Investors Commit $172 Million for Development of Ingestible Data Devices to Monitor Effectiveness of Therapeutic Drugs In Vivo

With other companies also advancing ingestible and wearable technology, these new sources of useful diagnostic information may soon become available to pathologists and medical lab professionals

Ingestible sensors are now in the marketplace! These devices are designed to be swallowed by the patient. The device will then send the patient’s vital health data to a smartphone. No imagination is needed by pathologists to understand how such devices could generate diagnostic data in real time that could supplement traditional medical laboratory tests.

These ingestible sensors are designed with the goal of helping track both the adherence of patients to their prescription drug regimens and the effectiveness of these prescription drugs.

Proteus Digital Heath of Redwood City, California, is one company that has introduced an ingestible sensor that sends a person’s vital health data to a smartphone, reported Smart Planet in a story it recently published.

Investors Pony Up $172 Million to Develop Ingestible Data Devices

Investors must like the device. Proteus raised more than $172 million in funding. It will use the money to manufacture “digital medicines—pharmaceuticals that integrate medicine with ingestible and wearable mobile and cloud computing,” noted a company press release on the funding agreement.

Moreover, Proteus is not the only company advancing this new technology. MC10, HQ, Inc., and MicroCHIPS are three other companies working to bring ingestible data devices to market.

The development of devices like these may have significant implications for clinical laboratories. Digital medicine-related devices may soon enable patients to download and wirelessly forward to providers (including their medical laboratory) not just real-time information about their adherence to medications, but data about biomarkers that can be used for diagnostic purposes by pathologists and clinical laboratory scientists. Should this come about, it will give pathologists and their lab teams new opportunities to diagnose patients and monitor their response to different therapies in real time.

Proteus’s Pill and Patch System Deliver Real-Time Monitoring of Oral Meds

One example of an ingestible data device is the Proteus System (pictured above) that was developed by Proteus Digital Health of Redwood City, California. The system involves two elements working in sync: 1) an ingestible sensor—a tiny computer about the size of a grain of sand that attaches to a patient’s pill; and, 2) a patch worn on the body. No battery is required because the system utilizes a smartphone to collect the data and transmit it to the patient and his or her physician. (Photo copyright Proteus Digital Health.)

One example of an ingestible data device is the Proteus System (pictured above) that was developed by Proteus Digital Health of Redwood City, California. The system involves two elements working in sync: 1) an ingestible sensor—a tiny computer about the size of a grain of sand that attaches to a patient’s pill; and, 2) a patch worn on the body. No battery is required because the system utilizes a smartphone to collect the data and transmit it to the patient and his or her physician. (Photo copyright Proteus Digital Health.)

In the next stage in the development of its products, Proteus hopes to obtain Food and Drug Administration clearance to put its ingestible sensor inside prescription pills. As it is currently designed and used, the patient digests the sensor separately from the medication. The system works like this, according to the Smart Planet report:

  • The patient swallows the pill and it dissolves away from the sensor (which later passes out of the body as waste);
  • Two metals—magnesium and copper—help activate the sensor as it comes in contact with stomach acids;
  • Signals are sent to the patch worn on the outside of the patient’s body;
  • The patch registers the time medication was taken, heart rate, activity, and rest patterns and sends this data wirelessly via Bluetooth to a smartphone app;
  • The patient decides to send this information to a physician, family member, or other contact.

The technology used by the Proteus System is called volume conduction. Essentially, the computer in the ingestible device emits a series of tiny electric pulses, which a patch on the patient’s skin picks up.

How the Body Responds to the Therapeutic Drug

“Correlate these two data streams—the one from the pill and the one from the patch—and you get a picture of your body responding to a pharmaceutical,” explained Alexis Madrigal, visiting scholar at Berkeley’s Center for Science, Technology, Medicine and Society. He was quoted in a National Public Radio interview.

