The THERAKOS Photopheresis System

Five Good Reasons Why THERAKOS Is the Company of Choice for Photopheresis

(1) The THERAKOS Photopheresis System is FDA approved as a therapeutic medical device specifically for photopheresis.

The THERAKOS Photopheresis System has received FDA approval as a class III medical device, certifying the design, development, manufacture and maintenance of the THERAKOS Photopheresis System and its application to photopheresis.

FDA approval as a class III medical device includes standards for product design, functional safety, process validation, biocompatibility, sterility and pyrogenicity, and clinical efficacy as demonstrated by clinical trials.

(2) The THERAKOS Photopheresis System has a photoactivation module that is precisely monitored for its UV light transmittance.

Imperceptible to the eye is the quality difference between photoactivation modules employed for photopheresis. UV light absorbance by such modules is critical to the transmission of effective amounts of light to the collected cell fraction and drug.

The THERAKOS Photopheresis System uses only modules that conform to its strict standards for light transmission to target cells. UV meters intended to offer assurance for light delivery only measure light which arrives at the exterior surface of the modules - and, even then, at one point only. For the purpose of achieving predictable light transmittance to cells, the THERAKOS Photopheresis System monitors all film thickness and uses a multi-variable algorithm to calculate the amount of photoactivation time to ensure proper light dosage.

(3) The THERAKOS Photopheresis System has validated controls of critical parameters for safe and effective treatment.

The THERAKOS Photopheresis System monitors and responds to critical variables that would otherwise cause unpredictable therapeutic efficacy.

These include:

• Haematocrit
• Photoactivation Temperature
• Cell Volume
• UV Lamp Decay
• Cell Light Dose

(4) Only the THERAKOS Photopheresis System has a light source designed specifically for photopheresis application.

The UV light source of the THERAKOS Photopheresis System is a dedicated precision component. It delivers an even distribution of light across the cell fraction without “hot” or “cold” spots that might compromise therapy.

The normal decay over time of the light source is accounted for in an algorithm built into the System’s computer to ensure predictable light exposure for every treatment made. Other methods employ lamps that come from ordinary non-clinical applications and do not offer this same consistency and assurance.

(5) THERAKOS Photopheresis Method has an unparalleled safety profile and has undergone long-term safety monitoring patient follow-up.

Patients treated with this THERAKOS Photopheresis have been followed for up to eight years to ensure there is no additional risk of infections, autoimmune diseases or secondary cancers. No other method of photopheresis has undergone such intense monitoring.