iRhythm - 2014 Fierce 15

CEO: Kevin King
Based: San Francisco, CA
Founded: 2006

The scoop: Continuous monitoring via wearables is obviously trendy. And while it's still unclear whether a lot of the tech will actually translate into useful products, one company has an approved, reimbursed cardiac monitoring patch and system that's actually shown to improve physician diagnosis.

iRhythm's Zio service, which includes a patch and software analytics system, is being used to improve cardiac arrhythmia diagnosis and improve patient management compared to traditional approaches to ambulatory electrocardiogram monitoring.

What makes iRhythm Fierce: The patient wears the cardiac monitoring patch for up to 14 days. It's then returned to the company for analysis. Then the report is reviewed by a certified cardiac technician and the physician receives it.

ZIO patch--Courtesy of iRhythm

In a study published earlier this year in The American Journal of Medicine that was conducted by the Scripps Translational Science Institute, the Zio Service identified 57% more arrhythmias than the Holter monitor. A Holter monitor is typically worn for 24 to 48 hours and requires electrodes and wires that feed into a device. The participating physicians said that 90% of the time Zio provided a definitive diagnosis, compared with 64% for Holter monitoring. And 94% of patients reported preferring the Zio patch to Holter monitoring.

Since its 2011 launch, the Zio system has been used on more than 250,000 patients at almost 800 U.S. institutions. It's also widely reimbursed; its U.S. payers represent about 220 million covered lives.

The results haven't failed to impress; leading cardiologist Dr. Eric Topol has said it "may prove to be the new standard" for cardiac monitoring, while a blog post from NIH Director Dr. Francis Collins refers to these study results as "pretty amazing stuff."

"Overall, we think we've redefined or revolutionized how patients are diagnosed and treated. Almost all our clinical studies point to that. That includes atrial fibrillation. We are earlier in the clinical pathway, allowing more change in treatment decisions compared to other methodologies," iRhythm President and CEO Kevin King summed up.

iRhythm is in no hurry to get to an exit, King said, despite these significant sales of an approved product. It raised a $17 million Series D round in May that was led by Novo A/S. Norwest Venture Partners also participated.

In September, Medtronic ($MDT) launched a similar wireless, wearable cardiac monitor, the Seeq Mobile Cardiac Telemetry System, which includes its own transmitter. It can be worn continuously for up to 30 days, but unlike iRhythm it is considered a second-line option after the Holter monitor. The technology came out of the June acquisition of Corventis, reportedly for more than $150 million.

What to look for: iRhythm is using its latest round to accelerate its marketing and to look at additional indications that it could expand into, as well as to fund further testing to support its flagship product. So, expect to see more data in an effort to demonstrate the benefits that patients and hospitals derive from Zio.

"There are things that have not been possible in the past, but are now because we have a continuous monitoring record," King concluded. "You could call these new biomarkers that allow a differential diagnosis between arrhythmia and other disorders." -- Stacy Lawrence (email | Twitter)

For more:
iRhythm secures $17 million from VCs for its arrhythmia monitor
Aetna agrees to cover iRhythm's cardiac monitoring patch

iRhythm - 2014 Fierce 15