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| ZIO patch--Courtesy iRhythm |
After closing a $17 million Series E financing, iRhythm Technologies CEO Kevin King isn't slowing down. He has his eye on a CE mark in 2014 for the company's ZIO Service, a move that would greatly expand the market and revenue potential for the arrhythmia diagnostic device.
ZIO has had FDA clearance since 2009, and it launched commercially in the U.S. in 2011. The new funding round will help, in part, to bring iRhythm toward international expansion by building up its sales force. The cash infusion will also fuel additional clinical trials, actions that will help buttress ZIO in the marketplace as executives pursue an expanded reach for their signature product.
"We're really focused this point on a very long runway and value creation," King told FierceDiagnostics in an interview during which he also revealed the CE mark timeframe. "The business is now at the point where it is recognized as a new standard for long-term continuous monitoring in a market that is very large."
For years, the Holter monitor--which is worn over the neck, like a necklace, connected to the chest via wires and conductive patches--has been the gold standard for arrhythmia monitoring. Companies that produce event recorders, mobile outpatient cardiac telemetry, and internal loop recorders also compete in this space, but iRhythm frames these as cumbersome to use, expensive, or limited in their ability to capture enough heartbeat data for a definitive diagnosis.
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| iRhythm CEO Kevin King |
The ZIO Service provides long-term continuous monitoring for patients with suspected heart arrhythmias by way of a water-resistant patch that captures and analyzes heart data, an advance that increases the ability to capture more data and also simplifies how it is done. Earlier this year, ZIO won coverage from Aetna, the third-biggest private health insurer in the U.S. Medicare also provides coverage as well as a number of public and other private plans, King noted.
"Cumulatively, we estimate we have coverage with 200 million individuals in the U.S.," King said.
To date, San Francisco-based iRhythm has conducted 6 postapproval studies that covered about 28,000 patients in all, comparing the use of ZIO to traditional standards of care such as the Holter monitor. Further trials will help to build further evidence as to ZIO's viability in a variety of new care settings, King said, including emergency departments, postprocedural monitoring, and during electrophysiology procedures.
With an eye on a CE mark for ZIO sometime in 2014, King said that iRhythm is "now eyeing international markets with strong interest."
King declined to disclose revenue and whether iRhythm is profitable yet. He noted, however, that iRhythm has been used medically with more than 250,000 patients. Commercial insurance companies generally reimburse the ZIO service at $500 per patient, depending on the payer, the company said.
Novo A/S led iRhythm's Series E, which also included previous investor Norwest Venture Partners. To date, the company has raised about $85 million since its 2006 launch.
- read FMD's initial story on iRhythm's funding news