Fresenius Kabi Launches Single-Needle Option for the Amicus® Extracorporeal Photopheresis Protocol
Fresenius Kabi today announced the availability of a single-needle venous access option for the Amicus® Extracorporeal Photopheresis (ECP) System at the 49th annual meeting of the European Society for Blood and Marrow Transplantation (EBMT).
Fresenius Kabi is a global health care company that specializes in medicines and technologies for infusion, transfusion and clinical nutrition.
The Amicus Blue System with online ECP was launched in Europe in 2019 with double-needle venous access only. The update announced today includes new software v6.1 for the Amicus Separator, new software v2.1 for the Phelix Photoactivation Device and a new single-use disposable kit that can be configured for single or double-needle venous access. The system also allows clinicians to switch between single and double-needle access at any time during the procedure.
“We are thrilled to enable the single-needle option for the Amicus Blue ECP system, which will allow physicians to treat patients with limited venous access. This builds on our Amicus Blue vision to provide a versatile, multi-procedural instrument to support patients’ individual needs,” said Christian Hauer, President Fresenius Kabi MedTech.
The Amicus ECP System has obtained CE mark for the indication of CTCL in the palliative treatment of the skin manifestations of cutaneous T-cell lymphoma (CTCL) that is unresponsive to other forms of treatment. The Amicus ECP System is CE marked in compliance with the applicable requirements of the Medical Device Regulation (EU) 2017/745 and includes:
- Amicus Separator
- Phelix Photoactivation Device
- Amicus ECP Apheresis Kits
Amicus Separator is also cleared in Europe and the United States for therapeutic plasma exchange (TPE), red blood cell exchange (RBCx), mononuclear cell (MNC) collection and platelet collection. The Amicus ECP System is not cleared for use in the U.S.
Not all products listed are available or approved for sale in all countries. Contact your local Fresenius Kabi representative for additional information and product availability. Refer to the Amicus Separator Operator’s Manual and Phelix Photoactivation Device Operator’s Manual for a complete list of warnings and precautions associated with the use of these products.
About Extracorporeal Photopheresis
Extracorporeal photopheresis or ECP is a leukapheresis-based therapeutic procedure. The technology is currently approved for the treatment of cutaneous T-cell lymphoma (CTCL). Literature shows that it has also been used for graft versus host disease (GvHD) following bone marrow or stem cell transplant, the rejection of solid organ transplants, and autoimmune diseases where cell-mediated mechanisms are dominant.
An online ECP procedure involves collection of mononuclear cells from the patient, treatment of collected cells with a light sensitive drug, 8-methoxypsoralen and exposure of cells to UV-A light, followed by the reinfusion of treated cells back to the patient. After reinfusion, the treated cells become apoptotic and are believed to be taken up by antigen presenting cells resulting in an immune response. The online ECP process combines cell separation and photoactivation into a single, sterile circuit reducing the risk of infection and cross-contamination.
About Cutaneous T-cell Lymphoma
Cutaneous T-cell lymphomas are a heterogenous group of T-cell lymphoproliferative disorders involving the skin, the most common variants classified as Mycosis Fungoides (MF) or Sézary Syndrome (SS). Patients may experience itchy, scaly patches or plaques of the skin. As the disease progresses, some patients may experience growth of nodular lesions and large tumors, and internal organ involvement. Treatment is palliative, with the aim to induce long-term remissions and improve patient quality of life.
