Spectral Medical (TSX:EDT) said this month it won FDA 510(k) clearance for its Spectral Apheresis Machine designed for use in continuous renal replacement therapy and therapeutic plasma exchange.
The SAM device was developed to support commercialization of the company’s Toraymyxin, or PMX therapy, to enable intensive care units to be able to safely and efficiently deliver PMX treatments to patients undergoing septic shock.
The Toronto-based company said it initially sought FDA clearance for CRRT applications, but that the system has been designed as an open platform hemoperfusion delivery device and that it will be seeking further 510(k) clearance for that purpose once there is an approved hemoperfusion cartridge available in the US.
“The 510(k) clearance for SAM has been achieved through extensive collaboration between the project management team at Spectral and the development team at Infomed SA in Geneva, Switzerland. We believe that SAM represents a landmark innovation in the CRRT field and we now plan to explore opportunities for the clinical deployment of this innovative patented technology, beginning initially with further testing of the instrumentation in hospital settings,” sales & marketing VP Dr. Gualtiero Guadagni said in a press release.
The company said it has also submitted an application seeking approval for the device from Health Canada, with an expected response during the first half of 2018.
Last October, a clinical trial of Spectral’s Toraymyxin anti-sepsis device failed to meet its primary endpoint, sending share prices on a -81.1% plunge.
