Therakos secures EU MDR approval for Cellex photopheresis system
Medical device firm Therakos received EU Medical Device Regulation approval for its THERAKOS CELLEX Photopheresis System to treat steroid refractory immune adverse events
Therakos Development Limited, a global leader in immunomodulatory therapy via extracorporeal photopheresis, has secured EU MDR approval for its THERAKOS™ CELLEX™ Photopheresis System. The newly certified system is now indicated for treating immune-related adverse events (irAEs) associated with immune checkpoint inhibitor (ICI) therapy in adults who have not responded adequately to corticosteroids.
This marks the first and only therapy approved for this use in Europe, offering a significant advancement in managing steroid-refractory irAEs. The system uses the patient's own cells to address toxicity without broad immunosuppression, preserving the benefits of cancer immunotherapy. The THERAKOS™ CELLEX™ Photopheresis System is available at over 190 centers across Europe for treatment of irAEs in ICI therapy patients who have had an inadequate response to corticosteroids.
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