Company

Pioneering ECP Immunomodulation for over 35 years

Therakos specialises in photopheresis technology and has been providing ECP (Extracorporeal Photopheresis) solutions for over 35 years.

The THERAKOS™ CELLEX™ Photopheresis System has received CE Certification under the European Union Medical Device Regulation (EU MDR).

EU MDR laws govern medical devices for safety and effectiveness, and the CE Certification for THERAKOS is a significant milestone, marking the achievement of compliance with the latest rigorous European Union medical device standards. The EU MDR label includes the following EU approved indications:

The THERAKOS™ CELLEX™ Photopheresis System is indicated for patients older than 18 years of age for the administration of photopheresis in the following:

Cutaneous T Cell Lymphoma (CTCL)
Solid Organ Transplant Rejection (SOT) (heart, lung)

The THERAKOS™ CELLEX™ Photopheresis System is indicated in patients older than 3 years of age for the management of:

Acute and Chronic Graft versus Host Disease (aGvHD, cGvHD)

For over 30 years, we have played a pioneering role in advancing the science of immunotherapy delivered through ECP. We continue to invest in the highest standards of medical education, while seeking to refine our technologies, and remaining dedicated to furthering advances in ECP Immunomodulation.

Our THERAKOS^TM CELLEX^TM Photopheresis System is the only fully integrated and validated system for the delivery of ECP.¹

We strive to provide innovative therapeutic platforms and comprehensive support services to help healthcare professionals deliver optimised ECP Immunomodulation to patients.

We are dedicated to helping improve patients’ lives. That’s why we offer a comprehensive range of support services to healthcare professionals to help them feel more confident in delivering ECP Immunomodulation to their patients.

Dedicated to the practice and technological advancement of ECP for over 30 years

In 1987, we pioneered ECP treatment with the launch of our unique and innovative THERAKOS^TMUVAR XTS^TMSystem, which gained FDA approval the following year. Since then, we have been the only providers of fully integrated and validated ECP systems.

Our current platform, the THERAKOS^TM CELLEX^TM Photopheresis System, first arrived in 2009. It has since been used to deliver over 1.3 million treatments and is used in over 300 treatment centres across 30 countries²

Technological advancements from 1987 to today

The evolution of our integrated ECP
Immunomodulation platforms

Our Offer

Beyond the THERAKOS^TMCELLEX^TM Photopheresis System, we offer a range of support services to help enable healthcare professionals deliver optimised ECP Immunomodulation to patients.

Education And Knowledge Sharing

Our education and knowledge sharing, delivered through the Therakos Institute, is a valuable tool to healthcare professionals. It provides high-quality professional education provided by leading clinicians, scientific advisors and nurse trainers.

Patient and Funding Access

We offer patient and funding access support through a number of different initiatives. This helps us to advance the knowledge and clinical practice of ECP Immunomodulation for future generations.

Patient shaking hands with clinician icon

Scientific and Clinical Partnerships

Through our scientific and clinical partnerships, we strive to maintain the highest possible standards – uniting with leading figures across the world to ensure we provide the strongest possible service.

Comprehensive Customer Support

A key part of our service is providing comprehensive customer support. Our aim is to help front-line users feel confident in delivering ECP Immunomodulation treatment to patients.

ECP, extracorporeal photopheresis; FDA, Food and Drug Administration.

References:

1.Knobler R, et al. J Eur Acad Dermatol Venereol. 2020;34(12):2693-2716.2.Therakos (UK) Ltd. Data on File – ref-05174.

IMPORTANT SAFETY INFORMATION FOR THE THERAKOS™ PHOTOPHERESIS PROCEDURE

Indications

The THERAKOS™ CELLEX™ Photopheresis System is indicated for patients older than 18 years of age for the administration of photopheresis in the following:

Cutaneous T Cell Lymphoma (CTCL)
Solid Organ Transplant Rejection (SOT) (heart, lung)

The THERAKOS™ CELLEX™ Photopheresis System is indicated in patients older than 3 years of age for the management of:

Acute and Chronic Graft versus Host Disease (aGvHD, cGvHD)

Contraindications

THERAKOS^TM Photopheresis is contraindicated in:

Patients possessing a specific history of a light sensitive disease
Patients who cannot tolerate extracorporeal volume loss or who have white blood cell counts greater than 25,000 / mm³
Patients who have coagulation disorders or who have previously had a splenectomy

Warnings and Precautions

THERAKOS^TMPhotopheresis treatments should always be performed in locations where standard medical emergency equipment is available. Volume replacement fluids and/or volume expanders should be readily available throughout the procedure.

