Startup with device for early sepsis detection hopes for new CEO and 2014 market launch

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Isomark, a Wisconsin, Madison-based medical device company, was founded back in 2005 with a goal to commercialize a technology developed at the University of Wisconsin-Madison that could detect blood infections early.

But lacking a focus on what market to pursue meant the company didn’t really start to raise money until 2010. That occurred shortly before Dave Kruse, currently interim CEO, came on board when the company decided it should focus on adults and children who are in the hospital and breathing with the assistance of a ventilator. Kruse first raised $300,000 in an angel round followed by $130,000 in a bridge round.

Now with a clinical trial complete, Isomark is hoping to hire a new CEO by the end of the year and raise a little over $1 million, all with the goal of launching the sepsis detection device in late 2014. Severe sepsis is estimated to affect 750,000 people annually in the U.S. and the infection has a 28.6 percent mortality rate. It kills more people than stroke and pneumonia.

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So how the does the product spot sepsis early on? Board member and strategic adviser Neil Holland explains that unlike conventional methods of detection that measure heart rate, blood pressure and temperature, Isomark’s device actually measures two isotopes of carbon found in a person’s breath.

When the ventilated patient breathes out, the breath is captured in a bag and measured to determine the ratio between carbon 12 and carbon 13.

“When you have an infection in your body, the body actually preferentially uses carbon 13 in the metabolism associated with your infection,” explained Holland in a recent interview. “That was a very key finding that the University of Wisconsin scientists identified [in the early 1990s]. That finding causes the ratio between carbon 12 and carbon 13 to change very very slightly. ”

The patient’s sample goes into a spectrometer which¬†uses infrared lasers to measure the amount of carbon 12 and carbon 13 in the carbon dioxide in the breath.

“So if you have a very sensitive instrument that can measure both carbon 12 and carbon 13, you can detect changes in the ratio … that occur when the body is metabolizing in a certain way that is specifically associated with an infection, he said.

The clinical trial of 33 patients showed that Isomarks’ device could detect sepsis, in one case 48 hours before and in another case 12 hours earlier than conventional methods. These two patients became infected while they were being monitored, Kruse and Holland said.

The breath biomarker devised by Isomark is more reliable than heart rate and blood pressure because in many cases critically ill people on ventilators may also be trauma patients.

“One of the problems that clinicians today face in seeing the onset of infection is that often … vital signs [of sick people] are moving around for other reasons other than infection, Holland said. “Often an infection is masked by trauma. Also if they are on steroids they can have ¬†their infections masked by other blood-based biomarkers. So one of the advantages our technology has is that it can see through those other fluctuating markers. We can not only detect earlier, we can give a more clear indication of an onset of an infection.”

Holland said there is no medical device per se that is currently available that helps to detect sepsis, while Kruse, interim CEO, believes a future partnership with a company like Covidien or GE Healthcare.

For now the task is to get a new round of funding and a new CEO. Consultant Joe Kremer of Kremer Ventures, the consulting firm helping to get a new CEO and sell the startup’s story to potential investors, said that Isomark has achieved proof of concept and done a clinical trial all for $430,000.

“The story is that the company has been very judicious with its money,” Kremer said. “It has really researched the technology, proven it out with its pre-clinical trial and then done it so on very few dollars.”

[Photo Credit: Blood poisoning from Big Stock Photo

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Arundhati Parmar

By Arundhati Parmar

Arundhati Parmar is the Medical Devices Reporter at MedCity News. She has covered medical technology since 2008 and specialized in business journalism since 2001. Parmar has three degrees from three continents - a Bachelor of Arts in English from Jadavpur University, Kolkata, India; a Masters in English Literature from the University of Sydney, Australia and a Masters in Journalism from Northwestern University in Chicago. She has sworn never to enter a classroom again.
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