Strategic agreements set the stage for further
global adoption of portable MR brain imaging technology, fueling
expansion plans for 2025.
Hyperfine, Inc. (Nasdaq: HYPR), the groundbreaking health
technology company that has redefined brain imaging with the first
FDA-cleared AI-powered portable magnetic resonance (MR) brain
imaging system—the Swoop® system—today announced further global
expansion of its commercial operations through agreements with
experienced distributors to support commercial expansion plans of
the Swoop® system into Turkey, Israel, and Saudi Arabia. These
distribution agreements strengthen the company’s global expansion
strategy, broadening access to MR brain imaging in regions with
large populations, low penetration of MRI, and significant unmet
healthcare needs.
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The Swoop® Portable MR Imaging® System
(Photo: Business Wire)
“We have achieved several milestones throughout 2024 that have
positioned us for significant growth in international markets in
2025,” said David Castiglioni, Hyperfine Chief Commercial Officer.
“Agreements with these new partners build on our existing
distribution networks, giving Hyperfine robust global reach. The
interest from international clinicians and healthcare facilities
reflects the growing global enthusiasm for portable MR brain
imaging and its potential to bridge critical healthcare gaps.”
The new distribution agreements in Turkey, Israel, and Saudi
Arabia add to agreements established earlier in 2024 targeting
future expansion across thirteen European markets, India, Malaysia,
and Indonesia—broadening the reach of Hyperfine to encompass North
America, Europe, Asia, Oceania, and the Middle East. In October
2024, Hyperfine was granted CE approval in Europe for its latest
ninth-generation AI-powered software. This most recent software
approval, combined with the extensive distribution network,
positions Hyperfine for significant growth in 2025 and beyond.
The new distribution partnerships ensure efficient market entry
and afford Hyperfine strong local support for adopting the Swoop®
system. These areas, home to over 100 million people, face
challenges in providing timely neurological care, particularly in
remote and emergency settings lacking access to advanced imaging
equipment. With its portability and cost-effectiveness, the Swoop®
system eliminates barriers posed by conventional MRI systems,
enabling clinicians to deliver high-quality imaging at the point of
care.
“We feel the Swoop® system can play a very valuable role in
advancing neurological care globally,” added Castiglioni.
“International markets have significantly lower penetration of
conventional MRI, and a portable and affordable MR brain imaging
option is a valuable solution to serve large areas of unmet need in
those markets.”
For more information about the Swoop® Portable MR Imaging®
system, please visit hyperfine.io.
About the Swoop® Portable MR Imaging® System
The Swoop® Portable MR Imaging® system is U.S. Food and Drug
Administration (FDA) cleared for brain imaging of patients of all
ages. It is a portable, ultra-low-field magnetic resonance imaging
device for producing images that display the internal structure of
the head where full diagnostic examination is not clinically
practical. When interpreted by a trained physician, these images
provide information that can be useful in determining a diagnosis.
The Swoop® system also has CE certification in the European Union
and UKCA certification in the United Kingdom. The Swoop® system is
commercially available in a select number of international
markets.
About Hyperfine, Inc.
Hyperfine, Inc. (Nasdaq: HYPR) is the groundbreaking health
technology company that has redefined brain imaging with the Swoop®
system—the first FDA-cleared, portable, ultra-low-field, magnetic
resonance brain imaging system capable of providing imaging at
multiple points of professional care. The mission of Hyperfine,
Inc. is to revolutionize patient care globally through
transformational, accessible, clinically relevant diagnostic
imaging. Founded by Dr. Jonathan Rothberg in a technology-based
incubator called 4Catalyzer, Hyperfine, Inc. scientists, engineers,
and physicists developed the Swoop® system out of a passion for
redefining brain imaging methodology and how clinicians can apply
accessible diagnostic imaging to patient care. For more
information, visit hyperfine.io.
The Hyperfine logo, Swoop, and Portable MR Imaging are
registered trademarks of Hyperfine, Inc.
Forward-Looking Statements
This press release includes “forward-looking statements” within
the meaning of the “safe harbor” provisions of the Private
Securities Litigation Reform Act of 1995. Actual results of
Hyperfine, Inc. (the “Company”) may differ from its expectations,
estimates and projections and consequently, you should not rely on
these forward-looking statements as predictions of future events.
Words such as “expect,” “estimate,” “project,” “budget,”
“forecast,” “anticipate,” “intend,” “plan,” “may,” “will,” “could,”
“should,” “believes,” “predicts,” “potential,” “continue,” and
similar expressions (or the negative versions of such words or
expressions) are intended to identify such forward-looking
statements. These forward-looking statements include, without
limitation, the Company’s goals and commercial plans, the benefits
of the Company’s products and services, and the Company’s future
performance and its ability to implement its strategy. These
forward-looking statements involve significant risks and
uncertainties that could cause the actual results to differ
materially from the expected results. Most of these factors are
outside of the Company’s control and are difficult to predict.
Factors that may cause such differences include, but are not
limited to: the success, cost and timing of the Company’s product
development and commercialization activities, including the degree
that the Swoop® system is accepted and used by healthcare
professionals; the impact of COVID-19 on the Company’s business;
the inability to maintain the listing of the Company’s Class A
common stock on the Nasdaq; the Company’s inability to grow and
manage growth profitably and retain its key employees; changes in
applicable laws or regulations; the inability of the Company to
raise financing in the future; the inability of the Company to
obtain and maintain regulatory clearance or approval for its
products, and any related restrictions and limitations of any
cleared or approved product; the inability of the Company to
identify, in-license or acquire additional technology; the
inability of the Company to maintain its existing or future
license, manufacturing, supply and distribution agreements and to
obtain adequate supply of its products; the inability of the
Company to compete with other companies currently marketing or
engaged in the development of products and services that the
Company is currently marketing or developing; the size and growth
potential of the markets for the Company’s products and services,
and its ability to serve those markets, either alone or in
partnership with others; the pricing of the Company’s products and
services and reimbursement for medical procedures conducted using
the Company’s products and services; the Company’s estimates
regarding expenses, revenue, capital requirements and needs for
additional financing; the Company’s financial performance; and
other risks and uncertainties indicated from time to time in
Company’s filings with the Securities and Exchange Commission,
including those under “Risk Factors” therein. The Company cautions
readers that the foregoing list of factors is not exclusive and
that readers should not place undue reliance upon any
forward-looking statements, which speak only as of the date made.
The Company does not undertake or accept any obligation or
undertaking to release publicly any updates or revisions to any
forward-looking statements to reflect any change in its
expectations or any change in events, conditions or circumstances
on which any such statement is based.
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version on businesswire.com: https://www.businesswire.com/news/home/20241217074637/en/
Media Contact Dana Schroeder Health+Commerce
dana@healthandcommerce.com
Investor Contact Marissa Bych Gilmartin Group LLC
marissa@gilmartinir.com
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