Spectral Medical (TSX:EDT) said today that it plans to file its final pre-market approval module with the FDA for its sepsis treatment by the end of the year, after the impending release of primary endpoint data from a clinical trial.
The Toronto-based company developed a stand-alone pump, the Toraymyxin device, designed for use with an assay to identify endotoxin levels. The system aims to use hemoperfusion to remove septic toxins from the bloodstream.
Results on the primary endpoints of the roughly 446-patient Euphrates trial, completed in June, are slated to be released immediately after Sept. 30, Spectral Medical said. The primary endpoint is 28-day mortality, compared with the standard of care.
The FDA is done with the initial review of the 3 PMA modules and the 510(k) clearance application for the Toraymyxin device, the company said.
“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,” president & CEO Dr. Paul Walker said in prepared remarks. “If approved, this treatment could be available to patients by as early as the 1st half of 2017.”
In late June, Spectral won compassionate use expanded access from the FDA for the Toraymyxin blood treatment device. A financing round brought in $10.5 million in February.