About Fresenius Kabi
Fresenius Kabi (www.fresenius-kabi.com) is a global health care company that specializes in medicines and technologies for infusion, transfusion and clinical nutrition. The company’s products and services are used to help care for critically and chronically ill patients. The company’s global headquarters is in Bad Homburg, Germany.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20230423005002/en/
Contact information
Dolores Juarez
+49 152 563 86727
dolores.juarez@fresenius-kabi.com
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Ant Group Unveils China’s First Multimodal AI Assistant with Code-Driven Outputs18.11.2025 10:05:00 EET | Press release
Ant Group today launched LingGuang, a next-generation multimodal AI assistant and the first of its kind in China that interacts with users through code-driven outputs. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251117438567/en/ Equipped with the capability to understand and produce language, image, voice and data, LingGuang delivers precise, structured responses to complex queries through 3D models, audio clips, charts, animations, interactive maps, and even immediately generated applications, in addition to traditional text-based conversation. Designed around three key features, LingGuang aims to make complex knowledge simpler and more intuitive, transforming how users access information and interact with AI tools. Fast Research: LingGuang responds to user questions or keywords with dynamic, multimodal content, making research on any topic clearer and more engaging. Its 3D digital modeling capability transcends traditio
SkySparc Appoints Oliver Bussmann as Chairman of the Board18.11.2025 10:00:00 EET | Press release
SkySparc, a trusted global provider of digital transformation solutions for treasury and finance organizations, today announced the appointment of Oliver Bussmann as Chairman of the Board, following the closing of a majority growth investment from Bregal Milestone, a leading European software private equity firm. As former Global CIO at UBS and SAP, Bussmann has a proven track record of scaling B2B software and services across the Office of the CFO, Financial Services, RegTech, and WealthTech. Throughout his career, he has guided organizations through complex SaaS transitions, strategic M&A, and go-to-market acceleration – delivering multiple successful exits and sustained enterprise growth. Bussmann will help steer SkySparc’s technology and value-creation agenda, as Chairman, leveraging his network across financial services and technology to accelerate innovation, expand AI adoption, and drive long-term growth. “We are thrilled to welcome Oliver to SkySparc’s leadership team,” said Jo
European Commission Grants Approval of Remsima™ IV Liquid Formulation, World’s First Liquid Formulation of IV Infliximab18.11.2025 09:23:00 EET | Press release
Celltrion, Inc. today announced that the European Commission (EC) has granted marketing authorization for Remsima™ IV (intravenous) liquid formulation, the world’s first liquid formulation of IV infliximab. Approved in 100 mg and 350 mg vials, the formulation is designed to streamline infusion preparation, reduce healthcare professionals’ workload, and support hospital operational efficiency.3 The Remsima™ IV liquid formulation is approved in the EU for all indications of IV infliximab, matching the approved uses of all existing IV infliximab powder formulations, including rheumatoid arthritis (RA), adult and pediatric Crohn’s disease (CD), ulcerative colitis (UC), pediatric UC, ankylosing spondylitis (AS), psoriatic arthritis (PsA), and psoriasis (PsO).1 The comparability between lyophilized powder formulation and the liquid formulation of IV infliximab has been established through comprehensive chemistry, manufacturing, and controls data.2 The stability of the liquid formulation of I
Swiss-Based Debiopharm Seeks to Boost Innovation in Japanese Cancer Research Through the New "Ideal Japan” Program18.11.2025 09:00:00 EET | Press release
Debiopharm (www.debiopharm.com), a Swiss biopharmaceutical company aiming to cure cancer and infectious diseases, is pleased to announce today the launch of the new IDEAL Japan initiative. This program was initiated to provide financial support to Japanese academic researchers in order to facilitate the transformation of academic innovation into novel therapeutic approaches for combating cancer. IDEAL Japan follows the conclusion of the highly respected JCA (Japanese Cancer Association) Mauvernay Award in Japan, which honored Japanese scientists over the last 20 years, from 2004 through 2024. Debiopharm is now transitioning its historic award into the IDEAL Japan initiative aiming to accelerate preclinical scientific research that could give rise to new treatments for cancer patients. “Our vision is to collaborate to find a cure for cancer,”explained Thierry Mauvernay, President of Debiopharm. “We believe that our ongoing Swiss-Japanese connection needs to evolve and catalyze the trans
Avanzanite Bioscience Secures €32M Series A Investment from MVM Partners18.11.2025 08:00:00 EET | Press release
Avanzanite Bioscience B.V. (Avanzanite), a rapidly growing commercial-stage European specialty pharmaceutical company focused on rare diseases, today announced a €32 million Series A growth investment from MVM Partners (MVM), a leading global life-science private equity firm. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251117345890/en/ Adam Plich, Founder and CEO of Avanzanite. The announcement follows a record-breaking Q3 2025 for Avanzanite, with revenue tripling year-on-year and climbing over 20% quarter-on-quarter. This strategic funding will accelerate the expansion of Avanzanite’s pan-European infrastructure and propel both current and future rare disease product launches. The capital will also enable Avanzanite to form new strategic alliances and acquire assets to expand its portfolio. Avanzanite was built to solve Europe’s rare-disease medicines access gap. Under one pan-European operation, Avanzanite brings toget
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom