Blood safety is changingTransfusion-transmitted infections (TTI) persist despite interventions used to reduce risk. Bacterial contamination presents the most significant infectious risk, followed by emerging pathogens such as dengue, chikungunya, and Zika viruses.

The INTERCEPT Blood System for Platelets and PlasmaPathogen reduction is recognized by FDA35 and AABB as an effective strategy to reduce the risk of transfusion- transmitted infections (TTI) and potentially reduce the risk of transfusion associated graft versus host disease (TA-GVHD).

The INTERCEPT Blood System provides robust inactivation, reducing risk due to:

- Bacteria frequently implicated in septic transfusion reactions

- Emerging pathogens, such as chikungunya, dengue, Zika

- Established threats such as HIV, HBV, HCV

- T-cells implicated in TA-GVHD

INTERCEPT® Blood System for Platelets and Plasma pathogen reduction system

Targeting DNA and RNA to prevent pathogen proliferation

The INTERCEPT System uses amotosalen, a well characterized photoactive compound that specifically targets DNA and RNA, and UVA illumination to irreversibly cross-link nucleic acids. In doing so, the INTERCEPT treatment blocks replication of viruses, bacteria, and parasites, rendering them inactive.1

1. Amotosalen targets nucleic acids, and intercalates or “docks” between nucleic acid base pairs.

2. UVA illumination activates amotosalen, initiating permanent cross-links between the helical strands.

3. Cross-linking prevents further replication and inactivates the pathogen and/or leukocyte.

UVA ILLUMINATION

TARGETING

AMOTOSALEN

Crosslinks UponUVA Illumination2 Blocks Replication,

Transcription and Translation3Intercalates into Regionsof DNA and RNA1

Broad spectrum inactivationRobust inactivation is achieved with ≥4 log reduction for most clinically relevant pathogens when using the INTERCEPT Blood System.

Platelets in65% PAS-3/ 35% plasma

Platelets in100% plasma Plasma

Bacteria (gram-negative, gram-positive, spirochetes)

Log Reduction

(cfu/mL)a

Escherichia coli ≥6.3 >5.9 c

Yersinia enterocolitica ≥5.9 >6.3 ≥6.6

Klebsiella pneumoniae 5.8 5.9 ≥6.7

Serratia marcescens ≥6.7b >7.1 c

Staphylococcus epidermidis ≥6.1 >6.1 ≥6.6

Staphylococcus aureus ≥5.4 ≥6.1 c

Streptococcus pyogenes ≥6.8b >6.1 c

Bacillus cereus (vegetative) ≥5.5 ≥5.6 c

Clostridium perfringens (vegetative) ≥6.5 >6.0 c

Propionibacterium acnes ≥6.5 >6.7 c

Treponema pallidum (Syphilis) ≥6.4 d ≥5.4

Borrelia burgdorferi (Lyme disease) ≥6.8 d ≥9.9

Protozoan Parasite Log Reduction(pfu or cfu/mL)a

Plasmodium falciparum ≥5.6 d ≥5.9

Babesia microti ≥4.9 d ≥4.9

Trypanosoma cruzi ≥5.3 >5.5 >5.0

a. Based on input titer and post-treatment titer in 1 mL. b. Based on culture of full platelet unit (300 mL). c. Not tested d. Study in progress

Virus (enveloped and non-enveloped)

Log Reduction (pfu/mL)a

HIV-1, cell-associated ≥5.4 ≥4.7 ≥6.1

DHBV (model virus for HBV) ≥4.8 ≥4.3 4.4 to 4.5

BVDV (model virus for HCV) ≥4.4 >3.3 ≥4.5

HTLV-I 4.7 c ≥4.1

HTLV-II ≥5.1 c ≥4.7

West Nile virus (WNV) ≥5.7 >3.7 ≥6.7

Chikungunya virus (CHIKV) ≥5.7 >6.5 6.5

Dengue virus ≥4.3 3.6 c

Cytomegalovirus (CMV) ≥4.9 c c

Pseudorabies virus (model for CMV) c ≥4.2 c

Influenza A virus ≥5.9 c ≥5.7

Bluetongue virus (model non-enveloped virus) 4.4 c ≥4.0

Adenovirus 5 c c ≥5.7

Parvovirus B19 c c 1.8

Leukocyte Log Reduction

Human T-cells 4.0 4.0 4.0

Platelets in65% PAS-3/ 35% plasma

Platelets in100% plasma Plasma

For a full list of pathogens, see package insert. There is no pathogen inactivation process that has been shown to eliminate all pathogens. Certain non-enveloped viruses (e.g., HAV, HEV, B19 and poliovirus) and Bacillus cereus spores have demonstrated resistance to the INTERCEPT process.

