Terumo Blood and Cell Technologies, the medical technology company specializing in a portfolio of products, software and services for blood collection, therapeutic apheresis and cellular technologies, today announces a direct offering for physicians to perform extracorporeal photopheresis immunotherapy (ECP) procedures at the patient's bedside.
The company has expanded the functionality of Spectra Optia, its industry-leading therapeutic apheresis, cell processing and cell collection platform, with an accessory device, the UVA PIT System.1 ECP can now be performed using these devices together as a functionally closed, online, multistep system with mononuclear cell collection (MNC) and continuous mononuclear cell collection (CMNC) protocols.
"Terumo Blood and Cell Technologies invests about three times more than the medical device industry average in innovation. This includes technology advances, expanded geographic impact and strategic relationships. These investments enable us to bring additional novel solutions to increase therapeutic options for more patient populations. Our investment with PIT Medical Systems increases the functionality of our existing therapeutic apheresis technology and reinforces our commitment to serve more patients." -Antoinette Gawin, President and Chief Executive Officer, Terumo Blood and Cell Technologies.
How it works
Spectra Optia from Terumo Blood and Cell Technologies is a therapeutic apheresis, cell processing and cell collection platform. The UVA PIT System delivers automated photoactivation of white blood cells using ultraviolet light which, in association with an adjunct psoralen derivative, shuts down genes that sustain the life of specific blood cells, ultimately leading to the modulation of patients' immune responses to a wide variety of diseases. The procedure includes creating sterile tubing connections between the two systems and from the connected systems to the patient infusion line. The patient remains connected to Spectra Optia throughout the whole procedure.
Because the system provides a functionally closed, multistep procedure enabling treatment at the bedside, hospitals have an additional way to perform ECP procedures that offers low risk of cross-contamination, infection and infusion errors.
Under some conditions, Spectra Optia's MNC and CMNC protocols can accommodate low-body-weight patients by offering lower extracorporeal volume (ECV) of blood.
"PIT Medical Systems has global expertise and experience in photopheresis technology and is committed to increasing access to patients," said Waldfried Weber, Chief Executive Officer of PIT Medical Systems. "By partnering with Terumo Blood and Cell Technologies, we combine our proven photo-immune device with an industry-leading therapeutic apheresis system and an expansive global footprint. This will deliver a novel solution to more hospitals to treat more patients."
The therapy and products are available in select European, Middle East and African countries.
- Procedure availability, including availability of the MNC or CMNC procedure using the Spectra Optia system for performing extracorporeal photopheresis with the UVA PIT system, varies by region and by country. The UVA PIT System and UVA PIT KIT are not cleared for sale in the U.S.
- - The UVA PIT system is manufactured by PIT Medical Systems GmbH. The UVA PIT KIT is manufactured by HMC Premedical S. P. A. Available in select markets.
About extracorporeal photopheresis (ECP)
Extracorporeal photopheresis, or photopheresis, is a non-surgical medical treatment in which the patient's blood is collected from a vein on the arm or a permanent catheter and further processed outside the body. The blood is processed by centrifugation in an apheresis device that is specially manufactured for this procedure to separate the white blood cells from the red blood cells and plasma. The white blood cells are then treated with a photoactive compound called 8-methoxypsoralen, exposed to ultraviolet A (UVA) light in a separate chamber, then reinfused to the patient along with the rest of the blood components.
Since the first clinical application of ECP for the treatment of Sézary syndrome, the leukemic form of cutaneous T-cell lymphoma (CTCL), in 1987,2 indications for initiating ECP have been continuously extended over the past decades. According to most recent guidelines, ECP is recommended as a first-line therapy for the treatment of CTCL's erythrodermic forms of mycosis fungoides as well as Sézary syndrome and as a second-line therapy for steroid-resistant acute and chronic graft-versus-host disease (GvHD), cardiac transplant rejection and bronchiolitis obliterans syndrome following lung transplantation.3-8
Early studies ascribed the therapeutic effect of ECP to the initiation of apoptosis in lymphoid cells, but recent research has shown that the therapeutic effect of ECP is primarily due to modulations of the patients' immune system upon reinfusion of treated cells.9-11 Although distinct aspects of ECP's mode of action are well understood today,12,13 research is still ongoing toward understanding its efficacy in such a wide variety of settings.14
1PIT Medical Systems GmbH manufactures the UVA PIT System.
