Navigation Links
Spectral signs exclusive license agreement to bring sepsis therapeutic to the U.S. market
Date:3/9/2009

TORONTO, March 9 /PRNewswire-FirstCall/ - Spectral Diagnostics Inc. (TSX:SDI) today announced that it has signed a license agreement with Toray Industries, Inc. of Japan granting Spectral the exclusive development and commercial rights in the U.S. for Toraymyxin(TM), a therapeutic device for the treatment of sepsis that removes endotoxin from the bloodstream. Under the terms of the agreement, Spectral will seek FDA approval for Toraymyxin(TM) and intends to commercialize the product together with its Endotoxin Activity Assay (EAA(TM)), the only FDA cleared diagnostic for the measurement of endotoxin.

"The finalization of this agreement, on schedule, is an important milestone for Spectral and demonstrates the significant progress we have made on our path to delivering an effective treatment for severe sepsis in the United States. Toraymyxin(TM) has been used on more than 70,000 patients to date, primarily in Europe and Japan, for the treatment of severe sepsis caused by endotoxemia," said Dr. Paul Walker, President and CEO of Spectral. "Furthermore, together with our proprietary EAA(TM), the combination has demonstrated a significant reduction in the mortality of patients with severe sepsis compared to standard of care in European clinical trials. This innovative product has the potential to fulfill a severely unmet need for the approximately 100,000 patients that develop severe sepsis or septic shock in the U.S. each year."

Spectral plans to conduct a pre-Investigational Device Exemption (pre-IDE) meeting with the U.S. FDA this quarter as a first step towards gaining clearance for its clinical strategy, with the objective of initiating clinical trials in the latter half of 2009.

About Toray

Toray Industries, Inc. is a leading diversified chemicals corporate group that has been technology-focused since its foundation in 1926. The company's operations are underpinned by technological expertise in organic synthet
'/>"/>

SOURCE Spectral Diagnostics Inc.
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3

Related biology technology :

