Hyperfine, Inc. (Nasdaq: HYPR), creator of the Swoop® Portable MR
Imaging System™, the world’s first US FDA-cleared portable magnetic
resonance imaging (MRI) device, announced today that it has
completed registration and notification of the device in Australia
and New Zealand. With this activity, the Swoop system is now
available for purchase in Australia and New Zealand and includes
the US FDA-cleared advanced reconstruction software using deep
learning. Multiple pilot research units have been ordered across
key Australian cities bolstering Hyperfine's entry into these two
markets and laying the foundation for commercial efforts.
Hyperfine is pleased to announce the appointment of Quantum
HealthCare as the company’s distributor for Australia and New
Zealand. Now part of Paragon Care Limited, Quantum is a leading
independent high-end medical equipment distributor across Asia
Pacific. Quantum specializes in state-of-the-art medical imaging
and patient treatment equipment distribution and services for
leading global suppliers. Quantum HealthCare General Manager
Tiffany Chiew said, “Quantum is very excited to be distributing
Hyperfine’s mobile MRI technology in Australia and New Zealand.
Together with the news of our recent merger with Paragon Care, we
are optimistic about the acceptance and growth of Hyperfine’s
innovative technology in the region.”
“Australia and New Zealand have a population of 31 million
people spread across a vast geographic area. Providing relevant and
critical MR imaging services to people of these two countries is
further challenged by the historical all-in-costs of conventional
MRI systems. Swoop runs on regular wall power and is simple to use.
The portable Hyperfine Swoop MRI system requires no special room
build-outs and is available at the patient’s bedside, enabling new
care scenarios. We have been excited to learn of the early success
of Alfred Health and are excited about other upcoming sites
deploying Swoop,” said Dave Scott, president and chief executive
officer of Hyperfine.
The Hyperfine Swoop system has been in use for research purposes
at Alfred Health in Melbourne since mid-late 2021. “In the largest
ICU in the southern hemisphere, point-of-care MR imaging has
impacted the diagnosis and evaluation of intensive care patients in
Melbourne. Reducing the staff and time needed in transporting very
ill patients to the medical imaging department improves outcomes
for patients. The point-of-care MRI also has the advantage of
sparing patients from exposure to ionizing radiation. Alfred Health
is committed to providing state-of-the-art care with the first
institution in Australia to provide point-of-care MRI, CT, US, and
X-ray in our ICU,” said Professor Meng Law, Director of Radiology,
Alfred Health, Director of integrated Biomedical Research in AI and
Neuroimaging, Department of Neuroscience, Monash University.
The Australian National Imaging Facility (NIF) selected the
Swoop system as an industry partner in a two-million-dollar project
to provide state-of-the-art imaging capability for the Australian
research community. NIF’s grid of imaging facilities is distributed
across Australia, offering a range of leading-edge imaging
instrumentation and expertise in the optimal use of imaging
technology to the Australian research community. “The Hyperfine
scanners provide point-of-care imaging that has the potential to
transform access to MRI in rural and remote communities in
Australia. Our project aims to expand their applications using
artificial intelligence and improve accessibility to this
potentially life-saving medical imaging technology for patients
living in rural and remote areas,” said Professor Gary Egan,
Director of Monash Biomedical Imaging in Melbourne, Australia.
The Swoop Portable MR Imaging System is being used worldwide to
address some limitations of current imaging technologies and make
MRI more accessible. Hyperfine designed the system to wheel
directly to a patient’s bedside, plug into a standard electrical
wall outlet, and be controlled by an off-the-shelf tablet. With the
Swoop system, rapid MR imaging is now available at the point of
care, potentially allowing physicians to diagnose and determine
treatment for patients regardless of income or location.
For more information about the Hyperfine Swoop Portable MR
Imaging System, please visit http://www.hyperfine.io.
About Hyperfine and the Swoop
Portable MRI SystemHyperfine, Inc. is the groundbreaking
medical device company that created Swoop, the world’s first US
FDA-cleared portable MRI system. Hyperfine designed Swoop to enable
rapid diagnosis and treatment of all patients regardless of income,
resources, or location, pushing the boundaries of conventional
imaging technology and expanding patient access to life-saving
care. The Swoop Portable MR Imaging System produces high-quality
images at a lower magnetic field strength, allowing clinicians to
quickly scan, diagnose and treat patients in various point-of-care
clinical settings. Swoop can be wheeled directly to the patient’s
bedside, plugged into a standard electrical wall outlet, and
controlled by a tablet. Designed as a complementary system to
conventional MRIs at a fraction of the cost, Swoop captures images
in minutes, providing critical decision-making capabilities across
a variety of clinical settings. For more information about
Hyperfine, please visit https://www.hyperfine.io.
Forward-Looking
StatementsThis presentation includes “forward-looking
statements” within the meaning of the “safe harbor” provisions of
the Private Securities Litigation Reform Act of 1995. Hyperfine’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, Hyperfine’s
expectations with respect to financial results, future performance,
development and commercialization of products and services, the
potential benefits and impact of Hyperfine’s products and services,
potential regulatory approvals, and the size and potential growth
of current or future markets for Hyperfine’s products and services.
Most of these factors are outside of Hyperfine’s control and are
difficult to predict. Factors that may cause such differences
include, but are not limited to: the completion and audit of
Hyperfine’s financial statements for the year ended December 31,
2021; the success, cost and timing of Hyperfine product development
and commercialization activities, including the degree that Swoop
is accepted and used by healthcare professionals; the impact of
COVID-19 on Hyperfine’s business; the inability to maintain the
listing of Hyperfine’s Class A common stock on the Nasdaq following
the recently completed business combination; the inability to
recognize the anticipated benefits of the business combination,
which may be affected by, among other things, competition and
Hyperfine’s ability to grow and manage growth profitably and retain
its key employees; changes in applicable laws or regulations; the
inability of Hyperfine to raise financing in the future; the
inability of Hyperfine 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
Hyperfine to identify, in-license or acquire additional technology;
the inability of Hyperfine to maintain its existing or future
license, manufacturing, supply and distribution agreements; the
inability of Hyperfine to compete with other companies currently
marketing or engaged in the development of products and services
that Hyperfine is currently marketing or developing; the size and
growth potential of the markets for Hyperfine’s products and
services, and its ability to serve those markets, either alone or
in partnership with others; the pricing of Hyperfine’s products and
services and reimbursement for medical procedures conducted using
Hyperfine’s products and services; Hyperfine’s estimates regarding
expenses, future revenue, capital requirements and needs for
additional financing; Hyperfine’s financial performance; and other
risks and uncertainties indicated from time to time in Hyperfine’s
filings with the Securities and Exchange Commission, including
those under “Risk Factors” therein. Hyperfine 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. Hyperfine 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.
Investor Contact
Marissa BychGilmartin Groupmarissa@gilmartinir.com
Media Contact
(US)Aunny De La Rosa-BatheAPCO
Worldwideabathe@apcoworldwide.com
Quantum Healthcare Contact
(Australia and New Zealand)hyperfine@qhealthcare.com.au
outside Australia: +61 2 8011 0430toll-free: 1800 228 118
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