Clinical research, supported by funding from
the Bill & Melinda Gates Foundation, has the potential to make
a profound impact on global maternal and childhood health
Hyperfine, Inc. (Nasdaq: HYPR), the groundbreaking medical
device company that created the Swoop® system, the world's first
FDA-cleared portable magnetic resonance imaging (MRI) system, today
announced an expansion of clinical research to study the
neurological effects of early childhood malnutrition in low and
middle-income countries, with funding support from the Bill &
Melinda Gates Foundation. The goal of the collaborative, multi-year
global study is to address the impact of malnutrition on school
readiness and academic achievement in the future development of
children.
The three-year extension is covered under a new $3 million grant
through which Hyperfine, Inc. plans to make enhancements to the
Swoop® Portable MR Imaging® system to improve the system’s
functionality, software, and data management specifically for use
in remote low and middle-income settings; to continue to support
the research of and optimization of neuroimaging MRI sequences for
neonates and infants; and provide technical support for all Swoop®
systems that are part of the global study. This work will be
carried out by Hyperfine, Inc. engineers and scientists working
hand-in-hand with leading MRI physicists and imaging scientists
also funded by the Bill & Melinda Gates Foundation.
“This work is designed to benefit infants and young children
throughout the world. Children born preterm, small for gestational
age, or who face malnutrition, neglect, or other forms of adversity
are at risk for delayed, impaired, or sub-optimal
neurodevelopment,” said Dr. Khan Siddiqui, Chief Medical Officer at
Hyperfine, Inc. “This investment will fill a critical role in
providing an affordable, scalable method for directly evaluating
the efficacy of interventions to improve infant and child health
and neurodevelopment.”
Magnetic resonance (MR) brain imaging for newborns, infants, and
young children is essential for early assessment of brain
development. In a medical setting, using an MRI at the patient's
bedside can quickly help physicians diagnose and treat issues like
difficulty breathing at birth, infections, brain inflammation, and
other common brain-related problems. Today, high-field MRI machines
are not widely available or accessible in low- and middle-income
countries. There is a need for affordable, easy-to-use imaging to
evaluate neurodevelopmentally focused interventions. We believe
this need is a significant issue in global health.
“Hyperfine, Inc. is building a global network of Swoop® Portable
MR Imaging® systems to make imaging more accessible to patients
around the world. Through our collaboration with the foundation’s
UNITY project, we are actively partnering and learning alongside
researchers and clinicians from Uganda to Bangladesh who see the
immense value of accessible and affordable MR imaging,” said Maria
Sainz, President and CEO of Hyperfine, Inc. “What we are witnessing
firsthand in low- and middle-income countries from this team also
has implications for current and future Swoop® system clinical use
cases in the United States and internationally. We are excited
about the possibilities to improve global health with our Swoop®
system.”
The extension of Hyperfine, Inc.’s work on the Swoop® system and
continued support from the Bill & Melinda Gates Foundation,
which began in March 2020, highlights the power of combining
innovative technology with philanthropic efforts to address global
health challenges. By equipping low- and middle-income settings
with the Swoop® Portable MR Imaging® system, this initiative aims
to close the gap in neurodevelopmental assessment and enable more
targeted interventions, transforming the lives of children affected
by malnutrition.
For more information about the Swoop® Portable MR Imaging®
System, please visit hyperfine.io.
About Hyperfine, Inc. and the Swoop® Portable MR Imaging®
System
Hyperfine, Inc. (Nasdaq: HYPR) is the groundbreaking medical
technology company that created the Swoop® system, the world’s
first FDA-cleared portable magnetic resonance imaging (MRI) system
capable of providing neuroimaging at the point of care. The Swoop®
system received initial U.S. Food and Drug Administration (FDA)
clearance in 2020 as a bedside 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 has been approved for brain imaging in several
countries, including Canada and Australia, has UKCA certification
in the United Kingdom, CE certification in the European Union, and
is also available in New Zealand.
The mission of Hyperfine, Inc. is to revolutionize patient care
globally through transformational, accessible, clinically relevant
diagnostic imaging, and data solutions. 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. Traditionally, access to costly,
stationary, conventional MRI technology can be inconvenient or not
available when needed most. With the portable, ultra-low-field
Swoop® system, Hyperfine, Inc. is redefining the neuroimaging
workflow by bringing brain imaging to the patient’s bedside. For
more information, visit hyperfine.io.
Hyperfine, 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. Hyperfine, Inc. (“the
Company”)’s actual results 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 goals, plans for and potential impact of the
Company’s collaboration with BMGF, the Company’s 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 availability of BMGF funding for our clinical
research program with BMGF; 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/20230518005299/en/
Media Contact Erich Sandoval Health+Commerce
erich@healthandcommerce.com
Investor Contact Marissa Bych Gilmartin Group LLC
marissa@gilmartinir.com
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