Alexis Madrigal is a visiting scholar at the University of California Berkeley’s Center for Science, Technology, Medicine, and Society. He is watching the development of ingestible data devices and noted that such devices can help researchers and physicians understand how a patient’s body is responding to a therapeutic drug. (Photo copyright Proteus Digital Health.)

Alexis Madrigal is a visiting scholar at the University of California Berkeley’s Center for Science, Technology, Medicine, and Society. He is watching the development of ingestible data devices and noted that such devices can help researchers and physicians understand how a patient’s body is responding to a therapeutic drug. (Photo copyright Proteus Digital Health.)

The Proteus System is reportedly being used in a limited way now by family members who want to track loved ones with chronic illnesses.

Proteus’s goal is to digitize half of medications currently cleared for clinical use, according to Arna Ionescu, the company’s Vice President of User Experience and Design. “Currently, people have very minimal engagement with their health, and it’s not working well, if you look at the trends in chronic illness. We’re trying to make the process of taking medicine much richer,” she told Smart Planet.

Report Suggests Poor Medication Adherence Costs Billions

When people don’t take their medications as prescribed, the result can be unnecessary illnesses, disability and premature death, according to a report from the Network for Excellence in Health Innovation (NEHI).

In the United States, about 50% of patients on prescription medication don’t take their medicines as directed, the report found. In fact, the NEHI  report also noted that medication adherence problems result in $290 billion of unnecessary healthcare spending.

While these data are compelling, systems like the one created by Proteus may not be so easy for payers and patients to swallow. That’s because health insurers may demand proof that that cost of the Proteus System warrants abandoning popular generic medicines.

As well, some patients are likely to be concerned about the privacy and ease of use of the ingestible pill, reported BioCentury on BioBusiness in its story about the Proteus ingestible system.

More Companies Offering Ingestible, Wearable Technology

Competitors are developing their own products for the ingestible and wearable sensor market. MC10 is already testing its Biostamp product on healthy people.

Its device is about the size of two postage stamps. Once the Biostamp is attached to the body, it senses the monitor temperature, movement, heart rate, and more. It transmits the data wirelessly to patients and their clinicians, noted an article published by Fast Company.

Patients with movement disorders, such as multiple sclerosis, epilepsy, and Parkinson’s, may eventually be part of the device testing, a spokesperson told Fast Company.

The ingestible device at HQ, Inc. is called CorTemp. It is an ingestible core body temperature sensor that wirelessly transmits core body temperature as it travels through the digestive tract, according to the company’s website.

The sensor sends a signal to a CorTemp data recorder worn outside the body. The National Football League uses the FDA-cleared sensor to help prevent heat exhaustion among its players, noted a report by the American Association of Pharmaceutical Scientists.

Another example of an ingestible device was profiled in 2012 in a story published by the journal Science. Translational Medicine published results of the first human test of a wirelessly controlled drug delivery microchip that was developed by MicroCHIPS of Waltham, Massachusetts. In its press release, MicroCHIPs described how women with osteoporosis received daily doses of the drug teriparatide through microchip delivery instead of daily injection.

The study showed compatibility of device and drug without adverse immune reaction. Now MicroCHIPs is looking to develop ingestible systems for other diseases, such as cardiovascular disease, multiple sclerosis, cancer, and chronic pain, according to its news release.

While ingestible and wearable technologies face challenges, they are also making headway. Mega financing, such as the $172 million investment announced by Proteus Digital Health, is being secured. Multiple clinical trials are underway and patient safety milestones are being met by credible companies.

Another Source of Diagnostic Information That Can Be Used by Pathologists

Will the eventual widespread use of ingestible devices open new doors for pathologists and clinical laboratory scientists to tap this data and use it for diagnostic purposes? The answer to that question is several years into the future. Moreover, the focus of most technology development efforts centers upon use of these devices for monitoring patient compliance with their prescription drugs. Thus, no disruptive or breakout of  applications for diagnostic purposes seems likely in the short term.

—By Donna Marie Pocius

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