Navigation Links
Spectral granted IDE approval by U.S. FDA to conduct pivotal trial for Toraymyxin(TM)
Date:3/2/2010

TORONTO, March 2 /PRNewswire-FirstCall/ - Spectral Diagnostics Inc. (TSX:SDI), a company developing products for the treatment of sepsis, today announced that the U.S. Food and Drug Administration (FDA) has granted Investigational Device Exemption (IDE) approval for Toraymyxin(TM), a therapeutic hemoperfusion device that removes endotoxin from the bloodstream, allowing the Company to conduct a pivotal trial in the United States.

The EUPHRATES (Evaluating the Use of Polymyxin B Hemoperfusion in a Randomized controlled trial of Adults Treated for Endotoxemia and Septic shock) trial is a randomized, double-blinded control trial of standard of care versus standard of care and Toraymyxin(TM) directed by Spectral's Endotoxin Activity Assay (EAA(TM)), an FDA cleared assay for use in sepsis. The trial is expected to enroll approximately 360 patients at 15 sites throughout the U.S. and will have a primary end point of 28 day mortality.

"The FDA's approval of our IDE is a major step forward in the development of Toraymyxin(TM) for the U.S. market
'/>"/>

SOURCE Spectral Diagnostics Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related biology technology :

1. Spectral diagnostics Raises $14 million and enters into strategic collaboration with BioMS Medical to commercialize treatment for sepsis
2. First Spaceborne Hyperspectral Imager Will Use QImaging Rolera-MGi EMCCD Camera
3. Spectral appoints new board member
4. Spectral announces second quarter 2009 results
5. Spectral announces publication demonstrating Toraymyxin(TM) significantly reduces mortality from sepsis in prospective controlled trial
6. Spectral announces first quarter 2009 results
7. Spectral announces presentations at the 29TH International Symposium on Intensive Care and Emergency Medicine focusing on the role of endotoxin
8. Spectral announces 2008 financial results
9. Spectral signs exclusive license agreement to bring sepsis therapeutic to the U.S. market
10. Surface plasmon resonances of metal nanoparticles in array can have narrower spectral widths
11. Spectral announces third quarter 2008 results
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/27/2015)... ... August 27, 2015 , ... Inc. Magazine released its annual list ... as number 1,361 in growth for the three years through 2014. Being named to ... privately held organizations in the country. , “We are thrilled to make the ...
(Date:8/27/2015)... 27, 2015 In response to recent ... and The US Postal Service to no longer ... ,select agents, by the CDC, Marken reaffirmed today ... sensitive shipments. Marken uses its flexible ... and certified personnel to ensure the safe and ...
(Date:8/26/2015)... ... August 26, 2015 , ... ... today that a second US laboratory is to open in Manhattan, Kansas in ... continued partnership and long-term growth of research and development through collaboration with researchers ...
(Date:8/26/2015)... N.J. , Aug. 26, 2015  Roka Bioscience, ... focused on providing advanced testing solutions for the detection ... CEO will present at the Sidoti & Company Emerging ... conference will be held at the New York Marriott ... presentation will be available through the investor relations section ...
Breaking Biology Technology:iLab Solutions Named to 2015 Inc. 5000 List 2iLab Solutions Named to 2015 Inc. 5000 List 3Marken Ensures Safe Transportation Of Select Agents And Toxins 2MediVet Biologics Animal Health Secures Additional Laboratory Facility in Manhattan, Kansas 2MediVet Biologics Animal Health Secures Additional Laboratory Facility in Manhattan, Kansas 3
... , Jason S. Wood, Varian, ... , Cytochrome P450s (CYPs) ... human body 1 . CYPs are part of the Phase I ... the metabolized drug enabling either easy elimination of the drug or ...
... Z. Yang and S. Sadjadi, Varian, Inc. , ... Amphetamine drugs are often abused and misused in ... and doping laboratories are frequently asked to analyze for the presence ... sample volumes can be collected non-invasively. These drugs generally remain detectable ...
