A Medical Device Daily
Spectral Diagnostics (Toronto) reported that it has signed a license agreement with Toray Industries (Tokyo) granting Spectral the exclusive development and commercial rights in the U.S. for Toraymyxin, a therapeutic device for the treatment of sepsis that removes endotoxin from the bloodstream.
Under terms of the agreement, Spectral will seek FDA approval for Toraymyxin and intends to commercialize the product together with its Endotoxin Activity Assay (EAA), the only FDA cleared diagnostic for the measurement of endotoxin.
"The finalization of this agreement, on schedule, is an important milestone for Spectral and demonstrates the significant progress we have made on our path to delivering an effective treatment for severe sepsis in the U.S.. Toraymyxin has been used on more than 70,000 patients to date, primarily in Europe and Japan, for the treatment of severe sepsis caused by endotoxemia," said Paul Walker, president/CEO of Spectral.
"Furthermore, together with our proprietary EAA, the combination has demonstrated a significant reduction in the mortality of patients with severe sepsis compared to standard of care in European clinical trials," he said. "This innovative product has the potential to fulfill a severely unmet need for the approximately 100,000 patients that develop severe sepsis or septic shock in the U.S. each year."
Spectral plans to conduct a pre-investigational device exemption meeting with the U.S. FDA this quarter as a first step toward gaining clearance for its clinical strategy, with the objective of initiating clinical trials in the latter half of 2009.