Spectral Diagnostics (EDTXF) 0.9100 $EDTXF
Spectral Medical Announces Completion of Enrolment for Its Pivotal EUPHRATES Clinical Trial
Marketwired - Mon Jun 20, 7:02AM CDT
Company expects to announce primary clinical outcome results by end of September
EDT.TO: 1.20 (-0.01)
Spectral Medical Announces Acceptance of Pre-Clinical PMA Module for Toraymyxin(TM) by FDA
Marketwired - Thu Jun 16, 7:02AM CDT
Company remains on track and anticipates final submission in Q4 2016
EDT.TO: 1.20 (-0.01)
Spectral Announces Voting Results of Annual Meeting
Marketwire Canada - Wed Jun 01, 9:12AM CDT
TORONTO, ONTARIO--(Marketwired - Jun 1, 2016) - Spectral Medical Inc. ("Spectral" or the "Company"
(TSX:EDT) (OTCQX:EDTXF), a Phase III company developing the first treatment for patients with septic shock guided by a companion diagnostic, today announced that at the annual meeting (the "Meeting" of shareholders of the Corporation ("Shareholders" that was held yesterday, all six nominees for the board were elected, the voting results of which are as follows:
EDT.TO: 1.20 (-0.01)
Spectral Medical Files Expanded Access Protocol With FDA for Toraymyxin(TM) Septic Shock Treatment
Marketwired - Tue May 31, 7:01AM CDT
Four patients remaining to enroll in the EUPHRATES clinical trial
EDT.TO: 1.20 (-0.01)
Spectral Announces First Quarter Results
Marketwired - Thu May 12, 7:02AM CDT
TORONTO, ONTARIO--(Marketwired - May 12, 2016) - Spectral Medical Inc., (TSX:EDT) (OTCQX:EDTXF), a Phase III company developing the first treatment for patients with septic shock guided by a companion diagnostic, today announced its unaudited financial results for the first quarter ended March 31, 2016.
EDT.TO: 1.20 (-0.01)
CORRECTION FROM SOURCE: Spectral Announces Fourth Quarter and Fiscal 2015 Results
Marketwired - Wed Mar 30, 11:49AM CDT
This document corrects and replaces the press release that was sent today at 8:00 a.m. The error occured in the 4th Paragraph in Financial Review where $14,048 should be $14,048,000. The complete and corrected version follows.
EDT.TO: 1.20 (-0.01)
Spectral Announces Fourth Quarter and Fiscal 2015 Results
Marketwired - Wed Mar 30, 7:02AM CDT
Spectral Medical Inc., (TSX: EDT) (OTCQX: EDTXF), a Phase III company developing the first treatment for patients with septic shock guided by a companion diagnostic, today announced its financial results for the fourth quarter and for the year ended December 31, 2015.
EDT.TO: 1.20 (-0.01)
Spectral Commends Inclusion of Organ Dysfunction in New Expert Consensus Definitions of Sepsis and Septic Shock
Marketwire Canada - Mon Mar 07, 6:00AM CST
Spectral Medical Inc. ("Spectral" or the "Company", (TSX:EDT) (OTCQX:EDTXF) a Phase III company advancing a precision treatment targeting specific patients at high risk of death from septic shock, today commented on the potential life-saving ramifications of the recently announced Third International Consensus Definitions for Sepsis and Septic Shock. Specifically, Spectral cites the definitions' new emphasis on organ dysfunction as a major contributor to the underlying pathology of sepsis and the main cause of death from septic shock. The updated definitions were issued on Feb. 23rd by a joint task force convened by the Society of Critical Care Medicine and the European Society of Intensive Care Medicine and published online by the Journal of the American Medical Association(1).
EDT.TO: 1.20 (-0.01)
Spectral Medical Provides Clinical and Regulatory Update
Marketwired - Mon Jan 11, 8:41AM CST
Spectral Medical Inc., ("Spectral" or the "Company" (TSX: EDT)(OTCQX: EDTXF), a Phase III company developing the first treatment for patients with endotoxemic septic shock that comprises a therapeutic device guided by a companion diagnostic, today announced that it is now recruiting the last 46 patients into its pivotal Phase III EUPHRATES trial. Based on current enrolment rates, it is expected that the trial should be completed in the first half of 2016.
