With uncertainty continuing to surround the ongoing pandemic, Biointellisense Inc. has revealed that it is teaming up with the American College of Cardiology (ACC) to advance remote patient monitoring programs for cardiac care.

In addition, the ACC plans to offer the company's Biobutton COVID-19 Screening Solution at the 70th Annual Scientific Session & Expo, scheduled for May 15-17 in Atlanta. This development comes less than a month after the company reported news around collaborations related to its devices, which are intended to make remote monitoring and early detection simple.

Last year, the Golden, Colo.-based company unveiled Biobutton, a coin-sized, disposable medical device that measures continuous temperature and other vital signs for 90 days. It permits remote data capture and continuous multiparameter monitoring of temperature, respiratory rate and heart rate at rest, body position, sleep and activity state.

Earlier in 2020, the company said that it had gained the U.S. FDA’s nod for its Biosticker on-body sensor for scalable remote care. 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.

With this latest collaboration, ACC will bring its clinical expertise in heart health with Biointellisense's user experience and multi-parameter monitoring to make remote cardiac care more scalable, reliable and cost effective.

DoD recognition

Word of the alliance comes less than a month after Royal Philips NV and Biointellisense reported that the duo will get $2.8 million from the U.S. Department of Defense through a Medical Technology Enterprise Consortium award to validate the Biosticker for the early detection of COVID-19 symptoms. The partners hope to accelerate the use of wearable diagnostics for the benefit of military and public health through the early identification and containment of pre-symptomatic COVID-19 cases.

Biointellisense CEO Jim Mault told BioWorld that in early May, the U.S. Defense Department rendered a solicitation to find a company that could develop a wearable sensor to detect COVID-19 symptoms either in the presymptomatic or early symptomatic phase.

“We responded to that solicitation and at the end of May, we received the notice of award and had the highest scores possible in the review system. The nice thing is that we didn’t have to develop the technology. We already had FDA clearance in December of [2019] for a device that could do exactly what they were looking for.” The offering is unobtrusive and does not interfere with daily activities – features that appealed to the Defense Department.

Because the company is small, it entered the solicitation with Philips serving as the prime government contractor. “It was great to have Philips as a strategic partner to go into this program together.”

He noted that the University of Colorado is the medical center backing it in this validation study, which is assessing an algorithm in development. “[T]his is really intended to collect data from anyone in the country,” he affirmed.

Individuals can enroll online at www.BiostickerCOVIDstudy.com. Eligible participants, such as those exposed to a person who has tested positive for COVID in the past 72 hours and those who have started to develop symptoms in the past 72 hours, can sign up and receive a Biosticker and Biohub overnight. The Biosticker transmits data to a Biohub, which resembles a hockey puck. That device then transmits the data into the cloud for analysis.

Individuals will wear the sticker for 14 days.

The study is expected to enroll 2,500 individuals, and Mault does not expect to recruit beyond that number.

“Right now, it’s a screening tool. We’re not making any claim about diagnosing COVID. We’re just saying, ‘this person’s temperature and heart rate and respiratory rate, each of those things are resembling something that might be COVID.’” Because of that, individuals should stay home from work or school and contact their clinicians.

Helping with the vaccine

Around the same time of the Philips announcement, the University of Colorado Hospital on the University of Colorado Anschutz Medical Campus said some of its health care workers receiving the Pfizer vaccine will wear the Biobutton device as a first step in building a remote monitoring program.

The initiative has a broader goal in terms of getting people vaccinated. Mault told BioWorld that the company wants to be able to have everything working seamlessly as programs nationwide start giving the vaccine to frail, elderly and chronically ill people. “What we’re learning already is these normal, healthy health care workers are asking for it, so we actually already had to expand the program.” He expressed hope that the Biobutton option would help individuals feel safer about the vaccine. This could be particularly important for those who fear a reaction due to allergies to medicines or other irritants.

He also emphasized that the company is not just looking to piggyback off everyone getting the vaccine. “We want everybody to be able to get the vaccine as soon as possible. And if it helps to be able to have a simple way of monitoring, then that’s what this is for.”

The company has a long-term relationship with the school, with Mault serving on its faculty when he performed heart and lung transplants. “When I created Biointellisense, they were with us from the very beginning. So, I’ve brought them into a lot of the different programs and projects that we’re working on.”

Beyond COVID-19, the company has launched several remote patient monitoring programs for routine care, such as for oncology programs to keep an eye on those receiving chemotherapy and other cancer treatments. “We [also] have the Biosticker being used for what we call hospital-at-home programs,” he added, noting that COVID has driven awareness and enhanced practices for sending patients home earlier with the ability to monitor them.

“We’re also launching programs for pre- and postsurgery,” he explained, highlighting orthopedics, cardiology and rehab programs.