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WARF invests $150,000 in Isomark LLC; money will support patient study of ‘Canary’

MADISON – The Wisconsin Alumni Research Foundation has invested $150,000 in Isomark LLC, funding that will be used by the Madison-based firm to help support a 110-patient study of the company’s non-invasive “Canary” breath analyzer. The device is intended to provide early warnings of potentially deadly patient infections.

The WARF investment more than doubles $130,000 in private money raised by Isomark in recent months as part of its latest $750,000 funding round. The round will be used to support the study, which will take place at the UW Hospital and Clinics.

“Isomark is a ready example of technology developed at the UW-Madison with potential for saving and improving lives worldwide,” said Michael Falk, general counsel for WARF. “Our investment will help move the company to its next stage and to gather much-needed clinical data, which we expect will build upon investor and customer interest in the company.”

A previous study tracked 17 mechanically ventilated pediatric patients and differentiated between those who were healthy and those who were infected. It demonstrated a link between breath carbon isotope “delta values” and inflammatory acute phase response. The breath delta value can be thought of as “the temperature of the immune system,” and provides a biomarker for infections at the earliest moments.

That relationship may be critical in the early diagnosis of Systemic Inflammatory Response Syndrome. The onset of SIRS, which occurs in 82 percent of patients admitted to pediatric intensive care units, can lead to sepsis.

Sepsis, severe sepsis and septic shock are types of systemic infections caused by a micro-organism, such as bacteria or viruses, and may lead to organ dysfunction and death. Sepsis ranks as the most common cause of death of infants and children in the world.

“We’re excited to continue to build investor support for Isomark and to continue work on the milestones that we believe will allow ‘Canary’ to be safely and efficiently introduced to the market,” said Joe Kremer, CEO of Isomark.

The earlier pediatric study was published by the Royal Academy of Chemistry. It noted “the early detection of bacterial sepsis followed by immediate intervention is critical for successful outcomes to patient care. Current clinical methods are often unreliable in detecting early bacterial sepsis; accordingly, there is great interest in identifying laboratory methods for early detection of sepsis.”

In the United States alone, there were more than 47,000 cases of severe sepsis in children aged 19 or younger in 1999. Hospital mortality rate for those children was estimated at 9 percent for that year. The estimated annual total costs were $2.3 billion for pediatric patients in the United States alone for that year.

Overall, hospital-acquired infections cost the U.S. healthcare between $35 billion and $88 billion per year. In 2008, Medicare stopped reimbursing for the additional costs related to treating hospital-acquired infections in adults.

About the company:

Isomark’s Canary Breath Delta Value analyzer uses patented, breath-monitoring technology to detect infections up to 48 hours 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 a $500,000 Small Business Innovation Research grant 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 600 patients.

Learn more about the previous study:

This news release contains forward-looking statements. You can identify these statements by our use of words such as “may,” “expect,” “believe,” “anticipate,” “intend,” “could,” “estimate,” “continue,” “plans,” or their negatives or cognates. These statements are only estimates and predictions and are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Medical device development involves a high degree of risk.

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