Tracking not just data, but individual symptoms, like vomiting: BioIntelliSense exits stealth with FDA-cleared wearable

After getting off the ground about 18 months ago, Denver-based BioIntelliSense has already obtained an FDA 510(k) clearance for its vital sign data as well as Medicare coverage courtesy of recent codes for remote patient monitoring while staying largely under the radar. (BioIntelliSense)

A new digital health startup is exiting stealth mode with its advanced, long-lasting patient monitoring device—and touting a quick FDA clearance to boot.

Denver-based BioIntelliSense raised the curtain (PDF) on its wearable BioSticker, which aims to do more than simply collect clinical-grade vital signs and raw activity data. Using a combination of different sensors, it can track and identify distinct symptomatic episodes such as coughing, sneezing or vomiting.

With a 30-day battery life, the BioSticker is designed to provide clinicians and surgeons with the kind of monitoring they would find within the inpatient, hospital setting, but from a patient’s home and spanning the weeks before or after a procedure.

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“This isn’t a one-time snapshot … It’s not like when you go to the doctor and they might have 20 minutes to check you,” BioIntelliSense CEO and founder Jim Mault told FierceMedTech in an interview. “Here, you’re wearing a sticker for two weeks. Instead it’s almost like a movie—you can see what they look like day after day after day.”

“And that’s powerful. We’re going to be able to anticipate or prevent a lot of problems that, in the past, took us by surprise,” Mault said. For example, if a cancer patient were shown to be vomiting in the days following chemotherapy, a care team could reach out with directions to take nausea medication and stay hydrated.

Worn on the chest, the passive, set-it-and-forget-it device is built to withstand daily activities such as showering while uploading readings to BioIntelliSense’s platform covering heart rate, respiratory rate, body position, walking gait, skin temperature and more.

That information could provide much-needed light in the preoperative setting as well.

“We ask patients, ‘Have you had any fevers in the past two weeks?’ And the patients go, ‘Not that I know of,’” said Mault, who has been trained and board-certified in cardiothoracic surgery. “But then I'm looking at this sticker data, and it can tell me that this person had a low-grade fever for two days in the past week. So it’s probably not a good idea to put in a new heart valve.”

“But before, nobody was measuring this. And as the surgeon I wouldn’t know the difference—I could wheel them into the operating room and put a valve in, but nobody would know there’s bacteria running around in this person, and now they have an infected valve,” he said. “They could be on six weeks of antibiotics or they might die.”

After getting off the ground about 18 months ago, the company has already obtained an FDA 510(k) clearance for its vital sign data as well as Medicare coverage courtesy of recent codes for remote patient monitoring. Now, BioIntelliSense has also launched a collaboration with the University of Colorado’s health system, UCHealth, to help further demonstrate and explore the system’s clinical applications.

As a business model, BioIntelliSense plans to package its BioSticker sensor with its data collection and analytics platform, offering both on a per-patient, per-month basis. The full service should be commercially available in the U.S. within a matter of weeks, according to Mault.

The company has stayed largely under the radar, save for a July 2019 announcement regarding Fresenius Medical Care North America’s investment in the company and their plans to work on applications related to home dialysis care.

In the meantime, UCHealth plans to use the BioSticker to help enable earlier discharges by monitoring patients for complications while they’re at home instead of in a hospital bed.

“We can now target certain segments of the population, starting with patients who are at most risk for deterioration, so that we can surveil them and intervene before they become symptomatic,” said Richard Zane, chief innovation officer and chair of emergency medicine at UCHealth. This would include patients with diabetes, heart failure, kidney disease, emphysema or asthma; all may be at risk for worsening disease.

“There are people who will say that inpatient care is a failure of outpatient care, and that outpatient care is a failure of preventative care,” said Zane. “This will allow us to bend the needle away from being reactive, toward being proactive.”

“Think about the entire spectrum of healthcare becoming proactive instead of reactive—that’s really where the rubber meets the road. That’s where tremendous health savings happen … where patients who would have gotten sick are not getting sick, or patients who would have required admission are not going to require admission. It allows acute, reactive care to become proactive.”

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