- Spectral Medical Inc. (EDT) announced that the U.S. Food and Drug Administration (FDA) has approved ten new clinical trial sites for the Tigris trial
- This approval would bring the total potential trial sites to 25 U.S. institutions
- The FDA determined Spectral provided sufficient data to support the expansion of its human clinical study
- The company has sought FDA approval for its study to examine Toraymyxin™ (PMX)
- Spectral Medical Inc. (EDT) is up 2.50 per cent trading at $0.41 per share as of 1:47 p.m. ET
Spectral Medical (EDT) announced that the U.S. Food and Drug Administration (FDA) has approved ten new clinical trial sites for the Tigris trial.
This approval would bring the total potential trial sites to 25 U.S. institutions. The company stated the FDA determined that it provided sufficient data to support the expansion of its human clinical study and that there are no further concerns that stop the ongoing study.
“Our goal is to add at least four additional clinical trial sites by the end of October 2022… having these additional sites active before flu season would be beneficial, given the prevalence of endotoxemic septic shock in these patients,” Dr. John Kellum, CMO of Spectral, said.
Spectral is a phase three company looking for U.S. FDA approval for its study to examine Toraymyxin™ (PMX) which treats patients with septic shock.
The company describes PMX as a therapeutic device that removes endotoxin, which can cause sepsis, from the bloodstream. The endotoxin activity assay guides the therapy, the only FDA-cleared diagnostic for the risk of developing sepsis.
“We believe this approval is further validation of our progress and builds upon PMX’s recent breakthrough device designation by the FDA, as well as our ongoing trial results, which continue to exceed expectations,” Chris Seto, CEO of Spectral, said.
Spectral Medical Inc. (EDT) is up 2.50 per cent trading at $0.41 per share as of 1:47 p.m. ET.