Cerus Corporation

SUMMARY

Be ready, when minutes matter® with Pathogen Reduced Cryoprecipitated Fibrinogen Complex, also known as INTERCEPT® Fibrinogen Complex or IFC. INTERCEPT® Fibrinogen Complex is an immediately available*, pathogen reduced blood component for fibrinogen supplementation with a 5-day post-thaw shelf life. IFC contains fibrinogen, factor XIII, von Willebrand factor and other key clotting factors which are required for clot strength and hemostasis in patients with massive hemorrhage associated with fibrinogen deficiency.^1-4

The ability to safely store IFC thawed, at room temperature for up to 5 days, reduces wastage, minimizes wait times (improves turnaround times) and enables it to be pre-thawed and therefore immediately available for transfusion; giving clinicians a treatment option to protect patients against TTIs** and control bleeding associated with fibrinogen deficiency faster, when every minute matters.

______________________________________________________________________________________________________________________________________________________

MAIN

Fibrinogen and other key clotting factors decrease rapidly and significantly in hemorrhage.^5,6 Fibrinogen levels in cardiac (CV) surgery are an independent risk factor for severe hemorrhage, blood component utilization and mortality.^7,8 Early delivery of fibrinogen, factor XIII and von Willebrand factor adds the clotting strength needed to achieve stable clot formation and restore hemostasis.^4,5,9

Studies show that early fibrinogen supplementation improves patient outcomes^† by reducing blood component utilization, lowering mortality, shortening ICU stay and overall length of stay, and decreasing surgical procedures and wound infection.^11,12 Yet, a concentrated source of fibrinogen and other key clotting factors (e.g. cryo AHF¹³ and fibrinogen concentrates^14,15) is not available from the start due to inventory challenges, including long wait times due to the need to thaw or reconstitute (>45-60 minutes),^13,16-18 short shelf life (4-8 hours),¹⁹ and high wastage rates (7-33%).¹⁷ In >75% of US exsanguination cases, cryo AHF arrives too late to be medically efficacious.²⁰

Pathogen Reduced Cryoprecipitated Fibrinogen Complex, commonly referred to as INTERCEPT® Fibrinogen Complex or IFC, is a novel pathogen reduced blood component approved to treat and control bleeding, including massive hemorrhage, associated with fibrinogen deficiency. IFC is an immediate, enriched source of key clotting factors, including fibrinogen, factor XIII, von Willebrand Factor and other vital clotting proteins, required to facilitate hemostasis^1-4 in hemorrhaging patients, with a 5-day post-thaw shelf life.

IFC provides clinicians an immediate treatment option to protect patients against TTIs and control bleeding associated with fibrinogen deficiency faster, when every minute matters.

The ability to safely store IFC thawed for up to 5 days enables it to be pre-thawed and immediately available for transfusion with the first blood components, minimizing wait times and improving turnaround times. Plus, it significantly reduces or eliminates waste, because it can be returned to inventory if not transfused and reallocated to another patient.

IFC is produced from plasma pathogen reduced by the INTERCEPT Blood System for Plasma. Pathogen reduction by the INTERCEPT Blood System provides broad spectrum transfusion transmitted infection (TTI) risk reduction, including viruses (e.g. HIV), bacteria (e.g. staph infections), and other pathogens (e.g. parasites [babesia] and emerging pathogens [Zika, West Nile Virus, SARS]).^21,22** The INTERCEPT Blood System has 20 years of clinical and post-market surveillance experience.

Cerus Corporation is dedicated solely to safeguarding the world’s blood supply and aims to become the preeminent global blood products company. Headquartered in Concord, California, the company develops and supplies vital technologies and pathogen-protected blood components to blood centers, hospitals, and ultimately patients who rely on safe blood. The INTERCEPT Blood System for platelets and plasma is available globally and remains the only pathogen reduction system with both CE Mark and FDA approval for these two blood components. The INTERCEPT red blood cell system is under regulatory review in Europe, and in late-stage clinical development in the US. Also in the US, the INTERCEPT Blood System of Cryoprecipitation is approved for the production of Pathogen Reduced Cryoprecipitated Fibrinogen Complex (commonly referred to as INTERCEPT Fibrinogen Complex), a therapeutic product for the treatment and control of bleeding, including massive hemorrhage, associated with fibrinogen deficiency.

