Today’s presentation at CTAD, a leading international
Alzheimer's conference, expands research supporting the value of
ultra-low-field MRI in monitoring amyloid-related imaging
abnormalities (ARIA).
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
additional research data and images using the Swoop® system to
image patients with Alzheimer’s disease who are part of the
observational, investigator-initiated CARE PMR study.
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The Swoop® Portable MR Imaging® System
(Photo: Business Wire)
The Swoop® system is gaining international exposure, with
growing evidence supporting the use of Swoop® system images to help
in the detection of amyloid-related imaging abnormalities (ARIA-E)
when monitoring Alzheimer’s patients receiving amyloid-targeting
therapy. Recent presentations at significant Alzheimer’s meetings,
including the Alzheimer’s Association International Conference
(AAIC) in Philadelphia, AAIC in Tokyo, and the Clinical Trials on
Alzheimer’s Disease (CTAD) conference in Madrid (presented on
October 31st), have showcased the potential value of the Swoop®
system in Alzheimer’s patient management.
The presentation today at CTAD featured research from Washington
University in St. Louis, a leading center in Alzheimer’s disease
research using ultra-low-field MR imaging with the Swoop® system
and an actively enrolling center in the CARE PMR study. The authors
shared their experiences using Swoop® system images to detect
ARIA-E in patients undergoing Lecanemab therapy. The presentation
showcased multiple cases comparing images obtained with the
ultra-low-field Swoop® portable MR brain imaging system with images
from a high-field 3 tesla MRI scanner. The Swoop® system images,
processed using the latest advancements in AI-driven research
software, demonstrated impressive image quality that shows promise
for use in assisting physicians in detecting ARIA-E.
The presentation conclusions stated that the Swoop system
“presents a promising and cost-effective alternative to the
conventional 3T MRI, with the added advantage of workflow
optimization.” Further, the authors noted, “This study highlights
the potential of innovative imaging technologies to advance patient
care and monitor neurodegenerative conditions.”
The CARE PMR (Capturing ARIA Risk Equitably with Portable MR)
study is a collection of data from multiple sites assessing the
clinical utility and workflow benefits of using Swoop® system
images to detect amyloid-related imaging abnormalities (ARIA) in
Alzheimer’s patients receiving amyloid-targeting therapy.
Dr. Edmond Knopp, Chief Medical Officer at Hyperfine, expressed
his enthusiasm for the ongoing research. He stated, “I want to
congratulate Washington University for their leadership in
Alzheimer’s research, particularly with the use of portable MR
brain imaging. The impressive image quality achievable with our
ultra-low-field MRI technology opens up the potential to enable the
ability to provide critical diagnostic information for patients
with Alzheimer’s disease across many sites of professional care,
including infusion centers and clinics that currently cannot offer
on-site imaging capabilities. These presentations provide early
evidence that portable MRI could transform Alzheimer’s disease
management.”
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.
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/20241031241209/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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