Septic shock treatment developer Spectral Medical said today it inked a deal with Fresenius Medical Care to distribute its Endotoxin activity assay devices.
Fresenius will be the non-exclusive distributor of the device in Germany, Denmark, Sweden, Finland, Norway, Poland, Hungary and the Czech Republic, the company said.
“We are very pleased to have entered into this commercial relationship with Fresenius for our EAA diagnostic, which is key to the identification of patients in septic shock who are most likely to benefit from the PMX treatment. A positive outcome of our large clinical trial would clearly demonstrate the ability to address the huge market potential we see for the combined testing and treatment (PMX) protocol for patients with septic shock,” Spectral sales & marketing veep Dr. Gualtiero Guadagni said in a press release.
The EAA device will be sold initially in conjunction with Toraymyxin hemoperfusion cartridges designed to remove endotoxin from the bloodstream, Toronto-based Spectral Medical said.
The company is currently in a phase III registration trial of the device in anticipation of FDA approval of their PMX cartridge device.
The PMX cartridge has been approved in Japan and won CE Mark approval in the European Union, the company said.