Devices & Diagnostics

CardiOx targets $3.5M series C, regulatory clearance by year’s end

CardiOx is hoping to close a $3.5 million series C round of investment that would […]

CardiOx is hoping to close a $3.5 million series C round of investment that would go toward commercializing its noninvasive test for holes in the heart.

The Columbus, Ohio-area company is also looking to obtain European and U.S. regulatory clearance by the end of the year, with the European Union’s CE Mark expected to come this summer, CEO Larry 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.

The company was incorporated in 2006 and has raised $5.5 million in venture money and about $1.25 million in nondilutive grants. Investors include Cleveland-based Early Stage Partners and North Coast Angel Fund, plus Columbus-based Reservoir Partners.

CardiOx recently picked up another investor when it closed on $250,000 from Cleveland-based Glengary. “We invested in CardiOx because of our confidence in the management, the strength of the existing investor group and the uniqueness and value of the product,” said Steve Haynes, a managing partner with Glengary.

Glengary would consider investing in CardiOx’s C round at a multiple of its original investment, Haynes said.

CardiOx is wrapping up clinical trials that will generate data for the company’s 510(k) application for U.S. Food and Drug Administration clearance. Ideally, the company would like to obtain market clearance in a time frame that would allow it to launch its device at a key industry conference in November, called Transcatheter Cardiovascular Therapeutics, or TCT2011, Heaton said.

The company will initially focus its test on the stroke market, which Heaton estimates at $400 million annually in the U.S. and twice that worldwide.

Heaton estimates 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.

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