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 the FDA later this year, physicians in our clinical trial locations can now have immediate access to a therapy that has been used on more than 150,000 patients outside of North America for more than a decade. Prior clinical research has demonstrated that removing endotoxin from the blood with Toraymyxin can result in positive patient outcomes and a reduction in mortality,” CEO Dr. Paul Walker said in a press release.
With the new clearance, patients at 29 U.S. hospitals will be eligible for treatment with the device, as long as the meet appropriate clinical criteria, including septic shock, multiple organ failure and elevated levels of endotoxin in the blood.
A similar program is planned for 12 hospitals in Canada which are engaged in a clinical trial of the device.
Earlier this month, Spectral Medical said the FDA reviewed and accepted 1 of 2 pre-clinical modules in its premarket approval application for its Toraymyxin device.
The Canadian company touted study data indicating that the device can remove up to 90% of an endotoxemic patient’s circulating endotoxins when administered within 24 hours.
As part of the modular PMA filing, Spectral said it will submit 4 modules of documentation for staged review by the FDA, including pre-clinical information, a description of the manufacturing process and clinical data. Three modules have already been submitted, with 1 pre-clinical module having already been reviewed and expected.
The 4th and final module, containing data from its pivotal Euphrates trial, is slated to be submitted by the end of 2016.
