PLYMOUTH AND BALATON, MN – Today Chitogen Inc., a medical hemostat manufacturer and trū® Chitosan, a division of The trū® Shrimp Companies, Inc., jointly announced the signing of a Letter of Intent for the supply of trū Chitosan for use in the market expansion of Chitogen’s patented and proprietary SoftSeal® interventional hemostat product line into the European Union and for continued development work and trials of trauma and surgical hemostats.
“This is truly a great development for Chitogen,” stated Albert Emola, President of Chitogen. “trū Chitosan is made in the US in an FDA facility to exacting USP [United States Pharmacopeia] monograph specifications. Their extraordinary, documented chain of custody will enable Chitogen to market our SoftSeal interventional hemostats into the very demanding regulatory environment of the European Union. This is a strategic priority for Chitogen, Inc.”
“trū Chitosan’s focus is on the medical applications of chitosan, and we are honored to be selected by Chitogen to be part of their future plans,” stated Michael Ziebell, President and CEO of The trū Shrimp Companies, Inc., producers of trū Chitosan. “Chitogen’s proprietary technology makes a difference to patients, and we are excited to be part of their expansion into the EU and aid in their further development of trauma and surgical hemostats.”
“trū Chitosan’s complete chain of custody is a critical element,” added Dr. James Drake, Chief Science Officer of Chitogen. “To obtain CE approval requires a precise, documented chain of custody and trū Chitosan’s is unmatched. trū Chitosan also enables our planned expansion into trauma and surgical hemostats for all markets. Production in the United States is very much a bonus.”
Chitosan is a natural polymer extracted and purified from the exoskeleton or shell of crustaceans. Unlike other chitosan producers, trū Chitosan has a documented chain of custody from shrimp postlarvae to purified chitosan. trū Chitosan is made from the shells of the shrimp grown in trū Shrimp’s Tidal Basin® controlled environment, free of disease, antibiotics and pollution. This ensures the quality and consistency of the original shell tissue and complete traceability for each lot of chitosan. The controlled indoor environment where the shrimp are grown is constantly monitored to ensure optimal growth and shrimp health conditions. The shrimp shell tissue is then harvested, preserved and further refined to produce chitosan that meets the high standards of USP. trū Chitosan not only provides a USP conforming Certificate of Analysis, but also a Certificate of Origin that documents the chain of custody from shrimp postlarvae to finished medical application chitosan.
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