Do not expose the device to a magnetic resonance (MR) environment. The device may present a risk of projectile injury, and thermal injury and burns may occur. The device may generate artifacts in the MR image, or may not function properly.
Thromboembolic events, including pulmonary embolism and deep vein thrombosis, have been reported in the treatment of Graft versus Host Disease (GvHD). Special attention to adequate anticoagulation is advised when treating patients with GvHD.
When prescribing and administering THERAKOS Photopheresis for patients receiving concomitant therapy, exercise caution when changing treatment schedules to avoid increased disease activity that may be caused by abrupt withdrawal of previous therapy.

Adverse Events

Hypotension may occur during any treatment involving extracorporeal circulation. Closely monitor the patient during the entire treatment for hypotension.
Transient pyretic reactions, 37.7–38.9°C (100–102°F), have been observed in some patients within six to eight hours of reinfusion of the photoactivated leukocyte-enriched blood. A temporary increase in erythroderma may accompany the pyretic reaction.
Treatment frequency exceeding labelling recommendations may result in anaemia.
Venous access carries a small risk of infection and pain.

IMPORTANT SAFETY INFORMATION FOR METHOXSALEN USED IN CONJUNCTION WITH THERAKOS^TM PHOTOPHERESIS

Consult the 8-methoxypsoralen (Methoxsalen (20 micrograms / mL)) professional leaflet or the oral 8-methoxypsoralen formulation package insert before prescribing or dispensing any medication.

Warnings and Precautions

Patients exhibiting multiple basal cell carcinomas or having a history of basal cell carcinoma should be diligently observed and treated.
Methoxsalen may cause fetal harm when given to a pregnant woman. Women undergoing photopheresis should be advised to avoid becoming pregnant.
Special care should be exercised in treating patients who are receiving concomitant therapy (either topically or systemically) with known photosensitizing agents.
Oral administration of methoxsalen followed by cutaneous UVA exposure (PUVA therapy) is carcinogenic.
Patients should be told emphatically to wear UVA absorbing, wrap-around sunglasses for twenty-four (24) hours after methoxsalen treatment. They should wear these glasses any time they are exposed to direct or indirect sunlight, whether they are outdoors or exposed through a window.

Refer to the package insert for methoxsalen sterile solution (20 micrograms / mL) or the oral 8-methoxypsoralen dosage formulation for a list of all warnings and precautions.

Company

Pioneering ECP Immunomodulation for over 35 years

The THERAKOS™ CELLEX™ Photopheresis System has received CE Certification under the European Union Medical Device Regulation (EU MDR).

EU MDR laws govern medical devices for safety and effectiveness, and the CE Certification for THERAKOS is a significant milestone, marking the achievement of compliance with the latest rigorous European Union medical device standards. The EU MDR label includes the following EU approved indications:

Dedicated to the practice and technological advancement of ECP for over 30 years

Technological advancements from 1987 to today

Our Offer

Education And Knowledge Sharing

Patient and Funding Access

Scientific and Clinical Partnerships

Comprehensive Customer Support

Discover more

THERAKOS™ CELLEX™ Photopheresis System

THERAKOS ECP Immunomodulation™

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IMPORTANT SAFETY INFORMATION FOR THE THERAKOS™ PHOTOPHERESIS PROCEDURE

IMPORTANT SAFETY INFORMATION FOR METHOXSALEN USED IN CONJUNCTION WITH THERAKOSTM PHOTOPHERESIS

IMPORTANT SAFETY INFORMATION FOR METHOXSALEN USED IN CONJUNCTION WITH THERAKOS^TM PHOTOPHERESIS