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 […]
Spectral Medical Inc
Spectral Medical’s Toraymyxin fails pivotal trial
A clinical trial of the Toraymyxin anti-sepsis device made by Spectral Medical (TSX:EDT) failed to meet its primary endpoint, sending share prices on a -81.1% plunge today. Toronto-based Spectral developed a stand-alone pump, the Toraymyxin device, designed for use with an assay to identify endotoxin levels. The system aims to use a 2-column hemoperfusion to remove septic […]
Spectral Medical takes a mystery dive, recovers
Shares in Spectral Medical (TSX:EDT) took a mystery dive yesterday, plunging -33.9% before recovering today and leaving even the sepsis treatment maker shaking its head. Toronto-based Spectral, which earlier this week said it plans to file its final pre-market approval module with the FDA for its Toraymyxin device by the end of the year, said today that “its management and […]
Spectral Medical eyes final PMA bid by year-end for Toraymyxin anti-sepsis device
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 […]
Leading the battle against sepsis: A MassDevice podcast with Spectral Medical CEO Paul Walker
Spectral Medical CEO Dr. Paul Walker has been focused on finding a solution to identify and treat sepsis, and specifically endotoxins that are known to trigger it, for over 20 years. Sepsis affects approximately 1 million patients in the U.S. each year, and even more worldwide – and treating the deadly condition has proved to […]
Spectral Medical wins compassionate use exemption for Toramyxicin
Spectral Medical said today it won compassionate use expanded access from the FDA for its Toraymyxin blood treatment device designed for removing endotoxins from patient’s blood. The Toraymyxin is an investigational therapeutic hemoperfusion device designed to treat patients in septic shock with elevated levels of endotoxins. “As we move to complete our PMA submission for Toraymyxin with […]
Spectral Medical touts PMA acceptance for sepsis treatment
Spectral Medical today announced the FDA has reviewed and accepted 1 of 2 pre-clinical modules in its premarket approval application for its Toraymyxin device designed to remove endotoxins from the bloodstream. The Toraymyxin is an investigational therapeutic hemoperfusion device designed to treat patients in septic shock with elevated levels of endotoxins. The Canadian company touted study […]
Spectral Medical closes over-allotment, brings in $10.5m in round
Spectral Medical said today it closed an over-allotment on its most recent round of financing, selling an additional 806,804 shares at 70¢ per share to lift the round to $10.5 million Toronto-based Spectral makes a system designed to diagnose and remove endotoxin from the bloodstream. The offering was underwritten by a syndicate led by Cormark […]
Spectral Medical looks to raise $10m
Spectral Medical said it inked a deal for a $10 million stock sale it plans to use to fund a clinical trial. Toronto-based Spectral makes a system designed to diagnose and remove endotoxin from the bloodstream. The offering involves the purchase of 14.3 million shares at 70¢ apiece by a consortium of underwriters, who plan […]
Spectral Medical inks distribution deal with Fresenius
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 […]
