The trial was completed in June of this year.
In addition, the Company announced that the United States Food and Drug Administration ("FDA") has completed its initial review of the third module of the Company's PMA submission and the 510k submission for the Company's standalone pump.
The Company is in the process of responding to the FDA's initial queries and is on track to file the final PMA module with clinical data in the fourth quarter of this year.
"We are eagerly awaiting the results of our clinical trial, which was designed to show a significant reduction in the mortality of patients with endotoxemic septic shock. Pending satisfactory results, we would expect to proceed with completion of our regulatory filings in the fourth quarter as we seek approval for our targeted treatment which is guided by a diagnostic", said Dr. Paul Walker, President and CEO of Spectral.
"If approved, this treatment could be available to patients by as early as the first half of 2017", added Dr. Walker.
Spectral is a Phase III company seeking U.S. FDA approval for its unique product for the treatment of patients with septic shock, Toraymyxin (PMX).
PMX is a therapeutic hemoperfusion device that removes endotoxin, which can cause sepsis, from the bloodstream and is directed by the Company's Endotoxin Activity Assay (EAA™), the only FDA cleared diagnostic for the risk of developing sepsis.
PMX has been approved for therapeutic use in Japan and Europe, and has been used safely and effectively on more than 150,000 patients to date.
Approximately 350,000 patients are diagnosed with severe sepsis and septic shock in North America each year, representing a greater than $3 billion market opportunity for Spectral.
