Heart test-maker CardiOx has closed an $8 million series C round of investment that the company plans to use to begin U.S. and European commercialization.
The round was led by Michigan-based Lifeline Ventures, a new investor in Columbus, Ohio-based CardiOx, and included contributions from existing investors Early Stage Partners, Glengary and Reservoir Partners, CardiOx CEO Larry Heaton said.
CardiOx plans to file by the end of the year for both U.S. and European regulatory clearance of its heart test, Heaton said.
CardiOx is developing a noninvasive way to detect right-to-left heart shunts (a defect known as a patent foramen ovale or PFO), which in some people can lead to strokes, heart attacks and migraine headaches. CardiOx’s approach combines an injection of dye into a patient’s heart with sensors on the ear to determine the presence of a shunt. The device also can be used to verify that surgery succeeded in patching the hole.
Prior to the series C, CardiOx had raised about $5.5 million since its inception in 2006.
In addition to commercialization, the company plans to use the funding to step up manufacturing of its test and hire some employees. With CardiOx transitioning from product development to manufacturing, the company will need to hire several operations employees, Heaton said.
The company is wrapping up clinical trials of the test, Heaton said.
CardiOx will initially focus its test on the stroke market, which Heaton has estimated at $400 million annually in the U.S. and twice that worldwide.
Heaton estimated the wider market for the test — which would include other indications like migraines and sleep apnea — to be $1.1 billion annually in the U.S. and double that across the globe.
About 25 percent of the population is affected by PFO, but the vast majority show no symptoms associated with the condition. In patients who have stroke of unknown cause, the prevalence of PFO increases to about 40 percent, according to Cleveland Clinic.