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January 19, 2018

Leuven, Belgium - January 19, 2018 - Terumo Europe N.V, announces the approval of LifePearl Microspheres as a Class III device in Europe. This approval also expands the loadable chemotherapeutic drugs to include Idarubicin and Epirubicin.

LifePearl® class III device is used in the treatment of primary and secondary liver cancer and it comprises a range of microspheres that are biocompatible, hydrophilic, precisely calibrated and capable of loading and releasing chemotherapeutic agents in a controlled manner.

Since its launch in 2015, LifePearl® microspheres have been used in approximately 8,000 TACE procedures in Europe, Middle East and Africa. LifePearl has five publications in various scientific journals and multiple presentations in Interventional radiology congresses.

A recent study demonstrated that amongst 11 anticancer drugs used in trans-arterial chemoembolization, Idarubicin is the best in vitro candidate drug for this treatment based on three HCC cell lines<sup> [1]</sup>. Due to its high lipophilicity, Idarubicin penetrates cell membranes more efficiently than other anthracycline compounds.

The recent approval to load additional chemotherapeutic agents into the LifePearl® device is providing more treatment options for interventional radiologists performing Drug-Eluting Microspheres TACE (DEM-TACE) procedures. The LifePearl® device are currently the only Drug-eluting-Microspheres CE Marked as a Class III device with capability of loading four chemotherapeutic agents: Doxorubicin, Idarubicin, Epirubicin and Irinotecan.

Prof Boris Guiu, from CHU Montpellier, France said: "Approved CE mark for LifePearl® loaded with Idarubicin is a first and important step towards an optimized regimen for TACE of HCC in daily practice. LifePearls® can load completely and fastly idarubicin, and provides prolonged release. This is of particular importance given the greater efficacy of Idarubicin on HCC cancer cell lines, as compared to other drugs including doxorubicin and Epirubicin".

  • [1]

    Screening of Anti-Cancer Drugs for chemo-embolization of hepatocellular carcinoma: Boulin M, et al., Anticancer Drugs 2011, 22:741-8

About Terumo

Terumo (TSE: 4543) is a global leader in medical technology and has been committed to “Contributing to Society through Healthcare” for 100 years. Based in Tokyo and operating globally, Terumo employs more than 28,000 associates worldwide to provide innovative medical solutions in more than 160 countries and regions. The company started as a Japanese thermometer manufacturer, and has been supporting healthcare ever since. Now, its extensive business portfolio ranges from vascular intervention and cardio-surgical solutions, blood transfusion and cell therapy technology, to medical products essential for daily clinical practice such as transfusion systems, diabetes care, and peritoneal dialysis treatments. Terumo will further strive to be of value to patients, medical professionals, and society at large.

Among the information that Terumo discloses, the forward-looking statements including financial projections are based upon our assumptions using information available to us at the time and are not intended to be guarantees of future events or performance. Accordingly, it should be noted that actual results may differ from those forecasts or projections due to various factors. Factors affecting to actual results include, but are not limited to, changes in economic conditions surrounding Terumo, fluctuations of foreign exchange rates, and state of competition.


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