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New Contracts Enable Broad Adoption of INTERCEPT® Platelets in France |  Cerus Enters into Collaboration with Central California Blood Center to Manufacture Pathogen Reduced Cryoprecipitate |  Cerus Workshop at SABM Annual Meeting |  Save the Date! The Cerus Industry Workshop at the Annual Meeting of the AABB |  Science Section: What We're Reading  |  Calendar of Events
New Contracts Enable Broad Adoption of INTERCEPT® Platelets in France
Cerus announced the signing of two, new, expanded contracts with Établissement Français du Sang (EFS), the French National Blood Service, for the INTERCEPT Blood System. The initial term of this platelet kit supply agreement is two years with two one-year extension options, supporting INTERCEPT platelet production in all EFS regional centers.

In January, the EFS was informed of the Ministry of Health’s decision that the INTERCEPT Platelet system should be deployed for the control of bacterial infections transmitted by transfusion, in accordance with a prior December 2016 recommendation by France’s regulatory authority, ANSM, the French National Agency for Medicines and Health Products Safety.

“We are proud that our decade long relationship with the EFS has led to an expanded supply agreement that supports a new standard of care,” said William ‘Obi” Greenman, Cerus’ president and chief executive officer. “Currently, approximately 10% of the annual platelet production in France is treated with the INTERCEPT system. We look forward to working with EFS to implement pathogen reduction throughout their system,” continued Greenman.


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Cerus Enters into Collaboration with Central California Blood Center to Manufacture Pathogen Reduced Cryoprecipitate
Cerus entered into an agreement earlier this month with the Central California Blood Center (CCBC) in which CCBC will manufacture pathogen-reduced cryoprecipitate (“cryo”) for the company. Cryoprecipitate is a blood product derived from blood plasma and contains coagulation factors VIII and XIII, fibrinogen, vWF, and fibronectin. Cryo is used in the control of bleeding associated with acquired fibrinogen deficiency. The current cryo products available today have a short post-thaw shelf life that limits their availability and contributes to significant wastage rates in the hospital setting.

“Cryo is a natural extension to our current FDA-approved INTERCEPT Blood System for Plasma. Following approval of a proposed premarket approval (PMA) supplement, INTERCEPT Plasma may be further manufactured into cryoprecipitate, for which we plan to seek an extended 5-day post-thaw storage claim.” stated William ‘Obi’ Greenman, Cerus’ president and CEO.

“We are very pleased to be working with the Cerus team in developing a next-generation cryoprecipitate product. We recognize the unmet need in the clinical community for a cryo product with an extended post-thaw shelf life, given the challenges faced by hospital blood banks today in regard to the high wastage rates associated with the short expiry of conventional cryo,” noted Christopher Staub, incoming president and CEO of CCBC.


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Cerus Workshop at SABM Portland, September 7, 2017
Join Cerus at the Society for Advancement of Blood Management (SABM) 2017 annual meeting in Portland, Oregon for a corporate workshop featuring Drs Laura Pizzi and Kathrine Prioli from the Center for Health Outcomes, Policy, and Economics (HOPE) at Rutgers University presenting “Cost Analysis for Hospital Implementation of Pathogen Reduced Platelets -An Interactive Model.” This workshop will describe the development and use of an interactive model that allows the hospital to assess the budgetary impact for different platelet component types, including pathogen reduced platelets and conventional platelets tested with a secondary bacterial test.

Download the Flier (pdf, 1.3MB)

 
Save the Date! Cerus Workshop at AABB San Diego, October 10, 2017
Save the Date! The Cerus industry workshop at the Annual Meeting of the AABB in San Diego, CA will be held on Tuesday Oct 10, 2017. “Experiences in Implementing Pathogen Reduction – From Maintaining Split Rates at the Blood Center to Treating Patients at the Hospital“ will feature topics including optimizing the availability of pathogen reduced products for patients while maintaining split rates, as well as a perspective on the significant patient benefits gained when receiving transfusion-ready pathogen reduced platelet products as discussed from a major university health system’s perspective.

AABB annual meeting
Science Section: What We’re Reading

Inactivation of Zika virus in platelet components using amotosalen and ultraviolet A illumination
Santa Maria F et al.Transfusion. 2017 Aug;57(8):2016-2025
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Comparing transfusion reaction rates for various plasma types: a systematic review and meta-analysis/regression
Saadah NH et al. Transfusion. 2017 Aug 2. Epub ahead of print.
Read the Abstract

Frequency of Trypanosoma cruzi parasitemia among infected blood donors with a potential association between parasite lineage and transfusion transmission.
Leigby DA et al. Transfusion. 2017;57;1426–1432.
Read the Abstract

Cases of transfusion-transmitted babesiosis occurring in nonendemic areas: a diagnostic dilemma
LeBel DP 2nd et al.Transfusion. 2017 Aug 7. Epub ahead of print.
Read the Case Study

Across state lines: Fulminant Babesia microti infection in a liver transplant recipient
Meissner EG, et al. Transpl Infect Dis.2017;e12741.
Read the Abstract
Calendar of Events

GCIAMT (Grupo Cooperativo Iberoamericano de Medicina Transfusional)
August 30- September 1, 2017 | Panama City, Panama

Additional Information

SABM (Society for the Advancement of Blood Management)
September 7-9, 2017 | Portland, OR

Additional Information

NCABB (North Carolina Association of Blood Bankers) 
September 10-12, 2017 | Charlotte, NC  
Additional Information


WABB (Wisconsin Association of Blood Banks)
September 12-13, 2017 | Appleton, WI 
Additional Information


ISABB (Indiana Blood Bank Association)
September 20-21, 2017 | Indianapolis, IN
Additional Information

AABB
October 7-10, 2017 | San Diego, CA  
Additional Information

ASA (American Society of Anesthesiologists)
October 21-25, 2017 | Boston, MA  
Additional Information
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.

CONTRAINDICATIONS: Contraindicated for preparation of plasma and platelet components intended for patients with a history of hypersensitivity reaction to amotosalen or other psoralens. Contraindicated for preparation of platelet and plasma 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 platelets and plasma are approved for use with the INTERCEPT Blood System. Use only the INTERCEPT INT100 Illuminator for UVA illumination of amotosalen-treated platelet and plasma components. No other source of UVA light may be used. Please refer to the Operator's Manual for the INT100 Illuminator. Discard any platelet or plasma components not exposed to the complete INT100 illumination process. Tubing components and container ports of the INTERCEPT Blood System 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: 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.

INTERCEPT Blood System for Red Blood Cells is in development and not available for sale.


Rx only. For full prescribing information, please see package insert.
MKT-EN 00165-25
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Cerus, INTERCEPT Blood System and INTERCEPT are registered trademarks of Cerus Corporation.

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