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Isomark LLC awarded $1.7 million NIH grant; money will speed ‘Canary’ development efforts

MADISON – The National Institutes of Health has awarded Isomark LLC a $1.7 million grant to help develop and bring to market the Isomark Canary™, a non-invasive breath analyzer. The device is intended to provide early warnings of potentially deadly patient infections.

The federal Small Business Innovation Research grant is a two-year “FastTrack” award that will help Isomark hire two employees – a biomedical engineer and a quality assurance manager.  The grant also augments other base funding for the company, primarily from private investors, as it moves toward a federal Food and Drug Administration trial of the Canary.

Earlier this year, Isomark announced a $150,000 investment by the Wisconsin Alumni Research Foundation in the company as well results of a human study that demonstrated a link between breath carbon isotope “delta values” and inflammatory acute phase response. The results differentiated between healthy and infected patients.

The Isomark Canary uses patented technology and methods to detect infections early by monitoring for the changes in metabolism. Specifically Isomark’s biomarkers signal the onset of the acute phase response, the body’s early defense mechanism against infections.  The acute phase response is a specific shift in the way the body metabolizes energy and begins to build immune proteins.

By detecting the acute phase response, Isomark is able to detect the presence of an infection soon after it begins, helping to guide clinicians on which patients need expensive diagnostic tests, which do not and enabling earlier treatment before complications – such as sepsis – set in. Early treatment of infections results in improved results at reduced costs.

“We’re excited by the NIH grant,” said Joe Kremer, chief executive officer of Isomark.  “The funding not only helps us to continue to develop and improve the Canary but also helps us with our regulatory pathway through the FDA. It is also significant to receive a ‘nod’ of validation from the experts at the NIH; we value their continued support of this project.”

Health care-associated infections cost between $35 billion and $88 billion per year in the United States alone. In 2008, Medicare stopped reimbursing for additional costs related to treating hospital-acquired infections and has begun to issue financial penalties partly based on hospital infection rates. Along with a movement toward case-based reimbursement, these regulations are creating a strong financial incentive for hospitals and other health-care institutions.

About the company:

Isomark’s Canary™ monitoring system uses patented, breath-monitoring technology 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 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.  Isomark Canary™ has been assigned to the 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:

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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