Canada's Spectral hoping to win US approval for sepsis treatment
By Natalie Grover
July 13 (Reuters) - A small Canadian drugmaker is in the final stages of testing technology designed to treat sepsis, the surprisingly common condition that killed boxing legend Muhammad Ali.
If data from late-stage trial is positive, Spectral Medical Inc thinks it can win approval from the U.S. Food and Drug Administration as early as next year.
The technology has been in use in Japan and parts of Europe for years but has never been approved for wide use in the United States because, in the view of the FDA, it has never been tested in trial large enough to prove its effectiveness and safety.
Sepsis, derived from the Greek word for putrefaction, occurs when the immune system goes into overdrive to fight infection or bacterial toxins, triggering a cascade of physiological changes that can lead to multiple organ failure.
The leading cause of hospitalizations in the United States, it can result from a simple cut, routine surgery or infections associated with chronic disease - Parkinson's, in Ali's case.
Sepsis costs the U.S. healthcare system about $20 billion a year, according to the Sepsis Alliance, a San Diego-based patient advocacy organization.
Infants, the elderly and those with weakened immune systems are most at risk.
In extreme cases, a dramatic drop in blood pressure can lead to life-threatening septic shock. Continued...