[Hyperfine] Hyperfine Receives FDA Clearance for Deep Learning Portable MRI, Defining the Future of
[Hyperfine]
World’s first portable MRI transforms
imaging at the patient’s bedside with deep learning to enable timely diagnosis
and treatment
GUILFORD, CT – November 29, 2021 —
Hyperfine, Inc., creator of the first FDA-cleared portable magnetic resonance
imaging (MRI) device, Swoop®, today announced the FDA 510(k) clearance and
launch of its new advanced image reconstruction technology using deep learning
(DL). The image quality resulting from this innovative approach elevates the
diagnostic value of portable MRI.
Current MRI systems have limitations due to
size, fixed location, cost, and staff training requirements. Hyperfine has
overcome these limitations by rethinking MRI design from the bottom up and
adding smart computing. The result is Swoop, an easy-to-use, portable, and
affordable system costing less than the annual service contract of many
conventional MRI systems.
“Improved image quality through artificial
intelligence, paired with the lower cost and bedside capabilities of Swoop, are
enabling greater access to high-quality MR imaging for patients, regardless of
income, resources, or location,” said Dave Scott, president and chief executive
officer of Hyperfine.
For clinicians, better image quality can
support more accurate and faster diagnoses. For patients, more rapid diagnosis
and treatment can support shorter hospital stays and an improved overall
healthcare experience. With the launch of its deep learning-based advanced
image reconstruction technology, Swoop can deliver crisp, clear T1, T2, and
FLAIR images.
“Swoop is already a game-changer in terms
of its ability to provide MR imaging at a patient’s bedside,” said Dr. Fady
Charbel, Head of the Department of Neurosurgery at the University of Illinois
of Chicago. “With the integration of deep learning-based image reconstruction,
clinicians can now visualize anatomy and pathology more clearly and with
increased confidence enabling diagnosis in a more expeditious fashion, critical
for the treatment of acute neurological conditions.
In January, Hyperfine received FDA
clearance for its advanced artificial intelligence (AI) application. This AI
technology measures brain structure and pathology in images acquired by Swoop
through tools featuring automatic measurement of ventricular volume, brain extraction,
brain alignment, and midline shift— which can be used by clinicians to diagnose
and measure acute neurological conditions at a patient’s bedside.. With the
addition of deep learning-based advanced image reconstruction, Hyperfine has
significantly improved image quality from the Swoop system and expects to
continue to do so.
For more information about the Hyperfine
Swoop® Portable MR Imaging SystemTM, please visit http://www.hyperfine.io.
About Hyperfine and the Swoop Portable MR
Imaging System
Hyperfine, Inc. is the groundbreaking
medical device company that created Swoop, the world’s first FDA-cleared
portable MRI system. Hyperfine designed Swoop to enable rapid diagnoses and
treatment for every patient 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 clinical settings. Swoop
can be wheeled directly to the patient’s bedside, plugged into a standard
electrical wall outlet, and controlled by an iPad®. Designed as a complementary
system to conventional MRIs at a fraction of the cost, Swoop captures images in
minutes, providing critical decision-making capabilities in emergency
departments (ED), operating rooms (OR) outside the sterile field, and intensive
care units (ICU), among others.
Important Information about the Business
Combination and Where to Find It
In connection with the proposed business
combination (the “Business Combination”) between HealthCor Catalio Acquisition
Corp. (the “HealthCor”), Hyperfine, Inc. (“Hyperfine”) and Liminal Sciences,
Inc. (“Liminal”), HealthCor has filed with the Securities and Exchange
Commission (the “SEC”) a registration statement on Form S-4 (as amended, the
“Registration Statement”), which includes a preliminary proxy
statement/prospectus and will include a definitive proxy statement/prospectus,
and certain other related documents, which will be both the proxy statement to
be distributed to holders of HealthCor’s ordinary shares in connection with
HealthCor’s solicitation of proxies for the vote by HealthCor’s shareholders with
respect to the Business Combination and other matters as may be described in
the Registration Statement, as well as the prospectus relating to the offer and
sale of the securities of HealthCor to be issued in the Business Combination.
HealthCor’s shareholders and other interested persons are advised to read the
preliminary proxy statement/prospectus included in the Registration Statement
and the amendments thereto and the definitive proxy statement/prospectus, when
available, as well as other documents filed with the SEC in connection with the
Business Combination, as these materials will contain important information
about the parties to the Business Combination Agreement, HealthCor and the
Business Combination. After the Registration Statement is declared effective,
the definitive proxy statement/prospectus and other relevant materials for the
Business Combination will be mailed to shareholders of HealthCor as of a record
date to be established for voting on the Business Combination and other matters
as may be described in the Registration Statement. Shareholders will also be
able to obtain copies of the preliminary proxy statement/prospectus, the
definitive proxy statement/prospectus, and other documents filed with the SEC
that will be incorporated by reference therein, without charge, once available,
at the SEC’s website at www.sec.gov. In addition, the documents filed by
HealthCor may be obtained free of charge from HealthCor’s website at
www.hcspac.com or by written request to HealthCor at ir@hccspac.com.
Participants in the Solicitation
HealthCor and its directors and executive
officers may be deemed participants in the solicitation of proxies from
HealthCor’s shareholders with respect to the Business Combination. You can find
information about HealthCor’s directors and executive officers and their
ownership of HealthCor’s securities in the Registration Statement for the
Business Combination, which is available free of charge at the SEC’s website at
www.sec.gov. Additional information regarding the interests of such
participants is contained in the Registration Statement.
Hyperfine, Liminal and their respective
directors and executive officers may also be deemed to be participants in the
solicitation of proxies from the shareholders of HealthCor in connection with
the Business Combination. A list of the names of such directors and executive
officers and information regarding their interests in the Business Combination
is contained in the Registration Statement.
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. HealthCor’s,
Hyperfine’s and Liminal’s actual results may differ from their 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 future performance, development and commercialization of products and
services; and the potential benefits and impact of Hyperfine’s and the combined
company’s products and services. 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
HealthCor’s, Hyperfine’s and Liminal’s control and are difficult to predict.
Factors that may cause such differences include, but are not limited to: (1)
the ability of HealthCor, Hyperfine and Liminal to meet the closing conditions
in the Business Combination Agreement, including due to failure to obtain
approval of the shareholders of HealthCor, Hyperfine and Liminal or certain
regulatory approvals, or failure to satisfy other conditions to closing in the
Business Combination Agreement; (2) the occurrence of any event, change or
other circumstances, including the outcome of any legal proceedings that may be
instituted against HealthCor, Hyperfine or Liminal following the announcement
of the Business Combination Agreement and the transactions contemplated
therein, that could give rise to the termination of the Business Combination
Agreement or could otherwise cause the transactions contemplated therein to
fail to close; (3) the inability to obtain or maintain the listing of the
combined company’s Class A common stock on the Nasdaq Stock Market, as
applicable, following the Business Combination; (4) the risk that the Business
Combination disrupts current plans and operations as a result of the
announcement and consummation of the Business Combination; (5) the inability to
recognize the anticipated benefits of the Business Combination, which may be
affected by, among other things, competition and the ability of the combined
company to grow and manage growth profitably and retain its key employees; (6)
costs related to the Business Combination; (7) changes in applicable laws or
regulations; (8) the inability of the combined company to raise financing in
the future; (9) the success, cost and timing of Hyperfine’s, Liminal’s and the
combined company’s product development and commercialization activities,
including the degree that Swoop is accepted and used by healthcare
professionals; (10) the inability of Hyperfine, Liminal or the combined company
to obtain and maintain regulatory clearance or approval for their products, and
any related restrictions and limitations of any cleared or approved product; (11)
the inability of Hyperfine, Liminal or the combined company to identify,
in-license or acquire additional technology; (12) the inability of Hyperfine,
Liminal or the combined company to maintain Hyperfine’s or Liminal’s existing
or future license, manufacturing, supply and distribution agreements; (13) the
inability of Hyperfine, Liminal or the combined company to compete with other
companies currently marketing or engaged in the development of products and
services that Hyperfine or Liminal is currently marketing or developing; (14)
the size and growth potential of the markets for Hyperfine’s, Liminal’s and the
combined company’s products and services, and each of their ability to serve
those markets, either alone or in partnership with others; (15) the pricing of
Hyperfine’s, Liminal’s and the combined company’s products and services and
reimbursement for medical procedures conducted using Hyperfine’s, Liminal’s and
the combined company’s products and services; (16) Hyperfine’s, Liminal’s and
the combined company’s estimates regarding expenses, future revenue, capital
requirements and needs for additional financing; (17) Hyperfine’s, Liminal’s
and the combined company’s financial performance; (18) the impact of COVID-19
on Hyperfine’s and Liminal’s businesses and/or the ability of the parties to
complete the Business Combination; and (19) other risks and uncertainties
indicated from time to time in the proxy statement/prospectus relating to the
Business Combination, including those under “Risk Factors” in the Registration
Statement, and in HealthCor’s other filings with the SEC. HealthCor, Hyperfine
and Liminal caution that the foregoing list of factors is not exclusive, and
they caution readers not to place undue reliance upon any forward-looking
statements, which speak only as of the date made. HealthCor, Hyperfine and
Liminal do 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.
No Offer or Solicitation
This press release shall not constitute a
solicitation of a proxy, consent or authorization with respect to any
securities or in respect of the Business Combination. This press release shall
also not constitute an offer to sell or the solicitation of an offer to buy any
securities, nor shall there be any sale of securities in any states or
jurisdictions in which such offer, solicitation or sale would be unlawful prior
to registration or qualification under the securities laws of any such
jurisdiction. No offering of securities shall be made except by means of a
prospectus meeting the requirements of the Securities Act of 1933, as amended.
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Media Contacts
Emily Barnes
APCO Worldwide
ebarnes@apcoworldwide.com