Learn more with these links:

How INTERCEPT works bit.ly/2wYL257

INTERCEPT Processing Video bit.ly/2wnjbIe

Clinical trials show safety and efficacy of INTERCEPT Platelets. bit.ly/2fgygWl

Who is using INTERCEPT in the US? bit.ly/2xiYeT8

Proven safe and effective

INTERCEPT Platelets• Approved for use with Amicus apheresis platelets in

PAS-3 or Trima apheresis platelets in 100% plasma.

• Evaluated in numerous clinical trials in which over1000 subjects received INTERCEPT-treated Platelets.12-19

• Shown safe in routine use through hemovigilance programs covering >400,000 INTERCEPT-treated platelet components.20-22, 33,34

• Demonstrated prevention of septic transfusion reactions due to bacterial contamination when using INTERCEPT Platelets in routine settings.20-22

INTERCEPT Plasma• Approved for use with whole blood derived or apheresis

plasma.

• Evaluated in eight clinical studies, involving over 600 patients requiring plasma transfusion.23-26

• Shown safe in routine use through hemovigilance programs covering over 200,000 INTERCEPT-treated plasma components.21,27,28

• Demonstrated effective retention of coagulation factors as shown through an in vitro study in which functional activity of plasma proteins was evaluated.29

INTERCEPT Platelets and Plasma demonstrate safety and therapeutic efficacy as supported by numerous clinical trials and hemovigilance programs.

INTERCEPT processingThe INTERCEPT Blood System is comprised of separate disposable kits for platelets and plasma as well as a UVA Illuminator.

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GLOBAL HEADQUARTERS | 2550 Stanwell Drive | Concord, CA US 94520 | 855.835.3523

www.cerus.com | www.intercept-usa.com

Rx only. There is no pathogen reduction process that has been shown to eliminate all pathogens. Certain non-enveloped viruses (e.g., HAV, HEV, B19 and poliovirus) and Bacillus cereus spores have demonstrated resistance to the INTERCEPT process. For CONTRAINDICATIONS, WARNINGS, and REFERENCES, see fold-out back cover. See package insert for full prescribing information.

CONTRAINDICATIONS

Contraindicated for preparation of plasma or platelet components intended for patients with a history of hypersensitivity reaction to amotosalen or other psoralens. Contraindicated for preparation of plasma or platelet components intended for neonatal patients treated with phototherapy devices that emit a peak energy wavelength less than 425 nm, or have a lower bound of the emission bandwidth <375 nm, due to the potential for erythema resulting from interaction between ultraviolet light and amotosalen.

WARNINGS AND PRECAUTIONS

Only INTERCEPT Processing Sets for plasma or platelets are approved for use in the INTERCEPT Blood System. Use only the INT100 Illuminator for UVA illumination of amotosalen-treated plasma or platelet components. No other source of UVA light may be used. Please refer to the Operator’s Manual for the INT100 Illuminator. Discard any plasma or platelet components not exposed to the complete INT100 illumination process.

Tubing components and container ports of the INTERCEPT Blood System for Plasma or Platelets contain polyvinyl chloride (PVC). Di(2-ethylhexyl)phthalate (DEHP) is known to be released from PVC medical devices, and increased leaching can occur with extended storage or increased surface area contact. Blood components will be in contact with PVC for a brief period of time (approx. 15 minutes) during processing. The risks associated with DEHP released into the blood components must be weighed against the benefits of therapeutic transfusion.

PLATELETS: Pulmonary events: Acute Respiratory Distress Syndrome (ARDS). INTERCEPT processed platelets may cause the following adverse reaction: Acute Respiratory Distress Syndrome (ARDS). An increased incidence of ARDS was reported in a randomized trial for recipients of INTERCEPT processed platelets, 5/318 (1.6%), compared to recipients of conventional platelet components (0/327). Monitor patients for signs and symptoms of ARDS.

