Two new executive roles position Hyperfine to
drive the adoption of the Swoop® system in hospital settings and
expand into the office setting, laying the foundation for
significant growth in 2025 and beyond.
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 the appointment of
Chi Nguyen as Vice President of Office Strategy and Partnerships
and Rafael Donnay as Vice President of Hospital Strategy and Health
Economics to provide leadership in key growth areas. These
strategic leadership appointments bolster the capability of
Hyperfine to drive Swoop® system commercial adoption in hospital
inpatient and outpatient settings and expand to neurology office
settings.
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The Swoop® Portable MR Imaging® System
(Photo: Business Wire)
Chi Nguyen will lead the company’s office strategy, drawing on
her extensive experience in developing markets for disruptive
technologies. The new MRI standards issued by the Intersocietal
Accreditation Commission (IAC) in November 2024 open the door for
accredited neurology offices to secure CMS reimbursement for MRI
scans using the Swoop® system. This milestone positions Hyperfine
to expand into new sites of care, including neurology
offices—representing nearly 2,400 potential locations in the U.S.
alone. By bringing advanced MR brain imaging directly to these
professional healthcare settings, Hyperfine will significantly
enhance patient access and convenience by enabling MR brain imaging
during routine clinic visits. To lay the foundation for this
expansion, Ms. Nguyen will oversee an office pilot program in
preparation for a full commercial rollout scheduled for
mid-2025.
Rafael Donnay will lead the company’s hospital strategy,
leveraging his expertise in commercialization, market development
of new technologies, and health economics to position the Swoop®
system as an essential tool in a range of hospital settings. With a
focus on market expansion, the company is targeting over 9,600
potential sites of care in the U.S. alone, including 4,000 critical
care units and 5,600 emergency departments. With a track record of
successful commercialization of AI-powered point-of-care EEG and
extensive experience in the neurovascular space, Mr. Donnay will
focus on integrating the Swoop® system into hospital workflows to
optimize patient care.
Beyond the hospital and office business verticals, growth in
2025 will be driven by international expansion efforts, supported
by the recent CE approval of the latest AI-powered Swoop® system
software. This milestone positions Hyperfine for broader European
commercial expansion of the Swoop® system, bringing cutting-edge
brain imaging technology to new global markets.
Maria Sainz, President and CEO of Hyperfine, commented, “The
addition of Chi and Rafael to our leadership team is a pivotal step
in our expansion and growth strategy. Their expertise in market
development, commercialization of disruptive technologies, and
health economics will be instrumental as we expand the Swoop®
system’s reach. With their leadership, Hyperfine is well-positioned
to drive growth and transform care delivery in hospital and
neurology office settings.”
For more information about the Swoop® Portable MR Imaging®
system, please visit hyperfine.io.
About Chi Nguyen
Chi Nguyen is a seasoned medical device executive with over two
decades of experience in strategy, marketing, and market
development, specializing in the commercialization of disruptive
medical technologies. She previously served as Vice President of
Marketing at NeuroPace, Inc., where she successfully led market
expansion efforts from early launch through IPO. Her earlier roles
include Spinal Modulation, Acclarent/Johnson & Johnson, Guidant
Corporation, and Bain & Company. Chi holds an MBA from Stanford
Graduate School of Business and a BA from Yale University.
About Rafael Donnay
Rafael Donnay, with over twenty years of experience in medical
technology, is driven by a passion to improve healthcare using
innovative and disruptive technologies. He most recently served as
Senior Vice President of Product and Reimbursement at CeriBell
Inc., a leadership team member from Series A to IPO. Rafael's prior
marketing leadership roles include Philips, Stryker Neurovascular,
and Medtronic. He holds an MBA from The Wharton School, an MS from
Stanford University, and a BS from Columbia University.
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/20241203244752/en/
Media Contact Dana Schroeder Health+Commerce
dana@healthandcommerce.com Investor Contact Marissa Bych
Gilmartin Group LLC marissa@gilmartinir.com
Hyperfine (NASDAQ:HYPR)
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Hyperfine (NASDAQ:HYPR)
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から 12 2023 まで 12 2024