La Jolla, California-based , the connected vitals signs monitoring device company formerly known as Perminova, has two more multifunction digital health devices in the pipeline to follow up its recently FDA-cleared CoVa Monitoring System. At the BIO event in Philadelphia, cofounder Matt Banet showed off prototypes for a handheld device and a weight scale-like floor pad that each measure the same vital signs and congestive heart failure predictors as the CoVa necklace, while adding their own unique sensing capabilities.
"Our goal is to make simple devices that patients can use at home, that improve compliance, that are easy to use, and, if possible, that measure all five vital signs: pulse oximetry, heart rate, blood pressure, respiration rate and temperature," Banet said, adding that all three devices also measure thoracic fluid, a possible early predictor of CHF.
The Cova monitoring system, a necklace that patients can wear a few times a day to monitor their health at home, got FDA clearance toward the end of May after a two-year process. Banet says it was a positive process, and he predicts the other two devices will make it through in about nine months.
One has roughly the form factor of a connected weight scale (but about twice as large) and measures all of the same things the necklace does: heart rate, heart rate variability, and respiration rate. It uses bioimpedance and ECG to measure thoracic fluid levels and, of course, it also measures weight, which the necklace does not do. The scale will sell for "a few hundred dollars".
"We thought about what are the medical products that have the highest compliance, and there's no question a scale is one of the easiest to use," Banet said. "Unfortunately for heart failure patients, the uptake in weight is the last possible sign [of CHF]."
The company's other new device is a handheld one that consists of a handle and a partial arm cuff. It provides a third way to measure the same biomarkers as the necklace, but adds another: blood pressure. The user holds the device to his or her stomach to measure thoracic impedance, and inflatable bladders in the arm cuff compress the radial artery to measure blood pressure.
Neither device has a display embedded on it; both of them transmit their data wirelessly, so it can be accessed on a mobile device or sent directly to a physician or care manager.
ToSense is considering partnering with health systems and even pharma companies to distribute the devices, but ultimately they're committed to offering them at a low price point to get them in the hands of patients.
"It’s important for us to price things at consumer levels," Banet said. "I think without that the whole model we’re trying to create at toSense falls apart. We do that with good engineering. It’s always a process. To sell something for a few hundred dollars you have to make it for $50. We're not there with everything yet, but we’re getting there."