Devices & Diagnostics

Cardiac mapping startup CardioInsight eyes U.S. market after European launch

Cardiac mapping company CardioInsight Technologies is turning some of its attention toward the U.S. market […]

Cardiac mapping company CardioInsight Technologies is turning some of its attention toward the U.S. market after its first-ever product installation last month in the United Kingdom.

But the Cleveland-based company will have to complete several key steps before U.S. commercialization can happen, CEO Steve Arless said.

Company officials are in discussions with the U.S. Food and Drug Administration aimed at planning a regulatory pathway for the company’s ECVUE electrocardiographic mapping system, which gathers electrical information about the heart from an electrode vest placed on a patient’s body and combines that information with images from a CT scan to produce 3-D maps of the electrical activity of the heart.

Because talks with the FDA are ongoing, Arless said it was premature to lay out specific plans or a time line. However, Arless said it is likely that CardioInsight will have to conduct a U.S. clinical study of the ECVUE device before filing for 510(k) regulatory clearance from the FDA.

Funding a clinical trial would likely involve CardioInsight raising a series C round of investment, Arless said, though he declined to put a dollar figure on it. CardioInsight closed a $6 million series B round about two years ago and has raised about $12 million in equity since its inception in 2006.

Like many U.S. medical device companies, CardioInsight commercialized its technology in Europe first. The first commercial installation of the ECVUE system was at St. Mary’s Hospital in London.

“It really is about the regulatory environment and the fact that, even for nonsignificant risk technology like ours, one is still able to get the CE Mark in a more rapid time period than regulatory approval here,” Arless said.

Unlike conventional methods, CardioInsight’s technology is noninvasive and provides beat-by-beat, whole-heart mapping. The technology — a sensor array on a vest and software to collect, analyze and combine its data with the CT image — is used to help diagnose and treat electrical abnormalities of the heart, such as those associated with arrhythmia and heart failure.

Leading companies in the cardiac mapping space include Johnson & Johnson subsidiary Biosense Webster and St. Jude Medical. Both of those companies, or other cardiac device players like Medtronic or Boston Scientific, would figure to be potential strategic acquirers of CardioInsight, though an acquisition could be more likely after CardioInsight’s technology is cleared by the FDA.

“The world is moving to less and less invasive technology, so one would think they’d have a look at this,” Arless said.

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