"The decision to reimburse QuiremSpheres® is very positive as it expands the available options to treat patients with advanced unresectable liver cancer," said Prof. Dr. Marc Peeters, Head of the Oncology Department, Antwerp University Hospital (UZA) & Antwerp University (UA).
"The recent decision in Belgium represents a positive development for QuiremSpheres® and for SIRT treatment in Belgium, as access to this innovative technology for clinicians and patients will be facilitated," said Peter Coenen, President of Interventional systems Terumo EMEA. "We strongly believe that the unique imaging capabilities of QuiremSpheres® can be a game changer in the field of SIRT and this reimbursement decision is an important milestone towards realizing its full potential."
QuiremSpheres®, the next generation of SIRT microspheres, are the only commercially available microspheres that contain the radioactive isotope Holmium-166. Recent trials have shown the safety [1] and efficacy [2] of holmium microspheres for the treatment of advanced liver cancer.
Unlike current microspheres used for SIRT, QuiremSpheres® can be visualized in low concentrations by means of SPECT and MRI. This allows clinicians to assess quantitatively the distribution of microspheres in the liver, enabling accurate evaluation of treatment directly after the radio-embolization procedure.
Jan Sigger, CEO of Quirem Medical B.V., the manufacturer of QuiremSpheres®, said: "The decision of the Belgian authorities to fully reimburse QuiremSpheres® is consistent with the fact that our product uses the same mode of action and the same radiotherapeutic principles to target liver cancer as existing products on the market. Additionally, we believe that usage of QuiremSpheres® can further enhance treatment outcome by the unique possibility to visualize and quantify the intrahepatic dose distribution right after the SIRT procedure."
About Terumo
Tokyo-based Terumo Corporation is one of the world's leading medical device manufacturers with over US$5 billion in sales and operations in more than 160 nations. Founded in 1921, the company develops, manufactures and distributes world-class medical devices including products for use in cardiothoracic surgery, interventional procedures and transfusion medicine; the company also manufactures a broad array of syringe and hypodermic needle products for hospital and physician office use. Terumo contributes to society by providing valued products and services to the health care market and by responding to the needs of health care providers and the people they serve. Terumo Corporation's shares are listed on the first section of the Tokyo Stock Exchange (No. 4543, Reuters symbol <4543.T>, or Bloomberg 4543: JP) and is a component of the Nikkei 225, Japan's leading stock index.
About Quirem
Quirem Medical is an emerging medical device company with a mission to develop the next generation microspheres for targeted interventional treatment of liver malignancies. It is based in Deventer, the Netherlands and is a spin-off company from the University Medical Center in Utrecht.
[1] The recommended whole liver dose of 60Gy was identified as the maximum tolerated radiation dose in a phase I trial (no dose-limiting toxicity occured in the 60Gy cohort) Smits et al, Lancet Oncol. 2012, Oct;13(10):1025-34. ClinicalTrials.gov Identifier: NCT01031784
[2] Study results have been published in PhD thesis of J.F. Prince; ISBN 978-90-393-6489-5; 2016.
ClinicalTrials.gov Identifier: NCT01612325