CardiOx Corp., which is developing a noninvasive method for detecting holes in the heart, has raised about $650,000 in a funding round.
The investment was sourced from three individuals and comes in the form of debt, warrants and options, according to a Securities & Exchange Commission filing.
The company hopes to raise as much as $2 million by the time the funding round is complete, according to the filing.
CardiOx is developing a non-invasive way to detect right-to-left heart shunts, a defect known as a patent foramen ovale or PFO that can lead to strokes, heart attacks and migraine headaches. CardiOx’s approach would combine an injection of dye with a diode sensor on the ear to determine the presence of a shunt. The device also can be used to verify that surgery succeeded in patching up the hole.
The procedure is less invasive than the current method of diagnosing shunts, in which a probe is pushed down the throat to the heart.
CEO Larry Heaton, a medical device industry veteran who started with the company in April, said the funding would be used to support operations through the submission of applications for approval from U.S. and European regulators, as well as the completion of clinical studies. The company plans to make its regulatory filings by the end of the year, he said.
CardiOx is targeting the second quarter of 2011 for European regulatory approval, known as the CE Mark, and third quarter for 510(k) approval from the Food & Drug Administration.
The company is looking to raise another round of investment, likely a few million dollars, to fund commercialization of its device, Heaton said.
So far, the company has raised about $4 million in venture money, primarily from Cleveland-based Early Stage Partners and Columbus, Ohio-based Reservoir Partners, Heaton said. In June, CardiOx and two other firms were awarded a nearly $1 million grant from Ohio’s Third Frontier program to help finalize designs and clinical protocols for the company’s product.
“We’ve got the whole clinical side figured out,” said Mike Bunker, a managing director with Early Stage Partners. A decade ago at device giant Medtronic Inc., Bunker led a $750 million global product launch in cardiac rhythm management and served on product development, strategy and clinical committees.
The diagnostic market for the three indications the company is pursuing — stroke, heart attacks and migraines — likely is more than $1 billion, Bunker said.
The topic of PFO made an appearance in the news recently, when the defect was linked to a stroke suffered by former Poison lead vocalist and reality TV star Bret Michaels. Between 20 and 25 percent of people suffer from PFOs, but most won’t experience any problems as a result, the Seattle Times reported.