Spectral Diagnostics gets FDA OK for US trial
Sepsis treatment developer Spectral Diagnostics Inc. said Tuesday it received regulatory approval to conduct a pivotal U.S. trial of its therapeutic device Toraymyxin.
The Toronto company said it received an investigational device exemption from the U.S. Food and Drug Administration, and it expects to start its trial in the first half of this year. The study will involve 360 patients at 15 sites throughout the United States.
Sepsis is blood poisoning caused by an aggressive bacterial infection that can cause major organ failure. Spectral said Toraymyxin removes endotoxin from the bloodstream in patients with septic shock.
Spectral CEO Paul Walker said in a statement from the company that more than 250,000 patients per year in the United States suffer from severe sepsis and are at high risk of dying.