2Edelson R, Berger C, Gasparro F, et al. Treatment of cutaneous T-cell lymphoma by extracorporeal photochemotherapy. N Engl J Med. 1987;316(6):297-303. doi: 10.1056/NEJM198702053160603
3Padmanabhan A, Connelly-Smith L, Aqui N, et al. Guidelines on the use of therapeutic apheresis in clinical practice - evidence-based approach from the writing committee of the American Society for Apheresis: the eighth special issue. J Clin Apher. 2019;34(3):171-354. doi: 10.1002/jca.21705
4Knobler R, Arenberger P, Arun A, et al. European dermatology forum: updated guidelines on the use of extracorporeal photopheresis 2020 - part 2. J Eur Acad Dermatology Venereol. 2021;35(1):27-49. doi: 10.1111/jdv.16889
5Knobler R, Arenberger P, Arun A, et al. European dermatology forum - updated guidelines on the use of extracorporeal photopheresis 2020 - part 1. J Eur Acad Dermatology Venereol. 2020;34(12):2693-2716. doi: 10.1111/jdv.16890
6Worel N, Mansouri Taleghani B, Strasser E. Recommendations for therapeutic apheresis by the aection "preparative and therapeutic hemapheresis" of the German Society for Transfusion Medicine and Immunohematology. Transfus Med Hemother. 2019;46(6):394-406. doi: 10.1159/000503937
7Alfred A, Taylor PC, Dignan F, et al. The role of extracorporeal photopheresis in the management of cutaneous T-cell lymphoma, graft-versus-host disease and organ transplant rejection: a consensus statement update from the UK Photopheresis Society. Br J Haematol. 2017;177(2):287-310. doi: 10.1111/bjh.14537
8Pierelli L, Perseghin P, Marchetti M, et al. Extracorporeal photopheresis for the treatment of acute and chronic graft-versus-host disease in adults and children: best practice recommendations from an Italian Society of Hemapheresis and Cell Manipulation (SidEM) and Italian Group for Bone Marrow Transplantation (GITMO) consensus process. Transfusion. 2013;53(10):2340-2352. doi: 10.1111/trf.12059
9Goussetis E, Varela I, Tsirigotis P. Update on the mechanism of action and on clinical efficacy of extracorporeal photopheresis in the treatment of acute and chronic graft versus host disease in children. Transfus Apher Sci. 2012;46(2):203-209. doi: 10.1016/j.transci.2011.10.017
10Wolnicka-Glubisz A, Fraczek J, Skrzeczynska-Moncznik J, et al. Effect of UVA and 8-methoxypsoralen, 4, 6, 4'-trimethylangelicin or chlorpromazine on apoptosis of lymphocytes and their recognition by monocytes. J Physiol Pharmacol. 2010;61(1):107-114. http://www.ncbi.nlm.nih.gov/pubmed/20228422
11Cho A, Jantschitsch C, Knobler R. Extracorporeal photopheresis--an overview. Front Med. 2018;5:236. doi: 10.3389/fmed.2018.00236
12Han P, Hanlon D, Arshad N, et al. Platelet P-selectin initiates cross-presentation and dendritic cell differentiation in blood monocytes. Sci Adv. 2020;6(11). doi: 10.1126/sciadv.aaz1580
13Edelson RL. Mechanistic insights into extracorporeal photochemotherapy: efficient induction of monocyte-to-dendritic cell maturation. Transfus Apher Sci. 2014;50(3):322-329. doi: 10.1016/j.transci.2013.07.031
14Edelson R, Wu Y, Schneiderman J. American council on ECP (ACE): why now? J Clin Apher. 2018;33(4):464-468. doi: 10.1002/jca.21627
About Terumo Blood and Cell Technologies
Terumo Blood and Cell Technologies is a medical technology company. We have a portfolio of products, software and services for blood collection, therapeutic apheresis and cellular technologies enabling customers to collect and prepare blood and cells to help treat challenging diseases and conditions. Our employees around the world believe in the potential of blood and cells to do even more for patients than they do today.
Terumo Blood and Cell Technologies' customers include blood centers, hospitals, therapeutic apheresis clinics, cell collection and processing organizations, researchers and private medical practices. Our customers are based in over 130 countries across the globe. The company works to improve patient outcomes by providing innovations that address unmet medical needs.
The company has over 750 granted patents, with more than 150 additionally pending.
Headquartered in Lakewood, Colorado, U.S., the company has five regional headquarters, six manufacturing sites and six innovation and development centers across the globe. It employs nearly 7,000 associates.
Terumo Blood and Cell Technologies is a subsidiary of Terumo Corporation (TSE: 4543), a global leader in medical technology. TERUMOBCT.COM
About PIT Medical Systems
PIT Medical Systems with its UVA PIT System is one of the world's leading manufacturers of an extracorporeal photopheresis (ECP) system. The UVA PIT System provides a complete solution for the two-step ECP technique.
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.