|Paul Walker, Spectral Medical CEO|
The FDA has accepted one of two preclinical modules from its PMA application for Toraymyxin from Spectral Medical, the company said. This news comes soon after Spectral snagged a solid CA$10 million (US$7.1 million) in funding this past January, specifically aimed at helping the company finalize its PMA submission for FDA approval.
This news keeps Spectral on track to complete a full PMA submission by the end of this year.
"As we look toward completing our submission to the FDA this year, the Agency's acceptance of this module is a significant milestone," said Dr. Paul Walker, president and CEO of Spectral, in the announcement.
The section that was accepted includes preclinical data on Toraymyxin use in patients with septic shock, "including the device's engineering and bench testing; sterilization and shelf life; packaging and transport details," Walker explained.
|Endotoxin Activity Assay (top) and Toraymyxin (bottom)--Courtesy of Spectral Medical|
This therapy is aimed at those in septic shock who experience high levels of endotoxin in the blood. Toraymyxin is a direct hemoperfusion adsorption column. Studies have found it can remove up to 90% of endotoxin when administered twice in a 24-hour period, the company noted.
The Toraymyxin hemoperfusion device works in tandem with Spectral's Endotoxin Activity Assay (EAA), which the company claims is the only FDA-cleared diagnostic regarding the risk of developing sepsis. the device is approved in Europe and Japan and has been used on 150,000 patients to date. According to Spectral, Toraymyxin could help up to 350,000 patients diagnosed with severe sepsis or septic shock in the U.S. each year.
For the PMA filing Spectral will submit four modules of documentation for FDA review. These will include two filings of preclinical information, one with info on manufacturing and one with clinical data. Three filings have been submitted with one preclinical module reviewed and accepted. The final module--data from the EUPHRATES trial--is set to be finalized by the end of this year.
The announcement also made note that the FDA accepted for review a 510(k) filing for a standalone pump for treatment delivery in the Intensive Care Unit (ICU).
Spectral isn't the only company with sights on sepsis devices. The Wyss Institute for Biologically Inspired Engineering at Harvard University launched a startup, Opsonix, to develop a sepsis device and raised a cool $8 million Series A toward that goal. French startup Inotrem raised its own $25 million to be used to develop and test its own sepsis treatment.
- here's the announcement