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Harvard Business School and Harlev was studying at the MIT Sloan School of Management.) However, they talked to enough physicians to learn that there was strong demand for systems that could shorten the heart-mapping portion of cardiac ablation procedures. One reason is that electrophysiologists are in short supply. Also, reducing the duration of the operations would allow physicians to perform more of them, a big plus for patients on waiting lists to get the ablations done, Amariglio says.
Rhythmia’s diagnostic catheter captures electrical signals from each heartbeat. On the back end of the system, the firm’s software processes the signals from the catheter to form a 3-D view of the heart. By calculating the timing of the signals moving through the heart, the software pinpoints the tissue responsible for the irregular heartbeats, according to Amariglio. The company has designed the end of its catheter with many more electrodes (64) than competing devices use (closer to four) to capture more electrical signals from the heart. Also, its algorithms rapidly process the data, providing a picture of the heart chambers in two to three minutes rather than the two to three hours it now takes, Amariglio says.
Still, the company faces significant hurdles before it can blow its competition out of the water. For one, the company needs to show that its system is safe and effective for human use to win FDA clearance, which the firm aims to get in 2011. Also, the company will need to convince healthcare providers to adopt its system over its competitors’ devices. Those competitors include industry giants such as St. Paul, MN-based St. Jude Medical (NYSE:STJ) and Johnson & Johnson (NYSE:JNJ), headquartered in New Brunswick, NJ.
Rhythmia plans to begin raising more capital to fund regulatory and commercialization efforts late this year or early next year, once the firm has results from its planned clinical trial, Amariglio says. Meanwhile, the market for the 22-employee firm’s system is large and growing larger. In 2009, market analysis firm iData Research reported that the diagnostic catheters for such procedures where the fastest growing segment of what in 2008 was $600 million U.S. market for cardiac electrophysiology and ablation devices, up 9.8 percent from 2007.
Yet Amariglio and Harlev have yet to write the final chapter of this story, one that could end in glorious victory or miserable defeat, depending on how well things progress from here. We’ll take the pulse of this company again after it completes its important clinical trial.
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