Terumo's BioPearl, the First Biodegradable Drug Eluting Microspheres Received CE mark

LEUVEN, BELGIUM - April 28, 2020 - Terumo Europe N.V. today announced that BioPearl™ Microspheres received CE Mark, making it an innovative new option for patients eligible for loco-regional embolization of target artery blood supply to liver cancer. BioPearl™ Microspheres, the next generation of drug eluting microspheres, are designed to preserve post-TACE target artery access, opening up the potential for cyclic treatment^1,2.

"The availability of BioPearl™ Microspheres is an important milestone in Interventional Oncology as it is the first biodegradable drug-eluting microsphere loadable with 3 chemotherapeutic drugs (doxorubicin, idarubicin and epirubicin). BioPearl™ may further improve patient outcomes by enabling retreatment of the same target artery." said Peter Coenen, President of Interventional Systems Terumo EMEA. "BioPearl™ Microspheres are leading the way to new opportunities with a biodegradable (TACE) by allowing future treatment options to be kept open. BioPearl™ Microspheres represent Terumo's latest innovation complementing our loco-regional treatment portfolio."

Currently, Drug-Eluting Microsphere TACE (DEM-TACE) and conventional-TACE are both used worldwide. BioPearl™ Microspheres have been designed based upon clinicians' desire to have controlled drug elution while keeping future treatment options open. BioPearl™ Microspheres could change treatment algorithms and may offer more choices for patients.

"Interventional Oncology is not a stand-alone speciality and by working with medical oncologists, we will be able to optimize current and future treatments, namely by delivering drugs directly into the tumour. Through such collaboration, we may be able to reduce the dosage and improve the toxicity profile of anticancer drugs and ultimately improve the field." said Pr. Thierry De Baere from Institute Gustave Roussy in Villejuif - France. "BioPearl™ drug eluting Microspheres and its degradation profile is a significant next step toward enhancing localized drug delivery and hopefully improving patient outcomes."

¹ Data on file - TR18-174B. BioPearl™ liver studies

² Data on file -TR18 - 174C. BioPearl™ liver studies

About Terumo Europe

Terumo Europe is a core player in the EMEA healthcare market by providing best in class quality medical products and services. We are a strong actor of the Terumo Group by contributing to innovation and sustainable growth. Terumo Europe produces, distributes, markets and sells a vast range of medical devices in five main business units: Interventional Systems, Pharmaceutical Solutions, Medical Products, Cardiovascular Products and Diabetes Management. Terumo Europe EMEA headquarters and production facilities are located in Leuven (Belgium), production facility in Knowsley (UK), European Distribution Center in Genk (Belgium) and sales offices across EMEA. www.terumo-europe.com

Disclaimer

INTENDED USE/INDICATIONS:

• ■ BioPearl™ Microspheres are indicated for embolization of blood vessels supplying primary-hypervascular tumors or metastases in the liver.
• ■ Note: BioPearl™ Microspheres can be loaded with chemotherapeutic drugs. When used for drug loading, drug loading should be done under a physician's direction, choice and responsibility, based on type and dose of drug most beneficial to the patient.
• ■ The BioPearl™ Microspheres are compatible with Doxorubicin, Epirubicin, and Idarubicin, which can be loaded prior to embolization and then, as a secondary action, elute a local, controlled, and sustained dose to the tumor after embolization.
• ■ BioPearl™ Microspheres are indicated for embolization according to the IFU. They may be loaded with a drug to elute a local, controlled, sustained dose of said drug to targeted tumor sites after embolization. Loading of drug should be under a physician's direction, choice and responsibility, based on type and dose of drug most beneficial to the patient.
  
  BioPearl™ Microspheres are not available for sale in all countries.