Here’s where the rubber hits the road for Leon Amariglio, Doron Harlev, and the startup they co-founded, Rhythmia Medical. After spending years to create an advanced system for mapping hearts during cardiac procedures, Rhythmia plans to test its technology in humans for the first time this year, Amariglio tells Xconomy.
The Burlington, MA-based company’s investors will soon get to see whether the $12 million they’ve pumped into Rhythmia since its launch in 2004 was worth the gamble. Norwich Ventures, of Waltham, MA, and Wyomissing, PA, has the most riding on Rhythmia among the startup’s investors, most of whom are either individual doctors, or business experts like MIT entrepreneurship professor Ed Roberts. The firm plans to begin a clinical trial of its catheter-based system in Europe in the coming months, testing the technology in fewer than 100 patients who are undergoing procedures to correct their irregular heartbeats, according to the firm’s co-CEO, Amariglio.
When asked how he felt about entering human studies, Amariglio said, “It’s exciting because it’s real, and it’s great to finally to be here.”
Rhythmia is attempting to improve the speed and resolution of the catheter-based systems that cardiology specialists called electrophysiologists use to get a three-dimensional view of the heart and the location of tissue responsible for irregular heartbeats, or arrhythmias. These systems are key to pinpointing the problematic heart tissues before they are destroyed to treat a patient’s arrhythmia. But existing technologies often require electrophysiologists to spend two to three hours to get a clear picture of the heart and where the culpable tissue resides.
Amariglio and Harlev, the other co-CEO of Rhythmia, decided to start their company without having any technology to solve this problem. (They met in the early half of the last decade while Amariglio was a student at 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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