Fresenius Kabi Launches Single-Needle Option for the Amicus® Extracorporeal Photopheresis Protocol
23.4.2023 10:00:00 EEST | Business Wire | Press release
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
TIME Names Xenco Medical one of the TIME100 Most Influential Companies in the World and the Winner of the 2026 TIME100 Impact Award in Health1.5.2026 13:07:00 EEST | Press release
Time Magazine has named pioneering medical technology company Xenco Medical as one of the TIME100 Most Influential Companies in the World and the Winner of the 2026 TIME100 Impact Award in Health. Widely regarded as the most prestigious recognition in business and technology, being selected to the TIME100 List remains the most coveted accolade that a company can achieve globally. The TIME100 Impact Awards are given to only 5 recipients each year, making it the rarest of honors that a company can receive and a profound recognition of transformative, global impact. Xenco Medical was honored by Time as the sole recipient of the TIME100 Impact Award in Health in 2026, signifying its leading, global distinction in impact on healthcare. According to Time Magazine, the TIME100 Most Influential Companies list highlights “companies making an extraordinary impact around the world.” The honor bestowed by Time comes after Xenco Medical was named the 2025 Medical Device/ Diagnostics Company of the
Inspirit Capital Completes Acquisition of Kaplan Languages Group1.5.2026 02:17:00 EEST | Press release
Inspirit Capital, a specialist investor in corporate carve-outs, and Kaplan, the global education company, have announced the completion of Inspirit’s acquisition of Kaplan Languages Group (KLG) from Kaplan. Financial terms are not being disclosed. KLG, a leading global language education platform, comprises Kaplan International Languages, Alpadia Language Schools, Azurlingua, and ESL Education. Inspirit Capital will support KLG in delivering on its ambitious growth plans, whilst continuing its fundamental mission to transform lives through language education. The next phase of ownership will see the development and launch of a refreshed standalone brand identity for KLG, with further announcements to follow on this in due course. KLG will continue to use the Kaplan name under a transitional license from Kaplan, Inc. until a new brand is announced. About Kaplan Languages Group Since 2006, KLG has provided the highest quality language education and cultural immersion experiences. Kaplan
Grindr Nominates Three New Directors to Its Board of Directors1.5.2026 00:16:00 EEST | Press release
Grindr Inc. (NYSE: GRND), the Global Gayborhood in Your Pocket™, today announced the nomination of Rob Solomon, Lisa Gersh, and Fadi Hanna to stand for election to its Board of Directors at the Annual Meeting of Shareholders on June 2, 2026. Rob Solomon is a deeply seasoned technology CEO and operator in consumer internet and marketplaces. He has held CEO and COO roles at scaled platforms including GoFundMe, Groupon, and Kayak-predecessor SideStep, and is currently CEO of leading electric aviation company H55. Lisa Gersh is a CEO and long-tenured public company director with deep experience across consumer brands, media, and commerce. She has served on the Hasbro (NASDAQ: HAS) board since 2010 and has led businesses including Oxygen Media, GOOP, and Alexander Wang. Fadi Hanna is Chief Risk Officer at Bloomberg L.P., overseeing enterprise risk across the organization. He previously worked at J.P. Morgan and has served on the board of Immigration Equality. “Over the last few years, we bu
The Empire State Building Celebrates 95 Years as the ‘World’s Most Famous Building’30.4.2026 23:42:00 EEST | Press release
The Empire State Building (ESB), the “World’s Most Famous Building,” will celebrate its 95th anniversary on May 1, 2026, with new offers at the Empire State Building Observation Deck, a special birthday tower lighting display, and a slate of celebrations to honor its legacy and future. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260430693323/en/ The Empire State Building Celebrates 95 Years as the ‘World’s Most Famous Building’ “The Empire State Building celebrates its 95th anniversary, still the ‘World’s Most Famous Building,’ a modernized, sustainability leader as technologically advanced today as the day she was completed, and the winner of #1 Top Attraction in the United States in Tripadvisor’s Travelers’ Choice Awards for 2026,” said Anthony E. Malkin, chairman and CEO of Empire State Realty Trust. Anniversary Offerings and Experiences To mark its 95th anniversary, the Empire State Building will debut new experiences
MRM Health’s Lead Candidate MH002 Granted Fast Track Designation by U.S. FDA for the Treatment of Mild-to-Moderate Ulcerative Colitis30.4.2026 23:17:00 EEST | Press release
MRM Health, a clinical-stage biopharmaceutical company developing therapeutics for immune-mediated diseases, which unlock the power of the microbiome to restore immune balance, today announced that MH002, the Company’s lead rationally designed Live Biotherapeutic Product (LBP) candidate, has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of mild-to-moderate ulcerative colitis (UC). MH002 today is the most advanced LBP targeting inflammatory bowel disease (IBD)-specific mechanisms and is composed of a rationally designed microbial consortium of six well-characterized commensal strains. The FDA’s Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important drugs to patients earlier. Fast Track designation enables frequent communication with the FDA to discuss the drug's development plan and ensure collection o
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