The Swoop® Portable MR Imaging® system shows
faster time-to-scan compared to conventional MRI and good
specificity in emergency stroke care
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 the presentation of
interim data supporting the role portable ultra-low-field MRI can
play in acute stroke workup in a hospital emergency department
setting.
The findings from the study, titled Interim Analysis from Single
Centre Observational Study of Ultra-Low Field Portable MRI in Acute
Stroke Diagnostic Workup, were presented by Keith Muir, MD, of the
University of Glasgow, during a scientific session at the 2024
European Society of Neuroradiology (ESNR) Annual Meeting.
This study, which includes a subset of patients from phase one
of the prospective, international, multi-site ACTION PMR (Acute
Ischemic Stroke Detection with Portable MR) study, analyzed images
from the ultra-low-field Swoop® MR brain imaging system to assess
the system’s performance in acute care stroke workup as compared to
the current standard of care. The analysis compared time-to-scan,
diagnostic performance, specificity, and patient experience between
ultra-low-field MRI, conventional MRI, and head CT.
Key findings showed that the Swoop® system was dramatically
faster than conventional MRI, with a median time-to-scan of 2.5
hours compared to 27.7 hours. The data also demonstrated
reliability in acute stroke diagnosis with comparable diagnostic
performance compared to head CT and good specificity when compared
to routine clinical MRI (1.5T). Further, nearly all patients
reported a positive experience with the Swoop® system.
The conclusion states, “This interim analysis demonstrates that
the portable [ultra-low-field] MRI system is a promising tool for
the acute stroke diagnostic workup in an emergency department
setting. The improved time to imaging compared to routine MRI could
facilitate quicker decision-making in acute stroke management.
Additionally, the high tolerance rate among patients underscores
its potential usability in a clinical environment. The findings
suggest that portable [ultra-low-field] MRI could enhance stroke
diagnosis accessibility and efficiency, particularly in settings
where conventional MRI availability is limited.”
Dr. Edmond Knopp, Vice President of Medical Affairs at
Hyperfine, commented, “Being at ESNR in Paris this year and
showcasing our Swoop® system, we witnessed the growing interest and
enthusiasm across the European neuroradiology community. This
excitement was most notable when the attendees had the opportunity
to see the system up close and personal. We were very pleased with
Dr. Muir and his team’s participation in the ACTION PMR stroke
study, and it was great to have Dr. Muir share exceptional data
acquired during the study. Their findings highlight the potential
of the Swoop® system’s clinical impact in improving stroke
diagnosis and treatment.”
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 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.
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. 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240923338323/en/
Media Contact Dana Schroeder Health+Commerce
dana@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 11 2024 まで 12 2024
Hyperfine (NASDAQ:HYPR)
過去 株価チャート
から 12 2023 まで 12 2024
