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 synthetic chemistry, polymer chemistry, and biochemistry. These innovative technologies have yielded "advanced materials" that Toray is now exploiting to provide customers with comprehensive solutions through Fibers and Textiles, Plastics and Chemicals, IT-related Products, Carbon Fiber Composite Materials, Environment and Engineering, Life Science and Other Business divisions. In FY2008, Toray had consolidated sales of 1,650 billion yen (approx $15 billion US), and over 33,000 employees worldwide. For further information, please visit www.toray.co.jp.

About Spectral Diagnostics

Spectral is a developer of innovative technologies for comprehensive disease management. Spectral's lead product is its EAA(TM) Endotoxin Activity Assay, the only FDA approved diagnostic for the measurement of endotoxin. Spectral technologies provide accurate and timely information to clinicians enabling the early initiation of appropriate and targeted therapy. Spectral is listed on TSX under the symbol SDI.

Forward-looking statement

Information in this news release that is not current or historical factual information may constitute forward-looking information within the meaning of securities laws. Implicit in this information, particularly in respect of the future outlook of Spectral and anticipated events or results, are assumptions based on beliefs of Spectral's senior management as well as information currently available to it. While these assumptions were considered reasonable by Spectral at the time of preparation, they may prove to be incorrect. Readers are cautioned that actual results are subject to a number of risks and uncertainties, including the availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, the ability of Spectral to take advantage of business opportunities in the biomedical industry, the granting of necessary approvals by regulatory authorities as well as general economic, market and business conditions, and could differ materially from what is currently expected.

     The TSX has not reviewed and does not accept responsibility for the
                   adequacy or accuracy of this statement.


'/>"/>
SOURCE Spectral Diagnostics Inc.
Copyright©2009 PR Newswire.
All rights reserved

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:4/21/2017)... ... 2017 , ... Frederick Innovative Technology Center, Inc. (FITCI), a ... technology start-ups, is hosting “Celebration Friday” (a festive gathering highlighting client success stories) ... and networking at 3:30 p.m. at FITCI’s 4539 Metropolitan Court location, off English ...
(Date:4/20/2017)... ... ... USDM Life Sciences , the leading risk management, technological innovation and ... announce Holger Braemer as Vice President of its Europe division and Managing ... , Braemer is an integral part of USDM’s expansion of services and solutions for ...
(Date:4/20/2017)... ... April 20, 2017 , ... Parallel6™ , the leader in ... today that they were named one of the 2017 Top 10 eClinical Trial ... in the pharmaceutical industry. , “We take pride in honoring Parallel6 as one of ...
(Date:4/19/2017)... ... 2017 , ... The Vibrating Orifice Aerosol Generator (VOAG) was ... droplets of known diameters for research applications such as for calibrating droplet measuring ... monodisperse droplets. , The VOAG requires forcing liquid out of an orifice ...
Breaking Biology Technology:
(Date:3/24/2017)... -- The Controller General of Immigration from Maldives Mr. ... have received the prestigious international IAIR Award for the most innovative high ... ... Maldives Immigration Controller ... (small picture on the right) have received the IAIR award for the ...
(Date:3/22/2017)... Lithuania , March 21, 2017   ... and object recognition technologies, today announced the release ... kit (SDK), which provides improved facial recognition using ... cameras on a single computer. The new version ... to improve accuracy, and it utilizes a Graphing ...
(Date:3/20/2017)... Pa. , March 20, 2017 PMD ... 2.0 personal spirometer and Wellness Management System (WMS), a ... Founded in 2010, PMD Healthcare is a Medical ... with a mission dedicated to creating innovative solutions that ... life. With that intent focus, PMD developed the first ...
Breaking Biology News(10 mins):