Spectral Medical ’ s Toraymyxin fails pivotal trial

A clinical trial of the Toraymyxin anti-sepsis device made by Spectral Medical (TSX:EDT) failed to meet its primary endpoint, sending share prices on a -81.1% plunge today. Toronto-based Spectral developed a stand-alone pump, the Toraymyxin device, designed for use with an assay to identify endotoxin levels. The system aims to use a 2-column hemoperfusion to remove septic toxins from the bloodstream; Spectral Medical licenses the technology for the North American market from Japan’s Toray Industries (TYO:3402). The company, which has said it plans to file its final pre-market approval module with the FDA for Toraymyxin by the end of the year, said its 446-patient Euphrates trial missed the primary endpoint of 28-day mortality compared with the standard of care. CEO Dr. Paul Walker told Reuters that the mortality reduction number took a hit from a smaller-than-expected endotoxin decrease. “We proved beyond doubt that endotoxin is bad and taking it out is good,” and Spectral will discuss next steps with the FDA, CEO Paul Walker told Reuters, noting that if the company can show that “more columns take out more endotoxin, then I think we can get approved.” Toray has been selling Toraymyxin in Japan for more than 20 years and in Canada since 2002, but trials have failed prove its efficacy. Walker said Spectral will likely need to run an additional, observational study of a 4-column system to prove the mortality benefit. That could push U.S. app...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Hospital Care Wall Street Beat Spectral Medical Inc Source Type: news