Biointellisense Inc. received an FDA clearance in January for its Biosticker to monitor patient vital signs at home for as long as 30 days. It was just starting to launch, when along came the novel coronavirus. Now, the Band-Aid-sized monitor is being used to monitor COVID-19 patients at home, as well as chronic disease patients.

To further expand its reach, the Denver-based startup has partnered with Royal Philips NV in a deal that integrates the wearable and its data into Philips’ remote patient monitoring systems. Biointellisense is rapidly scaling up manufacturing in multiple countries with the capacity to produce the Biosticker in quantities into the millions.

ICU to home

Philips has been busily rolling out its own remote monitoring patches into the U.S. during the pandemic, including one designed for use in the hospital to prevent further COVID-19 patient deterioration and another to monitor pregnant women in labor in obstetrics units. The Biointellisense collaboration adds to its capabilities, which span from the ICU into the hospital and then home.

“The natural extension is starting to also monitor in the home, and doing that with a sensor that can actually really measure the vitals will help us to do relevant diagnosis and to keep a broad set of vitals being measured and help us to get to early alerts and detection,” Roy Jakobs, chief business leader of Connected Care at Philips told BioWorld.

“We're really looking at what we can do ourselves, what we can do with partners,” he continued. “Sensors are becoming a bigger theme within health care, especially also if you look at usability. People are willing to use it and don't feel hampered. The system supports it and we can enable it with technology and innovation.”

The Biosticker is a disposable, small patch that’s worn on the upper left portion of the chest. It monitors physiological biometrics and symptomatic events including skin temperature, resting heart rate, resting respiratory rate, body position, activity levels and cough frequency. It incorporates adhesives such as those for continuous glucose monitors for placement, which can be replaced every week or so as needed.

It’s being used on COVID-19 patients who are returning home after major hospitalization to continue to monitor them, as well as on those who are not quite ill enough to merit hospitalization but whom the hospital would like to continue to monitor. In addition, it’s useful for monitoring at-risk chronic disease patients at home, including those with diabetes, cancer or congestive heart failure.

“You never want to rely on just one piece of data,” said James Mault, CEO of Biointellisense on diagnosing worsening COVID-19. “When somebody gets an infection, your heart rate goes up. That's a natural concurrency – with a rising temperature, your metabolic rates go up, so your heart rate goes up. But also, the breathing rate goes up, because you need more oxygen to feed that fever.”

“So, you're breathing faster, your heart rate is going up, your temperature is going up, and we're watching you cough more because this is a respiratory illness,” he continued. “The combination of those four variables, all independently tracking in the same direction, gives you an unprecedented capability that you otherwise would have never had, especially in the home setting.”

Remote monitoring gets real

Mault, a former cardiac surgeon, founded the care coordination platform Healthy Circles that was acquired by Qualcomm Life in 2013. He spent the next five years as senior vice president and CMO at Qualcomm Life, then left to start Biointellisense.

His aim was to design a remote patient monitoring system that would be simple, medical grade, encrypted and secure, as well as algorithms to monitor the continuous data. Mault brought an existing team of engineers in-house from a consumer wearable company; they were able to go from the initial concept through design and validation and to FDA clearance in only 18 months.

The Biosticker is the first single-use medical device cleared for thirty days of continuous vital sign monitoring. Measuring cough frequency is also a new capability for any type of medical monitoring.

The Biosticker transmits data to a Biohub, which resembles a hockey puck. That device then transmits the data for analysis into the cloud for analysis. Physicians can apply specific rules and filters personalized for an individual patient to receive alerts and reports. This data is also integrated into dozens of electronic medical records and remote patient monitoring software systems for viewing of the data.

The lack of reimbursement, particularly for physician time spent reviewing data from at-home monitoring systems, has long hampered adoption. But that pathway for reimbursement has recently been established by the Centers for Medicare & Medicaid Services (CMS); its policies often pave the way for U.S. private insurers as well.

“Somebody needs to pay for it,” observed Mault. “The great news is just over the past year, Medicare, working with the American Medical Association, established and launched new reimbursement codes that pay for doctors to be reimbursed to spend time taking care of patients using remote patient monitoring technologies. It also pays for the technology itself, so that was a very big breakthrough and opens the door to making remote patient monitoring something that is incentivized in the medical community.”

In addition to Biosticker, Biointellisense also markets the FDA-cleared Biobutton. It’s a slightly scaled-down iteration that’s coin-sized and continuously measures temperature, respiratory rate and heart rate at rest, body position, sleep and activity state for ninety days.

Rather than for patients, many hospitals are turning to the Biobutton to monitor hospital staff to help ensure this high-risk population is COVID-19 free and to support contact tracing efforts. Biointellisense has even been approached by nations looking to use the Biobutton to more accurately enforce border control and monitor quarantined people.

“The Biobutton is specifically designed for that surveillance scenario. It's about the size of a quarter, so it's really quite small and unnoticeable,” said Mault. “You're going to see tens of thousands, now hundreds of thousands, of health care workers, and even sovereign governments who are working with us to use this.”

“The Biobutton is the basis of being able to open the borders,” he continued. “If you have a sticker for up to 14 days, that'll allow you to be able to be out and about without necessarily having to stay in quarantine. But if you are in quarantine, this is the best way to monitor you. We're also able to do contact tracing with the device.”