Proteus Digital Health Shows Reliability of its Helius Smart Pills

According to Proteus Digital Health, the company’s sensor-laden pills demonstrated a 99.1 percent detection rate of medication adherence during clinical trials.

As human lifespan lengthens, more people face the challenge of managing chronic diseases. A crucial aspect of dealing with these conditions is medication adherence. Unfortunately, only 50 percent of individuals with chronic conditions comply with their complicated drug regimen, according to the World Health Organization. As a result, patient outcomes continue to be dismal and the total cost incurred due to poor compliance is believed to run up to $289 billion annually, according to Bloomberg.

A pioneering company who is offering a viable solution to poor medication adherence is Proteus Digital Health. It is betting its future on digital medicine—wearable, implantable and ingestible sensors, mobile communications, and online patient communities—to solve healthcare problems. It is starting with solving medication adherence through its FDA-approved ingestible sensors and dermal patches.

In a recent study that demonstrated the reliability and safety of their edible Helius sensors, Proteus claimed that the tiny (as small as a grain of sand) sensors embedded in pills taken by 412 test patients were able to detect ingestion 99.1% of the time. The sensors correctly identified the type and dose of the drug taken 100% of the time for all 20,993 ingestions during the trial. There were no recorded false positives and zero incidence of serious adverse event (SAE) and unanticipated adverse device effect (UADE).

As described in the study, the microfabricated sensors are embedded into tablets and capsules during manufacturing. Upon ingestion and contact with gastric fluid, thin layers of magnesium, copper and gold inside the minute sensor react with the gastric fluid to start an electrochemical reaction, essentially creating a “battery” that powers the device. The process lasts until the materials are exhausted, during which time the sensors communicate and sends to a skin-worn patch a unique digital code to identify the type of medication, amount of dosage and the time of ingestion.

Aside from sending drug ingestion data, the sensor correlates this with other metrics like physical activity, heart rate, blood pressure and sleep quality measured by the bandage-like sensor. The disposable skin patch then sends all data wirelessly via Bluetooth to a smartphone app which displays the metrics for the user and healthcare providers to see in real-time.

The safety of the device was tested according to standards set by ISO-10993 International Standard for Biological Evaluation of Medical Devices. According to the study findings published in IEEE, the ingestible sensor passed all tests of chemical, toxicological, mechanical and electrical safety.

The authors of the study described Proteus’ ingestible sensor as “the first instance of a microfabricated integrated circuit developed and approved for daily ingestion by patients” to directly measure ingestion events and correlate medication adherence to other physiologic factors. Beyond medication adherence, the sensor may also be combined with nutritional and food supplements to measure athletic performance, the authors wrote. Finally, “the availability of a proven and safe ingestible integrated circuit can enable a new generation of “smart” drug delivery dose forms, with the ability to generate very specialized drug release profiles, target specific locations, and respond to local sensing events.”

Providing researchers and clinicians with accurate, real-time and complete information on medication adherence, and how drugs influence vital signs and other physiologic data, can be invaluable in treating patients.

According to a Frost and Sullivan report, smart pills will reach a zenith by 2018-2020 due to a need for minimally invasive, fast and seamless therapeutic and diagnostic solutions. Companies have different approaches to solving medication non-adherence. AdhereTech’s smart pill bottles reminds patients to take their pills on time. Meanwhile, Proteus’ system can confirm if the pill was actually swallowed.

Right now, Proteus is in the forefront of developing ingestible sensors and making them part of a complete mHealth solution, but more companies may be joining the fray soon, as more research prove the safety and reliability of these novel devices.

“I think it's possible there will be other companies that will try to duplicate our technology. Our mission is to enable a whole new way of delivering health services,” Andrew Thompson, CEO of Proteus, told FastCoExist.

Proteus Digital Health is one of the most-funded digital health companies in the world, with nearly $400 million from various investors, according to MobiHealthNews. Among its backers is Oracle, which purchased a minority stake in 2013.