Business
Spectral announces fourth quarter and fiscal 2012 results
TORONTO, March 27, 2013 /CNW/ - Spectral Diagnostics Inc., (TSX:SDI) (OTCQX: DIAGF) , a Ph...
About this update from Spectral Medical Inc
[{"type":"text","content":"\n\n\n\n\n\nTORONTO, March 27, 2013 /CNW/ - Spectral Diagnostics Inc., (TSX:SDI) (OTCQX: DIAGF), a Phase III company developing the first theranostic treatment for\n patients with septic shock, today announced its audited financial\n results for the fourth quarter and year ended December 31, 2012.\n\n\n2012 Highlights:\n\n\nContinued enrolling patients into the Company's Phase III EUPHRATES\n trial at a per site rate that is higher than previous sepsis trials.\n Directed by the Company's Endotoxin Activity Assay (EAA™), which is the\n only FDA-cleared diagnostic for the risk of developing sepsis,\n Spectral's EUPHRATES trial is currently targeted to enroll 306\n evaluable patients at up to 60 sites in North America. Contingent on\n maintaining current enrolment rates and timely site start ups, the\n trial should be fully enrolled by the end of 2014.\n\nAs of March 25, 2013, 100 patients have been randomized into Spectral's\n EUPHRATES trial.\n\nAnnounced an exclusive distribution agreement with Toray International\n Italy S.r.l. - a subsidiary of Toray Industries, Inc. - to sell the\n Company's Endotoxin Activity Assay in combination with Toraymyxin in\n Saudi Arabia and Turkey. The expansion of commercial jurisdictions with\n Toray further confirms the outstanding market opportunity for the\n Company's unique theranostic treatment for septic shock.\n\nSubsequent to year end, announced that the first interim analysis has\n been conducted on the initial 76 randomized patients in its EUPHRATES\n trial. The Data and Safety Monitoring Board (DSMB), consisting of\n experts in the fields of critical care medicine, infectious disease,\n nephrology, biostatistics and regulatory affairs, reviewed the totality\n of the data set for evidence of safety concerns, such as adverse events\n and/or adverse device effects, related to the use of the Toraymyxin\n cartridge. The results from the first interim safety analysis by the\n DSMB state that there are no safety issues to date concerning the\n application of the Toraymyxin cartridge to patients in the EUPHRATES\n trial. In addition, the results state that the EUPHRATES clinical\n protocol appears to be defining the correct target patient population\n for this study.\n\nConcluded the reporting period with approximately $10.5 million in cash,\n cash equivalents and short- term investment...