EDT.TO: 1.20 (-0.01)
Spectral Announces Third Quarter 2015 Results
Marketwire Canada - Fri Nov 13, 7:00AM CST
Spectral Medical Inc., (TSX:EDT)(OTCQX:EDTXF), a Phase III company developing the first treatment for patients with septic shock that comprises a therapeutic device guided by a companion diagnostic, today announced its unaudited financial results for the third quarter ended September 30, 2015.
EDT.TO: 1.20 (-0.01)
Spectral Files Third Module of Rolling PMA Submission to FDA
Marketwire Canada - Thu Nov 12, 7:00AM CST
Spectral Medical Inc., ("Spectral" or the "Company" (TSX:EDT) (OTCQX:EDTXF), a Phase III company developing the first treatment for patients with septic shock that comprises a therapeutic device guided by a companion diagnostic, today announced that it has filed the third of four required Pre-Market Approval ("PMA"modules to the FDA. This module details the manufacturing processes for the Toraymyxin(TM) ("PMX" hemoperfusion cartridge. Spectral is in the later stages of a Phase III registration trial for PMX as it seeks FDA approval for this medical device in the United States. The fourth PMA module, related to clinical data, is expected to be filed by no later than the last quarter of 2016 as a final step towards anticipated FDA approval.
EDT.TO: 1.20 (-0.01)
Spectral Announces European Distribution Agreement With Fresenius Medical Care for Its Endotoxin Activity Assay (EAA(TM)) Diagnostic
Marketwired - Tue Nov 10, 7:04AM CST
Spectral Medical Inc., ("Spectral" or the "Company" (TSX: EDT)(OTCQX: EDTXF), a Phase III company developing the first treatment for patients with septic shock that comprises a therapeutic device guided by a companion diagnostic, today announced that it has entered into a non-exclusive agreement with Fresenius Medical Care Deutschland GmbH to distribute Spectral's FDA approved rapid test for the assessment of endotoxin activity in human whole blood (EAA(TM)) in eight European countries - Germany, Denmark, Sweden, Finland, Norway, Poland, Hungary and the Czech Republic. It is expected that the EAA(TM) will initially be sold in conjunction with the Toraymyxin(TM) ("PMX" hemoperfusion cartridge, a medical device which removes endotoxin from the bloodstream, to guide patient treatment. Spectral is now in the final stages of its Phase III registration trial in anticipation of FDA approval for PMX in the United States.
EDT.TO: 1.20 (-0.01)
Spectral Medical Announces Completion of Enrolment for Its Pivotal EUPHRATES Clinical Trial
Marketwired - Mon Jun 20, 7:02AM CDT
Company expects to announce primary clinical outcome results by end of September
EDT.TO: 1.20 (-0.01)
Spectral Medical Announces Acceptance of Pre-Clinical PMA Module for Toraymyxin(TM) by FDA
Marketwired - Thu Jun 16, 7:02AM CDT
Company remains on track and anticipates final submission in Q4 2016
EDT.TO: 1.20 (-0.01)
Spectral Announces Voting Results of Annual Meeting
Marketwire Canada - Wed Jun 01, 9:12AM CDT
TORONTO, ONTARIO--(Marketwired - Jun 1, 2016) - Spectral Medical Inc. ("Spectral" or the "Company"
(TSX:EDT) (OTCQX:EDTXF), a Phase III company developing the first treatment for patients with septic shock guided by a companion diagnostic, today announced that at the annual meeting (the "Meeting" of shareholders of the Corporation ("Shareholders" that was held yesterday, all six nominees for the board were elected, the voting results of which are as follows: EDT.TO: 1.20 (-0.01)
Spectral Medical Files Expanded Access Protocol With FDA for Toraymyxin(TM) Septic Shock Treatment
Marketwired - Tue May 31, 7:01AM CDT
Four patients remaining to enroll in the EUPHRATES clinical trial
EDT.TO: 1.20 (-0.01)
Spectral Announces First Quarter Results
Marketwired - Thu May 12, 7:02AM CDT
TORONTO, ONTARIO--(Marketwired - May 12, 2016) - Spectral Medical Inc., (TSX:EDT) (OTCQX:EDTXF), a Phase III company developing the first treatment for patients with septic shock guided by a companion diagnostic, today announced its unaudited financial results for the first quarter ended March 31, 2016.
EDT.TO: 1.20 (-0.01)
CORRECTION FROM SOURCE: Spectral Announces Fourth Quarter and Fiscal 2015 Results
Marketwired - Wed Mar 30, 11:49AM CDT
This document corrects and replaces the press release that was sent today at 8:00 a.m. The error occured in the 4th Paragraph in Financial Review where $14,048 should be $14,048,000. The complete and corrected version follows.
