BEDFORD, Mass., June 03, 2024 (GLOBE NEWSWIRE) -- 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 X
2Calais J, et al. J Nucl Med. 2022;63(supple 2):2496
3Gholam 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 Use
aPROMISE 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 Precautions
The 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 Lantheus
Lantheus 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 Statements
This 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:
Lantheus
Mark Kinarney
Vice President, Investor Relations
978-671-8842
ir@lantheus.com
Melissa Downs
Senior Director, External Communications
646-975-2533
media@lantheus.com
