Strategic focus on India aims to make the
Swoop® portable MR brain imaging system commercially available in a
vast and underserved MRI market
Hyperfine, Inc. (Nasdaq: HYPR), the groundbreaking health
technology company that has redefined brain imaging with the first
FDA-cleared portable magnetic resonance (MR) brain imaging
system—the Swoop® system—today announced it has entered into a
distribution agreement with Radiosurgery Global, Ltd. to develop
the market in India. The distribution agreement also includes the
countries of Malaysia, Indonesia, and Singapore through future
expansion, offering Hyperfine, Inc. a significantly increased
presence in Asia.
The clinical value of the Swoop® system is applicable globally
as Hyperfine, Inc. aims to expand overall access and availability
of MRI. In India, where there are fewer than 5,000 MRI scanners for
a population exceeding 1.4 billion (approximately 3.5 MRI scanners
per million inhabitants as compared to 38 per million in the U.S.),
there is a growing need for specialized healthcare facilities and
advanced diagnostic tools due to the increasing prevalence of
chronic diseases like stroke and brain tumors. The current
healthcare infrastructure, particularly in critical care and
emergency settings, is under-equipped, with only fifteen percent of
existing trauma centers having MRI capabilities. This gap
highlights a substantial opportunity for introducing portable MR
brain imaging systems that can meaningfully improve adult and
pediatric care in urban and remote sites of care.
“Expanding commercially to Asia with a focus on India is an
important element of our international strategy. We have begun
preparing for the regulatory approval process through the CDSCO and
are excited to partner with an experienced and capable group like
Radiosurgery Global, Ltd. to drive commercial impact in 2025 and
beyond,” said Maria Sainz, President and CEO of Hyperfine, Inc. “We
believe that by expanding into global markets, we are not only
revolutionizing healthcare delivery but also significantly
impacting patient outcomes. We are committed to leveraging our
expertise and partnerships to drive positive change in global brain
health.”
“This partnership marks a significant crossroads for the entire
region as we bring state-of-the-art portable MR brain imaging
technology within reach of vast, underserved populations,” said
Kapil Kalra, Managing Director of Radiosurgery Global, Ltd.
“The innovative Swoop® system aligns perfectly with our mission
to democratize healthcare access in over 69,000 public and private
hospitals across India, providing clinicians with unprecedented
diagnostic imaging capabilities even in the most remote areas. We
are excited about its enormous potential to enhance patient care
nationwide,” said Timon Dressler, Managing Director of Radiosurgery
Global, Ltd.
The expansion into global markets is supported by the company’s
strong track record of securing international approvals for the
Swoop® system. In 2023, Hyperfine, Inc. obtained CE certification
under the EU MDR and UKCA certification in the United Kingdom for
its latest hardware and eighth-generation AI-powered software. In
May of 2024, the company announced the appointment of distributors
in France, the United Kingdom, and Italy. Hyperfine, Inc. plans to
continue its commercial expansion in partnership with Radiosurgery
Global, Ltd. supporting future marketing submissions in India.
The system the company is introducing to the European and Indian
markets is commercialized in the U.S. and uses the highest
performing Swoop® system software to date in terms of image quality
and usability. Introducing the Swoop® system into
international markets is a significant step in supporting the
commercial growth of Hyperfine, Inc. The Swoop® system could expand
the existing imaging market with its transformative, affordable,
and accessible platform to serve more clinicians and patients
needing brain imaging. The versatility of the Swoop® system
across multiple sites of care offers a solution to patients in
varied settings who may not have access to the latest MRI
technologies.
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 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/20240528157535/en/
Media Contact Shay Smith Health+Commerce
shay@healthandcommerce.com
Investor Contact Marissa Bych Gilmartin Group LLC
marissa@gilmartinir.com
Hyperfine (NASDAQ:HYPR)
過去 株価チャート
から 10 2024 まで 11 2024
Hyperfine (NASDAQ:HYPR)
過去 株価チャート
から 11 2023 まで 11 2024
