On 19 October, 2015 Spectral Medical Inc. (EDT.TO) (EDTXF) filed a report comprised of all available published literature (peer-reviewed articles, observational studies and case reports) reporting the use of Toraymyxin™ (PMX) over a 22 year period from 1993 to September 2015, with the FDA. Toray Medical Co., Ltd. (TMC) is the distributor for EAA™ (Spectral's rapid test for the assessment of endotoxin activity in human whole blood) in Japan. The press release on October 21, 2015 revealed that Spectral has entered into an exclusive distribution agreement with TMC to market EAA in the Middle and Far East countries comprising of Saudi Arabia, India, South Korea, Taiwan, Singapore, Thailand, Malaysia, Indonesia, Philippines, Vietnam, Cambodia, Myanmar, Brunei, Laos, and Turkey.
Spectral initiated the EUPHRATES Phase 3 clinical trial in June 2010 and had 15 sites up and running by the end of 2012. The EUPHRATES trial is screening approximately 125 patients per week, with most patients not qualifying due to not meeting the vasopressor requirements, not having a MODS score 9, or not having an elevated EAA score. The primary outcome of the EUPHRATES trial is now 28-day all-cause mortality in patients that are in severe septic shock with EAA 0.6 and a MODS score of 9.
This compares to $4.0 million in operating expenses for the first quarter of 2014, with the decrease due almost entirely to fewer new sites being initiated in the EUPHRATES trial. Spectral management plans to perform that analysis on these amended protocol patients enrolled through the end of the third quarter 2014.