Shares of Spectral Medical Inc. (TSX: EDT), a Toronto-based medical company developing treatments for sepsis and septic shock, skyrocketed 38.5 percent Tuesday morning following the company's announcement that the US Food and Drug Administration has approved an investigational device exemption (IDE) for Spectral's PMX cartridge in the treatment of COVID-19 patients with septic shock.
The approval gives formal recognition that PMX is safe and effective enough to treat patients that are similar to those in Spectral's "Tigris" clinical trial of PMX against septic shock.
“This immediately green lights our Tigris study centers which are already prepared and trained on PMX use, and our resources can be used to quickly bring on more hospitals," Spectral's vice president of clinical development, Debra Foster, said in the release. "We have been fielding unsolicited inbound inquiries from hospitals in North America concerning our therapy for the COVID-19 pandemic as it relates to septic shock, asking how we can help."
PMX is a product designed to remove endotoxin—a molecule that causes sepsis and intestinal endotoxemia—from the bloodstream. Endotoxins are the primary drivers of what's called cytokine storms, essentially an overreaction of the body's immune system that can arise as a potentially fatal complication for diseases like COVID-19. In fact, Spectral says, PMX has been used outside the US against H5N1 and H1N1 in the past and has "resulted in decreased dependency on ventilators," a serious issue in the current pandemic.
"This IDE approval will allow us to significantly help COVID-19 patients who experience multiple organ failure resulting in septic shock, and will ultimately help save lives," said Dr. Paul Walker, Spectral's CEO.
Since announcing the approval, shares of Spectral have increased 20 cents to 72 cents per share, at the time of writing.