PLASMA: Amotosalen-treated plasma may cause the following adverse reaction: Cardiac Events. In a randomized controlled trial of therapeutic plasma exchange (TPE) for TTP, five patients treated with INTERCEPT Blood System processed plasma and none with conventional plasma had adverse events in the cardiac system organ class (SOC) reported. These events included angina pectoris (n=3), cardiac arrest (n=1), bradycardia (n=1), tachycardia (n=1) and sinus arrhythmia (n=1). None of these events resulted in documented myocardial infarction or death. Monitor patients for signs and symptoms of cardiac events during TPE for TTP.

References 1) Stramer SL,et al. Transfusion 2009;49(Suppl 2):1S-29S. 2) Dodd RY. Practical transfusion medicine. 4th ed. Chichester: Wiley; 2013. p. 161-7. 3) Murphy WG, et al. Vox Sang 2008;95:13-9. 4) Dumont LJ, et al. Transfusion 2010;50:589-99. 5) Jacobs MR et al. Transfusion 2011;51:2573-82. 6) Pearce S, et al. Transfus Med 2011;21:25-32. 7) www.aabb.org/tm/coi. 8) “Standards for Blood Banks and Transfusion Services,” AABB, 30th edition, 2015. 9) AABB Weekly Report, January 15, 2016. 10) INTERCEPT Blood System for Platelets–Dual Storage (DS) Processing Set Package Insert, March 15, 2016. 11) Department of Health and Human Services, Food and Drug Administration (FDA); “Requirements for Blood and Blood Components Intended for Transfusion for Further Manufacturing Use; Final Rule; Federal Register; Vol. 80, No. 99; May 22, 2015;Rules and Regulations. 12) Snyder E, et al. Transfusion 2004;44:1732-1440. 13) Corash, L, et al. Transfusion 2000;40(S10):137. 14) Slichter SJ, et al. Transfusion 2006;46:731-740. 15) McCullough J, et al. Blood 2004;104(5):1534-41. 16) Janetzko K, et al. Transfusion 2005;45(9):1443-1452. 17) van Rhenen DJ, et al. Blood 2003;101:2426-2433. 18) Schlenke P, et al. Ann Hematol 2011;90(12):1457-65. 19) Infanti L, et al. Transfus Apher Sci 2011;45(2):175-81. 20) Sweeney J, Lozano M. Platelet Transfusion Therapy. Bethesda: AABB Press, 2013. 21) French National Agency for Medicine and Health Product Safety/ANSM, Hemovigilance Activity Reports, 2009 - 2014. 22) SwissMedic Haemovigilance Annual Reports, 2010 - 2015. 23) Hambleton J et al. Transfusion 2002;42:1302-1307. 24) de Alarcon P et al. Transfusion 2005;45:1362-1372. 25) Mintz PD et al. Blood 2006;107:3753-3760. 26) Mintz PD et al. Transfusion 2006;46:1693-1704. 27) Cazenave JP et al. Transfusion 2010;50:1210-1219. 28) Bost V et al. Vox Sanguinis 2013;104:337-341. 29) INTERCEPT Blood System for Plasma Package Insert, Cerus Corporation; Aug. 17, 2015. 30) Schmidt MS, et al. Vox Sang 2011;101(S1):226. 31) Nussbaumer W et al. Transfusion 2007;47(7):1125-33. 32) Lin L, et al. Transfusion 2004;44:1496 - 1504. 33) 2008 Transfusion Data. Cazenave, J.P., Isola, A., Dientz D. (2013). 34) Knutson F et al. Vox Sanguinis 2015. 35.) Food and Drug Administration; “Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion - Draft Guidance for Industry”

Global adoption of the INTERCEPT® Blood System

Kits Sold to Produce Nearly

4,500,000 Transfusable Units

Customer Experience of Over

15 Years in Routine Use

Routine Use in Over

150 25 Centers Countries

in

The INTERCEPT Blood System for Platelets and Plasma

Commercially Available Regulatory Activity Initiated /Application Pending ReviewCenters in Routine Use