healthcare
facilities or radiological environments, such as hospitals,
clinics, imaging centers and other medical practices, and is
operated by trained radiographers, radiologists and physicians. It
is designed to allow easy and efficient integration into current
clinical workflows. The Nanox.ARC has the potential benefits of
reducing patient wait times, enabling faster care and more
efficient diagnosis, while also potentially reducing the need to
visit a separate imaging facility.
“Digital tomosynthesis provides added value in certain clinical
situations. Musculoskeletal, thoracic and abdominal imaging all
have use cases that may be best served by digital tomosynthesis
compared to CT or radiography,” said Greg Kicska M.D., Ph.D,
Assistant Professor at Harborview Medical Center and Nanox Advisory
Board Member. “The Nanox system is also unique in that it doesn’t
have as large a footprint as traditional X-ray machines, doesn’t
require as much power and utilizes a matrix pattern that blurs out
structural noise, making images more clean.”
About Nanox
Nanox (NASDAQ: NNOX) is focused on driving the world’s
transition to preventive health care by bringing a full solution of
affordable medical imaging technologies based on advanced AI and
novel digital source.
Nanox's vision encompasses expanding the reach of Nanox
technology both within and beyond hospital settings, providing a
seamless end-to-end solution from scan to diagnosis, leveraging AI
for smarter diagnostics and maintaining a clinically-driven
approach. The Nanox ecosystem includes Nanox.ARC – a multi-source
digital tomosynthesis system that is cost-effective and
user-friendly; Nanox.AI – an AI-based suite of algorithms that
augment the readings of routine CT imaging to highlight early signs
often related to chronic diseases; Nanox.CLOUD – a cloud-based
software platform that manages and stores data collected by Nanox
devices, and provides users with tools for in-depth imaging
analysis; Nanox.MARKETPLACE – 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. By improving early
detection and treatment, Nanox aims to enhance better health
outcomes worldwide. 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 the Company’s research and development,
manufacturing, and commercialization activities with respect to its
X-ray source technology and the Nanox.ARC, the ability to realize
the expected benefits of its recent acquisitions and the projected
business prospects of the Company and the acquired companies. 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 the Company 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 (i) Nanox’s
ability to complete development of the Nanox 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 or approvals regarding its
technology, the Nanox.ARC and Nanox.CLOUD from regulatory agencies
worldwide and its ongoing compliance with applicable quality
standards and regulatory requirements; (iv) Nanox’s ability to
realize the anticipated benefits of the 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 retain their key employees; (v) Nanox’s ability to
enter into and maintain commercially reasonable arrangements with
third-party manufacturers and suppliers to manufacture the
Nanox.ARC; (vi) the market acceptance of the Nanox System and the
proposed pay-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,
market and 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-Looking Statements,
see the section titled “Risk Factors” in Nanox’s Annual Report on
Form 20-F for the year ended December 31, 2023, and subsequent
filings with the U.S. Securities and Exchange Commission. The
reader should not place undue reliance on any forward-looking
statements included in this press release. 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 the
Company’s expectations.
Contacts
Media Contact:Ben ShannonICR
HealthcareNanoxPR@icrinc.com
Investor Contact:Mike CavanaughICR
Healthcaremike.cavanaugh@westwicke.com
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