Terumo Europe N.V. announces the launch of the BIOPEARL-ONE study, a new multi-center post market clinical trial: BioPearl™ microspheres are loaded with doxorubicin to treat patients with unresectable hepatocellular carcinoma (HCC). A prospective, single arm, multi-centre post-market follow-up study is intended to assess the safety and efficacy of BioPearl™ microspheres loaded with doxorubicin in the treatment of patients with unresectable HCC.

TACE is the guideline-recommended, first line treatment of patients with intermediate-stage HCC¹⁻⁶ and DEM-TACE provides a standardized treatment approach¹,²,⁷. However, with well-established TACE techniques, signs of liver injury and hepatic insufficiency are the most common adverse effects⁸ while liver function must be preserved to safely perform potential follow up surgery, systemic or intra-arterial locoregional treatments⁹.

BioPearl Microspheres are the first resorbable drug-eluting microspheres designed to allow progressive blood flow restoration and lesion intra-arterial access, offering more opportunities for future treatments¹⁰,¹¹. BioPearl microspheres bring the confidence of the embolic effect and sustained drug release from the drug-loadable Microspheres technology¹¹.

In the BIOPEARL-ONE study, patients will be enrolled in six European centers with the aim of generating post-market clinical evidence on the potential benefits of resorbable drug-eluting microspheres.

Prof Roberto Iezzi from Fondazione Policlinico Gemelli IRCCS, Catholic University, in Rome, coordinating investigator, said: “BioPearl Microspheres and its degradation profile brings a new concept to the TACE therapy and will hopefully allow for improved follow-up treatment outcomes thanks to the expected vessel flow restoration. BIOPEARL-ONE study will give us greater insights on this new technology’s clinical outcomes.”

Ghada Farah, Senior Vice President TIS EMEA, said: “I’m really excited about the launch of the BIOPEARL-ONE study. It is a major milestone to make BioPearl Microspheres, Terumo’s latest innovation in TACE treatment, available to TACE eligible patients – enabling healthcare providers to open new horizons in treating HCC.”

Enrollment is expected to be completed by May 2026, and results should be available early January 2028.
ClinicalTrials.gov reference: NCT05911633

For more information

Name: Olivier Sophie
Title: Marketing Manager Interventional Oncology EMEA
Sophie.olivier@terumo-europe.com

About Terumo Europe

Terumo Europe N.V. is a core player in the EMEA healthcare market by providing best-in-class quality medical products and services. Terumo Europe is 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, Hospital Care Solutions, Cardiovascular and Life Care Solutions. Terumo Europe EMEA headquarters and production facilities are located in Leuven (Belgium), European Distribution Center in Genk (Belgium) and sales offices across EMEA.

About Terumo Corporation

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 30,000 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.

Diclaimer

Intended Purpose: BioPearl™ microspheres are indicated for embolization of blood vessels supplying primary-hypervascular tumours 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. BioPearl™ microspheres are compatible with doxorubicin, epirubicin, and idarubicin. BioPearl™ microspheres can be drug loaded prior to embolization and then, as a secondary action, elute a local, controlled, and sustained dose to the targeted tumour sites after embolization. BioPearl™ microspheres are not available for sale in all countries.

This information is provided only in respect to markets where this product is approved or cleared. The use of the BioPearl™ devices is not cleared or approved in the USA by the Food and Drug Administration. BioPearl™ microspheres are not approved in Canada. Please contact your Terumo local sales representative for more information. BioPearl™ microspheres are manufactured by MicroVention and exclusively distributed by Terumo Europe NV in EMEA region. All brand names are trademarks or registered trademarks of TERUMO CORPORATION and their respective owners. Refer to Instructions for Use for Contraindications, Warnings and Precautions.

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