Spectral Diagnostics enters into strategic collaboration with BioMS Medical to commercialize treatment for sepsis
Spectral Diagnostics Inc. and BioMS Medical Corp. announced that BioMS Medical and a syndicate of investors have invested $14 million in Spectral Diagnostics to advance Toraymyxin(TM), a treatment for severe sepsis, towards regulatory approval and commercialization in the United States.
Spectral obtained exclusive rights for the Toraymyxin(TM) device in the US from Toray Industries Inc., of Japan, in March of 2009 and, following the closing of the financing, anticipates initiating a pivotal US clinical trial in the first half of 2010. Toraymyxin(TM) has been used in more than 70,000 patients globally and has demonstrated in clinical trials that it safely and effectively removes endotoxin and reduces mortality in patients with severe sepsis. There are approximately 125,000 patients who develop endotoxemia related severe sepsis in the US each year and who currently face a high risk of mortality with limited treatment options, representing a potential market opportunity in excess of $1 billion per annum.
"We are now focused on obtaining clearance from the FDA to initiate the pivotal US trial - a randomized double blinded prospective trial, comparing standard of care versus standard of care plus Toraymyxin (TM), in patients with proven endotoxemia," said Dr. Paul Walker, President and CEO of Spectral. "The resources from this investment, combined with the clinical, regulatory and capital market expertise of the BioMS team, will assist Spectral to effectively conduct its anticipated pivotal trial in the US."
"The use of a specific diagnostic test, the EAA(TM), to identify endotoxin, a substance that is known to be harmful to the body, and proceed to remove it with the Toraymyxin(TM) column makes this study unique in the history of sepsis clinical trials," said Dr. R. Phillip Dellinger, Professor of Medicine, University Medicine and Dentistry New Jersey, Head, Division of Critical Care Medicine, Department of Medicine, Cooper University Hospital, Camden New Jersey and primary investigator for the study. Cooper University Hospital will also be the coordinating center for the clinical trial.
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