EDT.TO: 1.20 (-0.01)
Spectral Announces Fourth Quarter and Fiscal 2015 Results
Marketwired - Wed Mar 30, 7:02AM CDT
Spectral Medical Inc., (TSX: EDT) (OTCQX: EDTXF), a Phase III company developing the first treatment for patients with septic shock guided by a companion diagnostic, today announced its financial results for the fourth quarter and for the year ended December 31, 2015.
EDT.TO: 1.20 (-0.01)
Spectral Commends Inclusion of Organ Dysfunction in New Expert Consensus Definitions of Sepsis and Septic Shock
Marketwire Canada - Mon Mar 07, 6:00AM CST
Spectral Medical Inc. ("Spectral" or the "Company"
, (TSX:EDT) (OTCQX:EDTXF) a Phase III company advancing a precision treatment targeting specific patients at high risk of death from septic shock, today commented on the potential life-saving ramifications of the recently announced Third International Consensus Definitions for Sepsis and Septic Shock. Specifically, Spectral cites the definitions' new emphasis on organ dysfunction as a major contributor to the underlying pathology of sepsis and the main cause of death from septic shock. The updated definitions were issued on Feb. 23rd by a joint task force convened by the Society of Critical Care Medicine and the European Society of Intensive Care Medicine and published online by the Journal of the American Medical Association(1). EDT.TO: 1.20 (-0.01)
Spectral Medical Provides Clinical and Regulatory Update
Marketwired - Mon Jan 11, 8:41AM CST
Spectral Medical Inc., ("Spectral" or the "Company"
(TSX: EDT)(OTCQX: EDTXF), a Phase III company developing the first treatment for patients with endotoxemic septic shock that comprises a therapeutic device guided by a companion diagnostic, today announced that it is now recruiting the last 46 patients into its pivotal Phase III EUPHRATES trial. Based on current enrolment rates, it is expected that the trial should be completed in the first half of 2016. EDT.TO: 1.20 (-0.01)
Spectral Announces Third Quarter 2015 Results
Marketwire Canada - Fri Nov 13, 7:00AM CST
Spectral Medical Inc., (TSX:EDT)(OTCQX:EDTXF), a Phase III company developing the first treatment for patients with septic shock that comprises a therapeutic device guided by a companion diagnostic, today announced its unaudited financial results for the third quarter ended September 30, 2015.
EDT.TO: 1.20 (-0.01)
Spectral Files Third Module of Rolling PMA Submission to FDA
Marketwire Canada - Thu Nov 12, 7:00AM CST
Spectral Medical Inc., ("Spectral" or the "Company"
(TSX:EDT) (OTCQX:EDTXF), a Phase III company developing the first treatment for patients with septic shock that comprises a therapeutic device guided by a companion diagnostic, today announced that it has filed the third of four required Pre-Market Approval ("PMA"modules to the FDA. This module details the manufacturing processes for the Toraymyxin(TM) ("PMX" hemoperfusion cartridge. Spectral is in the later stages of a Phase III registration trial for PMX as it seeks FDA approval for this medical device in the United States. The fourth PMA module, related to clinical data, is expected to be filed by no later than the last quarter of 2016 as a final step towards anticipated FDA approval. EDT.TO: 1.20 (-0.01)
Spectral Announces European Distribution Agreement With Fresenius Medical Care for Its Endotoxin Activity Assay (EAA(TM)) Diagnostic
Marketwired - Tue Nov 10, 7:04AM CST
Spectral Medical Inc., ("Spectral" or the "Company"
(TSX: EDT)(OTCQX: EDTXF), a Phase III company developing the first treatment for patients with septic shock that comprises a therapeutic device guided by a companion diagnostic, today announced that it has entered into a non-exclusive agreement with Fresenius Medical Care Deutschland GmbH to distribute Spectral's FDA approved rapid test for the assessment of endotoxin activity in human whole blood (EAA(TM)) in eight European countries - Germany, Denmark, Sweden, Finland, Norway, Poland, Hungary and the Czech Republic. It is expected that the EAA(TM) will initially be sold in conjunction with the Toraymyxin(TM) ("PMX" hemoperfusion cartridge, a medical device which removes endotoxin from the bloodstream, to guide patient treatment. Spectral is now in the final stages of its Phase III registration trial in anticipation of FDA approval for PMX in the United States. EDT.TO: 1.20 (-0.01)
