The services provided by Medwell under the amended agreement will no longer include clinical and regulatory consulting. This will reduce Medwell's costs to service this portion of the existing contract . The scope of services under the amended agreement will consist of corporate services, including strategic planning and public relations (including investor relations), in each case as required by Spectral to support it in its clinical and commercial operations, and is set at $400,000 per year plus expenses.
"We look forward to continuing with our commitment to Spectral through this agreement and to work together to maximize the commercial value of the Spectral opportunity," said Kevin Giese, President and CEO of Medwell Capital.
About Spectral Diagnostics
Spectral is a Phase III company seeking U.S. FDA approval for its lead theranostics product for the treatment of severe sepsis with septic shock. Toraymyxin is a therapeutic hemoperfusion device that removes endotoxin, which can cause sepsis, from the bloodstream. Directed by the Company's Endotoxin Activity Assay (EAA™), the only FDA cleared diagnostic for the risk of developing sepsis. Spectral's EUPHRATES trial is the world's second theranostics trial in the area of sepsis.
Toraymyxin has been approved for therapeutic use in Japan and Europe, and has been used safely and effectively in more than 100,000 patients to date. In March 2009, Spectral obtained the exclusive development and commercial rights in the U.S. for Toraymyxin, and in November 2010, signed an exclusive distribution agreement for this product in Canada. More than 250,000 patients are diagnosed with severe sepsis and septic shock in North America each year , representing a greater than $1 billion market opportunity for Spectral. Spectral is listed on the Toronto Stock Exchange under the symbol SDI, and on the OTQ QX under the symbol DIAGF.
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