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August 24, 2020

Sirtex Completes Enrollment of United States RESiN Registry

August 24, 2020—Sirtex Medical US Holdings, Inc. announced that enrollment in the United States RESiN Registry has reached a milestone of 1,650 patients and 12.8 months of follow-up, allowing for a satisfactory number of patients enrolled for meaningful data analysis. The registry is a database of patients with unresectable liver cancer eligible for treatment with the company’s SIR-Spheres yttrium-90 (Y-90) resin microspheres—a targeted radiation therapy for patients with oncologic disorders.

According to Sirtex, the registry is led by Daniel Brown, MD, started enrollment in 2015, and represents one of the largest prospective, multicenter, observational studies conducted in interventional radiology and interventional oncology. The registry’s executive committee will close enrollment at the 45 centers and begin a new phase of data review and evaluation, publication, and presentation. The company expects the registry to provide robust real-world evidence to characterize the effectiveness, safety, and clinical impact of the SIR-Spheres device.

Dr. Brown commented in the company’s announcement, “I am extremely grateful to Sirtex for their support. Their commitment to developing and maintaining this first-of-its-kind interventional oncology registry has been unwavering over the 5 years of the study. As this phase of the project winds down, I am looking forward to future collaborations with Sirtex to advance the data, science, and knowledge around patients treated with SIR-Spheres Y-90 resin microspheres.” Dr. Brown is Professor of Radiology, Vice-Chair of Innovation and Clinical Research, and Chief of Interventional Oncology at Vanderbilt University Medical Center in Nashville, Tennessee.

To date, the RESiN registry has yielded several publications, including oral and poster presentations at international medical oncology and interventional radiology congresses, as well as a recently submitted article, “Incidence and Risk Factors for Sustained Hepatic Function Toxicity 6 Months after Y-90 Radioembolization: Interim Analysis of the Radiation-Emitting SIR-spheres In Non-resectable Liver Tumor (RESIN) Registry.”

With completed enrollment, Sirtex and Vanderbilt will focus efforts to expand the number of publications arising from this database and topic areas of interest, such as an assessment of different pretreatment planning dosimetry methods, orphan tumor outcomes, and specific cohorts of interest.

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