Tom Clement spent more than a year poking around the University of Washington, looking for the next hot medical device idea to develop after his long run at Kirkland, WA-based Pathway Medical Technologies. And now he’s latched onto a new technology he says could become a low-cost, disposable, and accurate way to diagnose a leading cause of stroke.
The technology is now taking shape at Bellevue, WA-based Cardiac Insight, which is putting the finishing touches this week on a $700,000 financing in Series A preferred stock, Clement says. The company has its license from the UW lab of cardiologist David Linker, and has attracted some well-known directors to its board, including former SonoSite chairman Kirby Cramer and former Physio-Control president Richard Martin. Clement is the CEO, and is now splitting time between Cardiac Insight and another UW spinoff, Aqueduct Neurosciences.
The idea at Cardiac Insight is to develop a new tool for diagnosing atrial fibrillation, or “afib,” which is an irregular heartbeat that affects 2.2 million people in the U.S. each year. This is a hard-to-diagnose condition, since many people with it just feel fatigue. Yet it ends up causing an estimated 90,000 strokes a year in the U.S. among people who weren’t aware of their higher risk from afib, Clement says. There are various devices known as Holter monitors on the market today from big companies like GE, Philips Healthcare, and from startups like San Francisco-based iRhythm. Cardiac Insight is seeking its advantage with a low-cost, convenient device, that’s accurate enough to avoid setting off lots of false alarms.
“Basically this is a super-elegant, 7-day continuous Holter monitor that’s the size of a Band-Aid,” Clement says.
There are a number of problems with the existing technologies for monitoring afib today, Clement says. They depend on electrodes that attach to the chest to pick up the heart rhythm, and sometimes the electrodes are attached to a device that clips onto a belt, making it a bit bulky. Some of the devices record and store heart rhythm data for several days to a week, but then the data needs to be sent to a reading center where expert technicians try to suss out whether the device is picking up a genuine case of afib, or a false alarm, Clement says. Some don’t have much data storage capacity, and are essentially “event monitors” that allow people to push a button when they think something is going on, but which don’t capture the heart rhythm context around that event.
Linker, a cardiologist and bioengineer, has sought to come up with a simple way to diagnose afib with a combination of hardware and software. The device gets stuck onto the patient’s chest with an adhesive, like a bandage that’s four inches long and one inch wide, Clement says. Inside that light bandage there is an electrode to pick up the heart rhythm, a flexible circuit board with memory to store data, and software with an algorithm that processes the data. The patient will wear the device for seven days to collect continuous data on the heart rhythm, or maybe a couple of seven-day periods that aren’t back-to-back, to get enough of a sample size to reach a conclusion. When the patient comes back to the doctor, they rip off the device, plug its USB cord into a computer, and upload the data.
Part of Cardiac Insight’s special sauce is in its software algorithm, which is supposed to minimize the number of false positives, Clement says. That algorithm hasn’t been published in a peer-reviewed journal, and the company has sought to keep that under wraps while it has put together its strategy for intellectual property protection, Clement says.
Since Holter devices have been around for a long time, and the FDA knows them well, Cardiac Insight is seeking to go through the 510k regulatory pathway, which is supposed to allow for quicker and easier market approval of devices that are basic iterations on existing technologies. The company is looking to file a couple of applications to the FDA, for the hardware and software in its device, starting in the first quarter of 2012, Clement says. Being optimistic, he says he’s hoping the company can get FDA clearance to start selling the product in the second quarter of 2012.
Cardiac Insight has been operating as a virtual company with a core group of five contractors, and will continue to do so with the new financing, Clement says. Over time, the company will look to run clinical trials of its own to see how well it performs at picking up afib in various kinds of patients, over different periods of time. The company has gotten a $150,000 award from the state Life Sciences Discovery Fund, which it plans to use to help gather that kind of data for doctors, Clement says.
If all goes according to plan, Cardiac Insight should be able to get low-cost parts for its device that would make it feasible to reach millions of patients with high-blood pressure and a family risk of heart disease, Clement says. It’s possible someday that a primary care physician, not necessarily a cardiologist or neuroradiologist, could prescribe this as a seven-day patch, and then get data that tells whether something’s wrong.
While insurers may want a low-cost device, that’s often not what VCs are looking for. And it’s possible Cardiac Insight will be able to bring its device to large numbers of patients without VCs. So far, the company has raised its money from the Wings angel network and other angels, along with the state Life Sciences Discovery Fund grant. It’s possible that “this could be a $2 million-in-and-$20 million-out kind of deal,” Clement says. That’s quite different from his last company, Pathway Medical, which took 10 years to develop an FDA-approved product, raised more than $130 million in investment capital, and was acquired in August for $125 million.
This time, Clement is taking a different tack.
“I really enjoy important new technologies, and I judge this to be an important new technology,” Clement says. “It’s a different model than anything I’ve used in the past. Most things have required a lot of money, long clinical trials, and long regulatory paths. This has appearance of something that could be a good product to get out with low dollars.”
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