... cells through the B cell receptor or T cells through the ... different members of the same kinase families are used. ZAP-70 and ... and structures. Crosslinking of the CD3 receptor complex leads to the ... 1,2 . These kinases phosphorylate ITAM regions on the receptor which ...
Cached Biology Technology:Simultaneous Detection of CYP3A4, CYP2D6 and CYP2C9 Metabolites with a Single, Sensitive, LC/MS/MS Method 2Simultaneous Detection of CYP3A4, CYP2D6 and CYP2C9 Metabolites with a Single, Sensitive, LC/MS/MS Method 3Rapid Screening of Amphetamine Drugs in Urine by Positive Ion Electrospray LC/MS/MS 2Rapid Screening of Amphetamine Drugs in Urine by Positive Ion Electrospray LC/MS/MS 3Research Tools for Analysis of ZAP-70 2Research Tools for Analysis of ZAP-70 3
(Date:8/12/2015)... , August 12, 2015 ... of mobile payment innovation and advanced biometrics technology is ... the way consumers rely on using their credit cards, ... reinventing the future for payment services led by companies ... NXTD ), :  Google, Inc. (NASDAQ: GOOG ), ...
(Date:8/11/2015)... Today, ZUK announced its Android smartphone Z1, featuring FPC,s touch ... 2015 that relate to sales of FPC1155 for this smartphone model ... for 2015. Jörgen Lantto, CEO of FPC, comments: " ... manufacturer in China and we are proud ... for Z1 , its first ...
(Date:8/6/2015)... 6, 2015  Today, U.S. Congressman Mike ... ™ to learn firsthand how Silicon Valley technologies ... is a world leader in multi-factor identity management ... helping federal agencies and commercial organizations achieve new ... "The vast majority of network breaches can ...
Breaking Biology News(10 mins):Digital Wallet Devices & Mobile Payment Management Services Gain a Distinct Advantage in the Digital Payment Evolution as Demand Continues to Grow 2Digital Wallet Devices & Mobile Payment Management Services Gain a Distinct Advantage in the Digital Payment Evolution as Demand Continues to Grow 3Digital Wallet Devices & Mobile Payment Management Services Gain a Distinct Advantage in the Digital Payment Evolution as Demand Continues to Grow 4Digital Wallet Devices & Mobile Payment Management Services Gain a Distinct Advantage in the Digital Payment Evolution as Demand Continues to Grow 5Digital Wallet Devices & Mobile Payment Management Services Gain a Distinct Advantage in the Digital Payment Evolution as Demand Continues to Grow 6FPC's Touch Fingerprint Sensor FPC1155 in ZUK's Smartphone Z1 2Rep. Honda to Visit Crossmatch in Redwood City 2
... have had an accelerated childhood compared to that of modern ... by researchers from Ohio State University and the University of ... tooth growth present in the Neanderthal fossils they examined was ... , And since the rate of tooth growth has ...
... testing methods helped public health officials control and limit ... A virus in 2003 related to the consumption of ... the October 15 issue of The Journal of Infectious ... study, Joseph J. Amon, PhD, MSPH, and colleagues at ...
... testing methods helped public health officials control and limit ... A virus in 2003 related to the consumption of ... the October 15 issue of The Journal of Infectious ... study, Joseph J. Amon, PhD, MSPH, and colleagues at ...
Cached Biology News:Neanderthal teeth grew no faster than comparable modern humans' 2Neanderthal teeth grew no faster than comparable modern humans' 3Disrupting Cocaine-memories To Battle Addiction 2Large-scale Computer Simulations Reveal New Insights Into Antibiotic Resistance 2
... rat tissue extracts (liver, kidney, spleen, and heart) ... extract. It was also tested with microsomal fractions ... A simple and reliable method for measuring NDPase ... of the inorganic phosphate released from NDP by ...
Compound(s) tested through a broad panel of 38 ligand binding and enzyme assays targeting the Central Nervous System. Used to determine selecitivty and potential CNS-Side Effect liabilities of compo...
... through 63 ligand binding ... a broad therapeutic range. ... many non human tissue ... assays. Used to ...
... Receptor (PR) Competitor Assay Kits are ... progesterone receptor binding compounds using fluorescence ... a fusion of glutathione transferase to ... progesterone receptor [PR-LBD(GST)] and a proprietary, ...
Biology Products: