Fibrin Sealant/Thermogenesis
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CryoSeal Fibrin Sealant System; CryoSeal FS System; CSS; cryoprecipitate plus thrombin, autologous
Status: recently approved in U.S.; marketed in Europe
Organizations involved:
Thermogenesis Corp. – Manuf.; R&D; Tech.; USA mark.
Misc. companies – Europe mark.
Cross ref.: See the entries for Fibrin Sealants (#735) and the Factor VIII, cryoprecipitate (#716).
Description: The CryoSeal FS System is a automated cryogenic separation device (free-standing machine) and companion sterile blood processing disposables used to prepare fibrin sealants, i.e., cryoprecipitate rich in fibrinogen (and Factor VIII other clotting factors) and thrombin, from platelet-depleted plasma in about an hour from a unit of blood taken from a single patient for autologous transfusion (back into the donor). The CryoSeal FS System simultaneously produces fibrin sealant components (fibrinogen-rich cryoprecipitate and thrombin) from a single unit of autologous or single donor plasma in about one hour. In addition to fibrinogen and thrombin, CryoSeal Fibrin Sealant also contains concentrated amounts of critical clotting factors, including Factor VIII, Factor XIII, von Willebrand’s Factor and fibronectin.
... truncated (just the beginning)
Annual sales (2008; $million): (reserved for subscribers)
Annual sales (2009; $million): (reserved for subscribers)
Annual sales (2010; $million): (reserved for subscribers)
Annual sales (2011; $million): (reserved for subscribers)
Annual sales (2012; $million): (reserved for subscribers)
Index Terms:
Companies involvement:
Partial monograph text:
739 Fibrin Sealant/Thermogenesis
Nomenclature:
Fibrin Sealant/Thermogenesis [BIO]
CryoSeal Fibrin Sealant System [TR]
cryoprecipitate plus thrombin, autologous [SY]
CryoSeal FS System [SY]
CSS [SY]
FDA Class: Device PMA
Year of approval (FDA) = 2007
Annual sales (2007; $million): (reserved for subscribers)
Biosimilars/biobetters Data
U.S.A.
European Union (EU)
Biosimilars/biobetters-related U.S. Patents: Reserved for subscribers]
U.S. Patent Expiration Year: Reserved for subscribers
U.S. Biosimilars Data Exclusivity Expiration: Reserved for subscribers
U.S. Biosimilars Orphan Exclusivity Expiration: Reserved for subscribers
U.S. Biosimilars Launchability Year: Reserved for subscribers
U.S. Biobetters Launchability Year: Reserved for subscribers
Biosimilars/biobetters-related EU Patents: Reserved for subscribers
EU Patent Expiration Year: Reserved for subscribers
EU Biosimilars Data Exclusivity Expiration: Reserved for subscribers
EU Biosimilars Orphan Exclusivity Expiration: Reserved for subscribers
EU Biosimilars Launchability Year: Reserved for subscribers
EU Biobetters Launchability Year: Reserved for subscribers
antihemophilic factors
biopharmaceutical products
blood products
fibrin
human materials used<!-- humansource -->
Factor VIIa murine monoclonal antibody
fibrin
fibrinogen
Plasma (Human)
three-demensional cell culture
thrombin, human
wet cryo
approval dates uncertain (FDA reports erroneous, conflicting, or simply has lost the original approval dates) (FDAapproved)
EU200 Currently Approved in EU
UM001 Marketed Product in US
US200 Currently Approved in US
EM001 Marketed Product in EU
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