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news.Spectral Diagnostics, a medical diagnostics company, has signed a licensing agreement with Japan-based Toray Industries granting Spectral the exclusive development and commercial rights in the US for Toraymyxin, a therapeutic device for the treatment of sepsis that removes endotoxin from the bloodstream.
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Under the terms of the agreement, Spectral will seek FDA approval for Toraymyxin and intends to commercialize the product together with its endotoxin activity assay (EAA), the only FDA cleared diagnostic for the measurement of endotoxin.
Spectral plans to conduct a pre-investigational device exemption meeting with the FDA this quarter as a first step towards gaining clearance for its clinical strategy, with the objective of initiating clinical trials in the latter half of 2009.
Paul Walker, president and CEO of Spectral, said: “The finalization of this agreement, on schedule, is an important milestone for Spectral and demonstrates the significant progress we have made on our path to delivering an effective treatment for severe sepsis in the US.
“Furthermore, together with our proprietary EAA, the combination has demonstrated a significant reduction in the mortality of patients with severe sepsis compared to standard of care in European clinical trials.”