Biointellisense Inc. received good news from the U.S. FDA, which gave its nod to the company’s Biosticker on-body sensor for scalable remote care.
The Biosticker allows for continuous monitoring of vital signs and actionable insights, delivered to clinicians from patients in the home setting. The goal is to help in the early detection of potentially avoidable complications.
The solution is designed to be worn on the upper left chest and can monitor respiratory rate, heart rate at rest and skin temperature. It also can monitor for symptomatic events.
"We are at the inception of a remarkable new era in health care that will employ medical grade sensor technologies to effortlessly capture remote patient data and generate personalized clinical intelligence," said James Mault, CEO of Denver-based Biointellisense.
Getting data at home
When he was a clinician, Mault had at his fingertips a lot of data on patients right up until they went home. “Suddenly, you go from all this data to literally, absolutely nothing – no information at all,” he told BioWorld. That can be a scary moment for patients and their families, as the individual had been monitored constantly. Now, the family is forced to monitor for any complication that develops.
Clinicians, for their part, often are reluctant to send a patient home without having ongoing data to ensure patients are OK. For that reason, they may keep a patient in the hospital or even emergency room longer – a situation that may expose the individual to germs and bacteria.
“There is … a dilemma because we’ve never had a simple, reliable, cost-effective way to send somebody home and still keep an eye on [him or her],” Mault explained. “So, I’ve been spending literally the last two decades of my career building out different technology systems and solutions to solve that challenge.”
He also noted that over the past decade, there has been an explosion of consumer wearables, such as the Apple Watch and Fitbit, a trend he labeled as exciting. “But the reality is those wearables on the wrist are built specifically for fitness, and exercise – a little bit of wellness. They are not medical-grade, clinically validated devices that are FDA regulated.” To feel confident, clinicians must know that the monitors at home are as good as they are in the hospital.
“The medical-grade aspect of this is a key breakthrough for the Biosticker,” he explained. The company wanted something that could “generate vital signs data in a way that’s passive and effortless for the patient and yet something that a doctor and a nurse can rely on for serious medical decision-making.”
The simple sticker
The simplest concept was a sticker, which requires little effort to apply. “The Biosticker – even the name – is to declare ‘this is simple; this is putting on a sticker and literally sticking it on and forget it.’” Despite its simplicity, it is achieving exciting things, collecting data from patients in any setting. It runs continuously for 30 days at a time without the need to recharge it.
Biointellisense also has established a strategic collaboration with UCHealth, a large nonprofit health care system based in Colorado, and its Care Innovation Center to demonstrate the value and clinical applications of the Biosticker device and medical-grade services. This alliance aims to develop and validate new models of data-driven care that are patient-centered and built for scale.
In terms of partnering with UCHealth, Mault noted that the organization is “a unique institution among the traditional landscape of academic medical centers.” It has both a culture and leadership focused on collaboration with innovative companies. To that end, it takes a business-friendly approach that streamlines the IRB process, allowing for approvals in most instances in less than a month. That’s compared to four to six months at other institutions.
For its part, UCHealth has worked to help patients beyond the walls of the hospital. “Probably two years ago now, we started looking at potential partners who are developing devices that could be used outside the hospital,” UCHealth Chief Information Officer Steve Hess told BioWorld. Specifically, it was looking for medical-grade wearables that could be used in the home setting.
Initially, the institution could not find a partner. However, it eventually came upon Biointellisense, which now has realized FDA clearance. “I think we have something special here,” Hess said of the new solution.
With all that the Biosticker provides, Hess said that he did not believe there will be an offering as good as it on the market any time soon.
"The future of health care will see the lines blurred between the hospital, clinic and home," said Richard Zane, UCHealth chief innovation officer and chair of emergency medicine at the University of Colorado School of Medicine. "The use of the Biosticker device for continuous health monitoring enables us to monitor a patient in their home and recognize when a patient may have an exacerbation of illness even before they manifest symptoms.”
Mault also discussed how the solution can help in terms of cost savings. “Hospital length of stay is undeniably increased out of the lack of ability to implement remote patient monitoring in an effortless, cost-effective way,” he explained. By putting the sticker on the patient, a facility can send him or her home a day early. “That one day of hospital cost is, on the low end $1,000, on the high end … could be $2,500.”
It also can help identify possible complications early, allowing a nurse to check on a patient at home rather than have the individual come to the emergency room two days later with full-blown pneumonia, for example.
When asked about wider availability, Mault said the solution will be available to health systems and other interested parties, such as pharmaceutical companies for clinical trials, in coming weeks. The company also is hoping one day to expand the solution globally.
Last summer, Fresenius Medical Care North America made an investment in Biointellisense. The investment was part of Biointellisense's series A financing and was conducted through the Fresenius Medical Care Ventures division.