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 data indicating that the device can remove up to 90% of an endotoxemic patient’s circulating endotoxins when administered within 24 hours.
“As we look toward completing our submission to the FDA this year, the agency’s acceptance of this module is a significant milestone. This particular section contains key pre-clinical data on the use of Toraymyxin for patients with septic shock, including the device’s engineering and bench testing; sterilization and shelf life; packaging and transport details. We are encouraged that the FDA accepted this data, which is critical to our submission, as we continue to advance our regulatory filing with the goal of bringing this treatment to people in need,” CEO Dr. Paul Walker said in a press release.
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.
In February, Spectral Medical said 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
The offering was underwritten by a syndicate led by Cormark Securities and joined by Mackie Research Capital Corporation, according to a press release.
Proceeds from the offering will be used to complete the company’s Euphrates clinical trial and for the commercialization of the company’s PMX device, as well as for general corporate purposes.
The Euphrates trial is expected to enroll roughly 446 patients, with a primary endpoint of 28-day mortality. It’s designed to compare the standard of care with treatment using the Toraymyxin device.
