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
