THERAKOS™ CELLEX™ Photopheresis System

CELLEX™ System average treatment time¹

• Single-needle mode: 103.0 mins
• Double-needle mode: 74.4 mins

Reassurance for physicians and operators, comfort for the patient

• Flexibility of switching between single- or double-needle modes during the procedure¹
• Enables adapting to the patients’ venous access conditions
• Peristaltic pumps provide smooth vein pressure⁴
• Gives confidence to you and comfort to your patients
• Because your patient remains connected throughout the procedure:
• Minimal re-infusion errors and risk of cross-contamination^2,3
• Minimal risk of microbial contamination^2,3

1. Bisaccia E, et al. Br J Dermatol. 2009;161(1):167-169. 2. Knobler R, et al. J Eur Acad Dermatol Venereol. 2020;34(12):2693-2716. 3. Perotti C, Sniecinski I. Transfus Apher Sci. 2015;52(3):360-368. 4. Operator’s Manual. THERAKOS^TM CELLEX^TM Photopheresis System. Therakos. 2019.

CELLEX™ System provides the versatility to treat a wide range of patient types

Vascular access

Choice of single- or double-needle mode and ability to switch between the two according to venous access conditions

Different disease states

Spectrum of white blood cells is collected, making treatment applicable to various disease states

Abnormal lipid and bilirubin in plasma

Bowl optic sensor allows customisation of the system to the needs of abnormal plasma conditions

No lower limit for leukocyte levels

Continuous collection and separation enables treatment even with low leukocyte levels

Adjustable to cardiac, pulmonary or renal function

Fluid shifts minimised in double-needle mode

The CELLEX^TM System automatically manages treatment

Automated photosensitising agent dosing calculations help minimise dosage errors¹

Specific algorithm for consistent UVA irradiation automatically calculates and sets photoactivation time according to lamp life, % haematocrit and treatment volume¹

UVA, ultraviolet A.

1. Operator’s Manual. THERAKOS^TM CELLEX^TM Photopheresis System. Therakos. 2019.

CELLEX™ System automatically controls collection

Bowl optic sensor automatically identifies the red cell layer¹

Allows automated adaptation to the patient’s plasma conditions and delivery of a consistent buffy coat

Automated flow rate controls reduce the need for operator interventions¹

Haematocrit sensor provides automated detection of haematocrit¹

Automatically determines when buffy coat collection should end and final data automatically informs photoactivation time

1. Operator’s Manual. THERAKOS^TM CELLEX^TM Photopheresis System. Therakos. 2019.

Key features of the CELLEX™ System

• The world’s only fully integrated and validated platform for ECP¹
• Single, uninterrupted sterile fluid path
• Automated flow rate controls²
• Minimises the need for operator intervention

Fully integrated and validated technology

• One technology interface (integrated touchscreen)
• One kit (single/double needle) for all procedures
• Single contact for procedural reporting
• Compact mobile system, easily moved if required*
  
  

*Contact your Therakos representative if you intend to move the CELLEX™ device within your unit.

ECP, extracorporeal photopheresis.

1. Knobler R, et al. J Eur Acad Dermatol Venereol. 2020;34(12):2693-2716. 2. Operator’s Manual. THERAKOS™ CELLEX™ Photopheresis System. Therakos. 2019.

• The CELLEX^TM System allows you to treat patients with integrated and validated technology.
• Use of bespoke combinations of separate instruments for ECP constitutes “off-label” use
• The treatment decision and justification rests with the physician or treatment centre^1-3
• EU regulation supports use of devices outside their Instructions For Use only if an equivalent approved device is not available on the market⁴

European patent⁵

Cassette for controlling the movement of blood and separated blood components

EC Declaration of Conformity^6,7

Medical Device Directive 93/42/EEC

Can be used safely with the materials, substances and gases with which they enter into contact

Performance is maintained in accordance with the intended use

CE 2797⁸

Design, development and manufacture of the THERAKOS™ CELLEX™ Photopheresis System (including the Instrument, Light Assembly and Procedural Kits)⁹

ISO 13485:2016 & EN ISO 13485:2016 certified^*7

Therakos Quality Management System (certified for the design, manufacture, distribution and service of Photopheresis System)

*Certified by a Notified Body (BSI Certificate of Registration number MD 665632).

BSI, British Standards Institution; CE, Conformité Européene; EC, European Council; ISO, International Organization for Standardization; ECP, extracorporeal photopheresis; EU, European Union.

1. European Directorate for the Quality of Medicines & Healthcare (EDQM). Guide to the quality and safety of tissues and cells for human application. 3rd ed. 2017. 2. European Council. Council Directive 85/374/EEC. 3. Notified Bodies Medical Devices (NB-MED). Recommendation NB-MED/2.5.1/Rec5. 4. European Parliament and European Council. Regulation EU 2017/745. 5. European Patent Office. EP1512420B1. March 9, 2005. Available at: https://worldwide.espacenet.com/publicationDetails/originalDocument?FT=D&date=20081119&DB=&locale=en_EP&CC=EP&NR=1512420B1&KC=B1&ND=4. Accessed February 2022. 6. European Council. Council Directive 93/42/EEC. 7. Therakos (UK) Ltd. Data on file - ref-04301. 8. Knobler R, et al. J Eur Acad Dermatol Venereol. 2020;34(12):2693-2716. 9. Therakos (UK) Ltd Data on file Ref 06130.