*INTERCEPT Fibrinogen Complex is available for immediate use for up to 5 days when stored thawed; when stored frozen, requires thawing prior to use.
**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. For a full list of pathogens, please refer to package Insert.
†These results are based on studies evaluating cryo AHF. Results with IFC may vary.

______________________________________________________________________________________________________________________________________________________

EDUCATIONAL LINKS

www.INTERCEPT-USA.com – learn more about other Cerus products

www.Cerus.com – learn more about Cerus Corporation

______________________________________________________________________________________________________________________________________________________

REFERENCES

1. Levy JH, et al. Fibrinogen as a therapeutic target for bleeding: a review of critical levels and replacement therapy. Transfusion 2014;54(5):1389-1405; quiz 1388.
2. Schroeder V, et al. Factor XIII: Structure and Function. Seminars in Thrombosis and Hemostasis 2016;42(4):422-428.
3. Peyvandi, F. Diagnosis and management of patients with von Willebrand’s disease in Italy: an Expert Meeting Report. Blood Transfusion 2018;16(4):326-328.
4. Chapin JC, et al. Fibrinolysis and the control of blood coagulation. Blood reviews 2015;29:17-24.
5. Rourke C, et al. Fibrinogen levels during trauma hemorrhage, response to replacement therapy, and association with patient outcomes. Journal of thrombosis and haemostasis:JTH 2012;10:1342-51.
6. Burggraf M, et al. Evaluation of clotting factor activities early after severe multiple trauma and their correlation with coagulation tests and clinical data. World J Emerg Surg. 2015 Sep 22;10:43.
7. Waldén K, et al. Low Preoperative Fibrinogen Plasma Concentration Is Associated With Excessive Bleeding After Cardiac Operations. The Annals of Thoracic Surgery 2014;97(4):1199-1206.
8. Ranucci M, et al. Fibrinogen Levels After Cardiac Surgical Procedures: Association With Postoperative Bleeding, Trigger Values, and Target Values. The Annals of Thoracic Surgery 2016;102(1):78-85.
9. Levy JH, et al. Fibrinogen and hemostasis: a primary hemostatic target for the management of acquired bleeding. Anesthesia and Analgesia 2012;114:261-74.
11. Pearse BL, et al. Protocol guided bleeding management improves cardiac surgery patient outcomes. Vox Sang 2015;109(3):267-79.
12. Hinton JV, et al. Association of perioperative cryoprecipitate transfusion and mortality after cardiac surgery. The Annals of Thoracic Surgery 2023.
13. AABB. Circular of Information for the Use of Human Blood and Blood Components. Bethesda, MD: AABB; 2021.
14. FIBRYGA®, Fibrinogen (Human) Lyophilized Powder for Reconstitution [package insert]. Paramus, NJ: Octapharma USA, Imc; December, 2020.
15. RIASTAP, Fibrinogen Concentrate (Human) Lyophilized Powder for Solution for Intravenous Injection. Kankakee, IL: CSL Behring LLC; July, 2021.
16. Holcomb JB, et al. Cryoprecipitate Use in the Prospective Observational Multicenter Major Trauma Transfusion study (PROMMTT). The journal of trauma and acute care surgery 2013;75:S31-S39.
17. Dunbar NM, et al. Blood component transfusion and wastage rates in the setting of massive transfusion in three regional trauma centers. Transfusion 2017;57:45-52.
18. Callum J, et al. Effect of Fibrinogen Concentrate vs Cryoprecipitate on Blood Component Transfusion After Cardiac Surgery: The FIBRES Randomized Clinical Trial. JAMA 2019:1-11.
19. Wagner SJ, Hapip CA, Abel L. Bacterial safety of extended room temperature storage of thawed cryoprecipitate. Transfusion 2019;59:3549-50.