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Lantheus Announces Topline Results for BENEFIT 1 LVEF Clinical Trial
NORTH BILLERICA, Mass.--(BUSINESS WIRE)-- Lantheus Holdings, Inc. (NASDAQ: LNTH) (“Lantheus” or the “Company”), parent company of Lantheus Medical Imaging,
About this update from Lantheus Holdings, Inc.
[{"type":"text","content":" NORTH BILLERICA, Mass.--(BUSINESS WIRE)--\nLantheus Holdings, Inc. (NASDAQ: LNTH) (“Lantheus” or the “Company”), parent company of Lantheus Medical Imaging, Inc. (“LMI”), a leader in the development, manufacture and commercialization of innovative diagnostic imaging agents and products, today announced topline results for the BENEFIT 1 Left Ventricular Ejection Fraction (“LVEF”) clinical trial.\n\n\nTopline Results for the BENEFIT 1 LVEF Clinical Trial\n\n\nThe BENEFIT 1 LVEF clinical trial is one of two Phase 3, open-label, multicenter studies to evaluate LVEF measurement accuracy and reproducibility of DEFINITY® contrast-enhanced and unenhanced echocardiography as compared to non-contrast cardiac magnetic resonance imaging (“CMRI”) used as the truth standard. BENEFIT 1 enrolled 145 subjects. The primary objective of this study was to demonstrate improvement in accuracy in measuring LVEF using DEFINITY contrast-enhanced over unenhanced echocardiography as compared to LVEF measured using CMRI.\n\n\nIn BENEFIT 1, there was no statistically significant improvement in the accuracy of LVEF values for contrast-enhanced echocardiography versus unenhanced echocardiography as compared to CMRI. Analyses of the secondary endpoints revealed no improvement in inter-reader variability between the contrast-enhanced and unenhanced echocardiograms for LVEF assessments. A post-hoc analysis, however, did show statistically significant improvements in left ventricular diastolic, systolic and stroke volume measurements with contrast-enhanced versus unenhanced echocardiography when compared to CMRI.\n\n\n“Although the endpoints for BENEFIT 1 were not met, we will continue to analyze the BENEFIT 1 data,” said Dr. Istvan Molnar, Chief Medical Officer of Lantheus. “When the data from BENEFIT 2 are available, we will compile the data sets to analyze the full results of the trials. We are grateful to the patients, investigators, and trial sites for participating in this trial.”\n\n\n“DEFINITY is the worldwide leading product in the ultrasound contrast market and it remains a proven and preferred imaging agent serving the echocardiography community within its current indication,” said Mary Anne Heino, President and Chief Executive Officer of Lantheus. “DEFINITY’s consistent year-over-year double digit percentage revenue growth demonstrates the value it c...