About Sepsis
BioMS Medical and Spectral Diagnostics Inc. (TSX:SDI) announced a strategic collaboration on December 17, 2009. Spectral is a leader in the fight against sepsis.
Sepsis
Sepsis is a life-threatening illness. Your body's response to a bacterial infection usually causes it. Your immune system goes into overdrive, overwhelming normal processes in your blood. The result is that small blood clots form, blocking blood flow to vital organs. This can lead to organ failure. Babies, old people and those with weakened immune systems are most likely to get sepsis. But even healthy people can become deathly ill from it. A quick diagnosis can be crucial, because one third of people who get sepsis die from it. (Source: Medline Plus)
Sepsis affects approximately 750,000 patients in the US each year. It accounts for approximately 1 in 10 ICU admissions at an annual cost to the US healthcare system of $17 billion. Sepsis is the 10th most common cause of death in the US, ahead of acute heart attacks and breast cancer.
About Toraymyxin™
Spectral obtained exclusive rights for the Toraymyxin™ device in the US from Toray Industries Inc., of Japan, in March of 2009 and, following the closing of the financing (the “Closing”), anticipates initiating a pivotal US clinical trial in the first half of 2010. Toraymyxin™ 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.
About Endotoxin
Spectral’s Endotoxin Activity Assay (EAA™) is the only FDA cleared assay for the measurement of endotoxin in the bloodstream. Toraymyxin™ is a therapeutic hemoperfusion device that removes endotoxin from the bloodstream. The anticipated US pivotal trial will use Spectral’s EAA™ to identify patients with severe sepsis who have elevated endotoxin in the blood and will most likely benefit from treatment with Toraymyxin™.
Trial Results
Results of a randomized controlled trial (the EUPHAS trial) were recently published in the Journal of the American Medical Association (JAMA. 2009; Vol. 301 No. 23, 2445-2452). The results demonstrated that Toraymyxin™ absorbs endotoxin from the bloodstream, and when added to conventional therapy, significantly improved hemodynamics and organ dysfunction, and reduced 28-day mortality in patients with severe sepsis and septic shock in comparison to those patients in the conventional therapy group.