Lantheus’ AI-Enabled aPROMISE Now Available on Siemens Healthineers’ syngo.via platform
June 03 2024 - 7:30AM
Lantheus Holdings, Inc. (“Lantheus”) (NASDAQ: LNTH), the leading
radiopharmaceutical-focused company committed to enabling
clinicians to Find, Fight and Follow disease to deliver better
patient outcomes, today announced that aPROMISE, its AI-enabled
FDA-cleared medical device software, is now available on the
syngo.via platform, from Siemens Healthineers, one of the leading
workstation systems. Siemens Healthineers will be demonstrating the
integrated solution at the upcoming annual Society of Nuclear
Medicine and Molecular Imaging (SNMMI) annual meeting in Toronto
June 8-11, 2024.
aPROMISE is a deep learning-enabled, FDA-cleared medical device
software that provides quantitative total disease burden on PSMA
PET/CT images, including those obtained using PYLARIFY®
(piflufolastat F 18) PET/CT.1 In planned prospective and
independent validation studies, aPROMISE has demonstrated rapid
lesion detection and standardized quantitative tumor burden
biomarkers in PSMA PET/CT imaging.2 Recent clinical studies have
shown that total quantitative burden with aPROMISE supports patient
selection for PSMA radioligand therapy (RLT) and automates
monitoring response over time. 3,4
“Given the expanding treatment options for advanced prostate
cancer, especially PSMA-targeted radioligand therapy, there is an
increasing need to understand treatment eligibility and response
using PSMA PET. The deep learning-enabled analysis of PSMA PET/CT
images by aPROMISE can generate clinically relevant imaging
biomarkers, potentially expanding the clinical utility of PSMA PET
in managing prostate cancer," said Oliver Sartor, M.D., Director of
Radiopharmaceutical Trials and Professor of Medical Oncology at the
Mayo Clinic in Rochester, Minnesota.
The Siemens Healthineers portfolio of positron emission
tomography (PET) and single-photon emission computed tomography
(SPECT) scanners play a central role in clinical decision-making
and therapy evaluation. Siemens Healthineers’ syngo.via is the
vendor-neutral imaging software platform for 2D, 3D, and 4D reading
and advanced visualization of medical images. The aPROMISE solution
will be integrated on the syngo.via platform, one of the leading
workstation systems, and will be available via its OpenApps Digital
Marketplace. This will further facilitate nuclear medicine clinical
workflow across the PET sites in the U.S.
1FDA clearance letter for aPROMISE X2Calais J, et al. J Nucl
Med. 2022;63(supple 2):24963Gholam B, et al. J Nucl Med.
2023;64(supple 1):P228 4Benitez, et al. J of Clinical Oncology.
2024.42.4(supple 48)
aPROMISE Indications for UseaPROMISE is
FDA-cleared in the U.S. and CE-marked in the European Union.
aPROMISE is intended to be used by healthcare professionals and
researchers for acceptance, transfer, storage, image display,
manipulation, quantification and reporting of digital medical
images. The system is intended to be used with images acquired
using nuclear medicine (NM) imaging, using PSMA PET/CT. The device
provides general Picture Archiving and Communications System (PACS)
tools as well as a clinical application for oncology including
marking of regions of interest and quantitative analysis.
aPROMISE Warnings and PrecautionsThe
quantification analysis results provided by aPROMISE are intended
to be used as complementary information together with other patient
information. The user of aPROMISE shall not rely solely on the
information provided by the application for diagnostic or treatment
decisions. Quantitative measurements (Total SUVmean, Volume, SUVmax
and Lesion number, aPSMAscore) are only appropriate for PSMA PET/CT
images. aPROMISE user should not select hotspots for studies with
images that do not fulfill the Quality Control requirements. In
such cases, user can create and sign a report indicating that the
review cannot be done due to image quality deficiencies.
About LantheusLantheus is the leading
radiopharmaceutical-focused company, delivering life-changing
science to enable clinicians to Find, Fight and Follow disease to
deliver better patient outcomes. Headquartered in Massachusetts
with offices in Canada and Sweden, Lantheus has been providing
radiopharmaceutical solutions for more than 65 years. For more
information, visit www.lantheus.com.
Safe Harbor for Forward-Looking and Cautionary
StatementsThis press release contains “forward-looking
statements” within the meaning of the Private Securities Litigation
Reform Act of 1995, as amended, that are subject to risks and
uncertainties and are made pursuant to the safe harbor provisions
of Section 27A of the Securities Act of 1933, as amended, and
Section 21E of the Securities Exchange Act of 1934, as amended.
Forward-looking statements may be identified by their use of terms
such as “can,” “expanding,” “focus”, “will” and other similar
terms. Such forward-looking statements are based upon current
plans, estimates and expectations that are subject to risks and
uncertainties that could cause actual results to materially differ
from those described in the forward-looking statements. The
inclusion of forward-looking statements should not be regarded as a
representation that such plans, estimates and expectations will be
achieved. Readers are cautioned not to place undue reliance on the
forward-looking statements contained herein, which speak only as of
the date hereof. The Company undertakes no obligation to publicly
update any forward-looking statement, whether as a result of new
information, future developments or otherwise, except as may be
required by law. Risks and uncertainties that could cause our
actual results to materially differ from those described in the
forward-looking statements are discussed in our filings with the
Securities and Exchange Commission (including those described in
the Risk Factors section in our Annual Reports on Form 10-K and our
Quarterly Reports on Form 10-Q).
Contacts:LantheusMark
KinarneyVice President, Investor
Relations978-671-8842ir@lantheus.com
Melissa DownsSenior Director, External
Communications646-975-2533media@lantheus.com
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