Spectral Medicine submits modules to FDA for its PMA application for Toraymyxin a treatment for Sepsis.

Spectral Medical Inc. has announced that the FDA has reviewed and accepted one of the two pre-clinical modules in its PMA application for Toraymyxin, the Company's investigational therapeutic hemoperfusion device that removes endotoxin from the bloodstream. With acceptance of this module the Company remains on track to complete its full PMA submission by the end of 2016. Studies have shown that this medical device can remove up to 90 percent of an endotoxemic patient's circulating endotoxin when administered twice within a 24 hour period. As part of the modular PMA filing, Spectral will submit a total of four modules of documentation for review in stages by the FDA. Two of the modules include pre-clinical information, one describes the manufacturing process and the last module contains clinical data. Three modules have been submitted and one of the pre- clinical modules has now been fully reviewed and accepted. Spectral plans to submit its fourth and final module, comprising data from its pivotal EUPHRATES trial, by the end of 2016.

This therapy is aimed at those in septic shock who experience high levels of endotoxin in the blood.

Comment: Toraymyxin was developed by Toray Industries and was approved in Japan in 1993 and received CE Mark in 2002 where it is marketed in eight European countries by Fresenius Medical Care