1. Spectral partner launches EAA(TM) Rapid Sepsis Diagnostic in Germany
2. US Patent and Trademark Office Allows CRis Patent Application for Spectral Imaging of Deep Tissue
3. CRi Announces Nuance 2, the Next-Generation Multispectral Imaging System for Brightfield and Fluorescent-Based Microscopy
4. Spectral announces data on the clinical utility of EAA(TM) to be presented at 12th Annual Critical Care for Endotoxemia Conference in Japan
5. Spectral appoints Anthony Bihl to Board of Directors
6. Spectral announces 2007 financial results
7. Spectral announces new findings on the effectiveness of EAA(TM)/Toraymyxin(TM) at the 28th International Symposium on Intensive Care and Emergency Medicine
8. Spectrals EAA(TM) to be used in Phase III study for a sepsis anti-endotoxin therapy
9. Spectral and Toray expand collaboration to include new geographic territories
10. Spectral announces presentation of data on improving sepsis patient management with EAA(TM) and Toraymyxin(TM) combination
11. Spectral announces continuing support for the combination of EAA(TM) and anti-endotoxin therapeutics
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/21/2014)... scientists has observed tiny quantum vortices in cold droplets ... Science that the exotic vortices arrange themselves ... the first time that the quantum vortices, which have ... known as superfluid helium, have been detected in nanodroplets. ... Vilesov of the University of Southern California, one of ...
(Date:8/21/2014)... 21, 2014 ... announced the addition of the  "Global Hormone ... offering.       (Logo: http://photos.prnewswire.com/prnh/20130307/600769) ,Hormone ... is a means of replacing hormones that ... body. This type of therapy is usually ...
(Date:8/21/2014)... SPRING, N.Y. , Aug. 21, 2014 /PRNewswire/ ... the launch of their Nutraceutical "TELO-20 for Dogs" ... and only Telomere-lengthening supplement in the world for ... ends of every chromosome in the body. A ... world,s leading experts in Telomere Science and Aging, ...
(Date:8/21/2014)... , Aug. 21, 2014  Decision Resources Group ... Brazil and Mexico ... of several newly approved agents, the anticipated label ... and the launch of emerging biologics will substantially ... particular, the emerging IL-5 inhibitors will introduce a ...
Breaking Biology Technology:Scientists observe quantum vortices in cold helium droplets 2Global Hormone Replacement Therapy Market 2014-2018: Key Vendors are Actavis, Bayer, Merck & Co, Novartis and Novo Nordisk 2Telomere Biosciences Announces: TELO-20 for Dogs, the World's First Telomere-Lengthening Supplement for Dogs, to Promote Healthy Aging and Longevity 2Telomere Biosciences Announces: TELO-20 for Dogs, the World's First Telomere-Lengthening Supplement for Dogs, to Promote Healthy Aging and Longevity 3Asthma Agents Currently Face a Suboptimal Coverage Environment in Brazil and Mexico, and as the Treatment Armamentarium Expands, Competitiveness Will Further Intensify 2Asthma Agents Currently Face a Suboptimal Coverage Environment in Brazil and Mexico, and as the Treatment Armamentarium Expands, Competitiveness Will Further Intensify 3
... RDEA ) today announced that preclinical data will be presented on,the ... (DDW) 2008 in San Diego., The oral presentation details ... 20, 2008 at 3:30 p.m. Pacific Time ... Ameliorates Murine Colitis ...
... ST. LOUIS, May 14 Sigma-Aldrich (Nasdaq:,SIAL) announced today ... Hogan will retire at a date to be determined ... the Company early this,year of his desire to retire ... transitioned. The Company has initiated a search to,identify a ...
... LLC,MDAC is proud to announce that it has engaged ... success optimizing investments in,the medical device market as board ... Tony Dimun, CEO of Nascent Enterprises, LLC, formerly of ... PhD, Chairman and CEO of SomaLogic Inc., and formerly ...
Cached Biology Technology:Ardea Biosciences to Present Data on Lead MEK Inhibitor, RDEA119, at Digestive Disease Week 2008 2Sigma-Aldrich (Nasdaq: SIAL) CAO & CFO Hogan Plans to Retire; Search for Successor Underway 2MEDdevice Acquisition Co., LLC Announces Board Members and Advisors 2
(Date:8/21/2014)... BATON ROUGE In a finding that has implications ... and planets elsewhere in the solar system, LSU Associate ... funded by the National Science Foundation, or NSF, this ... sediments of a lake that lies 800 meters (2600 ... sheet support "viable microbial ecosystems.", Given that more than ...
(Date:8/21/2014)... the water window? It consists of radiations in the ... by the water in biological tissues. New theoretical findings ... within the water window. These could be the basis ... of the biological samples or to be used in ... physical mechanism needed to efficiently generate the harmonic radiationswhich ...
(Date:8/21/2014)... in the journal Carcinogenesis by researchers at ... the protein adenomatous polyposis coli (APC) in suppressing colorectal ... the U.S. , Lead author Kristi Neufeld, associate professor ... the Cancer Biology program at the KU Cancer Center, ... to understand the various activities of APC, a protein ...
Breaking Biology News(10 mins):800 meters beneath Antarctic ice sheet, subglacial lake holds viable microbial ecosystems 2800 meters beneath Antarctic ice sheet, subglacial lake holds viable microbial ecosystems 3800 meters beneath Antarctic ice sheet, subglacial lake holds viable microbial ecosystems 4Water window imaging opportunity 2Research offers insight into cellular biology of colorectal cancer 2Research offers insight into cellular biology of colorectal cancer 3
... A new genetic resource from an international research consortium ... and treatments for a wide range of human diseases. ... will increase the likelihood that experiments conducted in mice ... in the CC have 90 percent of the genetic ...
... LAKE CITY -- Climate change spells trouble for many ... forests and relatively small areas and the damage ... disease and competition among species. That is among ... studies relevant to the topic. The review was scheduled ...
... it matter whether long periods of hot weather, such as ... in June or July, August or September? Scientists studying ... when such events happen makes a big difference. Based ... Science Foundation (NSF) Konza Prairie Long-Term Ecological Research (LTER) site ...
Cached Biology News:New mouse collaborative cross resource promises new cures and treatments for diseases 2Climate change threatens tropical birds 2Climate change threatens tropical birds 3Climate change threatens tropical birds 4Climate change threatens tropical birds 5Time of year important in projections of climate change effects on ecosystems 2
...
Collected from sexually matured, mixed breed, mixed sex guinea pigs....
Antibody specific for phosphorylattion of histone H3 that occurs during mitosis. Rabbit polyclonal serum. Antigen: Synthetic peptides derived from histone H3, phosphorylated at serines 10 or 28...
DTT, 25g...
Biology Products: