Wisconsin Technology Council: Isomark ‘Canary’ device proves effective in multi-center study, publication says
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This infection monitoring technology, known as the CanaryTM, was developed in an effort to achieve early non-invasive detection of infections. The Canary measures isotopic biomarkers in carbon dioxide samples exhaled through the breath. The changes in these metabolic outputs can indicate the body’s response to the first signs of infection, known as the acute phase response.
This non-invasive device is utilized by either a connection to an already existing ventilator (for mechanically ventilated patients) or by having subjects breathe directly into a sample bag or collection mask. Both methods of collection will be tested for safety and efficacy in future trials.
Isomark will join about 60 other emerging companies from Wisconsin March 18 at the Wisconsin Tech Summit in Green Bay.
Infections continue to be the leading cause of illness and death in intensive care unit (ICU) patients. Current practices, accurate as they may be, take a long time in determining confirmation of infection. That may result in more patient complications, longer hospital stays and can drive up hospital costs for the patient.
A multi-center study, conducted at four clinical sites including the University of Wisconsin-Madison Hospital and Clinics, recently tested the Isomark technology to aid in distinguishing non-infectious inflammation from infection. Clinical researchers demonstrated that this non-invasive monitoring system has the potential to provide clinicians a way to quickly and safely measure infection biomarkers in the body.
“Earlier diagnosis can lead to earlier treatment plans and an overall higher positive treatment outcome. Additionally, earlier detection can result in shorter hospital stays and lower costs to the patient,” said Joe Kremer, Isomark’s chief executive officer. “Many researchers and clinicians believe the ability to deliver early treatment will significantly change the current clinical dynamic of reacting defensively to infections. An early warning of a developing infection will enable a more proactive approach with the initiation of treatment very early in the infection’s development stage.”
Distributed by the Tech Council News Service.
About the company:
Isomark’s Canary™ monitoring system uses patented, breath-monitoring technology that has been demonstrated in clinical studies to detect infections up to two days before standard methods. Isomark’s technology is exclusively licensed from the Wisconsin Alumni Research Foundation, with the most recent patent being issued in August 2013. The initial target market for Isomark is the intensive care unit, where hospital-acquired infections such as sepsis and ventilator-associated pneumonia are common problems. Isomark has previously been awarded $2.5 million in Small Business Innovation Research grants by the National Institutes of Health. The identified regulatory pathway for the U.S. Food and Drug Administration is a de novo 510k, multiple-center trial with up to 400 patients. Isomark Canary™ has been assigned to the Division of Microbiology Devices in the Office of In Vitro Diagnostics and Radiological Health (OIR) at the FDA.
Learn more about the Isomark LLC: