As representatives of the emerging mobile health industry convene for their annual summit today in La Jolla, it seemed both timely and appropriate to revisit San Diego-based Sotera Wireless. The company, which was founded six years ago as Triage Wireless, jumped onto our radar screen in April after the medical device company successfully raised nearly $11 million from Qualcomm, Intel, West Family Holdings, and other investors. Last week, I caught up with CEO Tom Watlington to learn more about the company and came away convinced that Sotera, which is within a year of launching its first mobile device, would continue to remain in our sights.
Sotera’s wireless device, dubbed ViSi (for vital signs) and aimed at the hospital market, continuously monitors blood pressure, respiration, temperature, blood oxygen levels and heart rate. The device, a wristband slightly larger than a sports watch, collects vital signs information through two sensors—one on the chest, and one on the thumb—and transmits the data to a hospital workstation. If vital signs deteriorate, an alert goes out.
Watlington tells me that hospitals, often faced with more critically ill patients than their ICUs can handle, want a device that will allow them to continuously monitor the vital signs of very sick patients on general hospital floors. Currently, nurses check these patients’ blood pressure and other vital signs at intervals throughout the day. But Watlington maintains these snapshots can miss the earliest signs that a patient is starting to go downhill.
ViSi doesn’t predict a patient will have a heart attack or some other bad outcome, but functions as an early warning system that a problem may be developing. “Our goal is to develop technology that is very, very sensitive to the earliest signs of deterioration in a patient and alert the doctor or the nurse that something may be emerging so they can intervene,” he said.
Last year, Sotera tested a prototype device for measuring blood pressure at three San Diego hospitals. The 50-patient clinical study pitted the prototype against an invasive device commonly used to measure arterial pressure in most hospital ICUs. The study showed “that for long periods of time the product was accurate and able to read blood pressure without any meaningful drift,” Watlington said.
Sotera is preparing to test the ViSi later this year at five hospitals in San Diego, Orange and Los Angeles counties. Like the previous study, this 46-patient trial will pit ViSi against the invasive method of monitoring blood pressure. If the ViSi works, Sotera will submit its study results to the FDA in late summer or early fall. Watlington expects the company to begin marketing the device during the first quarter of 2011.
When it comes to new equipment purchases, cost is always a consideration. Watlington believes Sotera can make a strong economic case to hospitals, however. Nurses spend about one-third of their time taking measurements and documenting them; because it is automated, the ViSi will reduce the amount of time nurses must devote to taking patients’ vital signs, Watlington says.
Through early detection of changes in temperature, blood pressure and other vital signs, ViSi may help reduce or lessen the severity of adverse events that Medicare and other insurers are reluctant to pay for, like hospital-acquired infections or heart attacks suffered in the hospital, Watlington says.
And sending patients home with a ViSi could reduce the need for costly readmissions, Watlington argues. Medicare generally won’t reimburse hospitals for re-hospitalizations related to the initial condition that occur 30-45 days after patients are sent home.
“If you send patients home with the device and monitor them for a short time, you have the ability to detect when bad things are starting to happen,” he said. “Right now, that period is a black hole with very little monitoring or follow-up care.”
Watlington says the device will be competitively priced, perhaps $2,000-$3,000 a piece.
Founded in 2004, Sotera has raised about $36 million in private equity funding. After its recent financing, Sotera has enough cash to see the company through the commercialization of ViSi and much of 2011, Watlington says. Sotera, which has 35 employees, will probably have one more funding round before it breaks even.
Already, Sotera is working on a second-generation device that will expand the modest electrocardiograph functions of the first-generation device. The follow-on device also will include a modem so it can send data directly to cell phones.
Although the ViSi is wireless, it is not wire-free: a thin wire connects its thumb and chest sensors to the ViSi wrist device. Watlington believes ViSi will ultimately be used by seniors or people with chronic diseases who want to live independently but need close monitoring by their doctors. Alerts could go to a central hub, or a physician’s cell phone. But before patients will use the device long-term, Watlington acknowledges, Sotera needs to “get rid of the wires.”
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