etectRx, Inc. is a privately held digital health company seeking to advance patient medication adherence and improve ingestion tracking technology. etectRx’s flagship product, the ID-Cap System, is an ingestible event marker comprised of a gelatin capsule containing an ingestible sensor that transmits signals to a wearable reader which sends the data to a smartphone-based app and secure cloud-based server to enable reliable tracking of ingestion events.
etectRx recently announced FDA clearance of the ID-Cap® System. The ID-Cap System is the first and only ingestible event marker to transmit digital messages from within the body to an external receiver without the need for direct skin contact for the purpose of recording ingestion events.
As part of the company’s strategy to gain market acceptance etectRx is collaborating with key stakeholders, including researchers at Brigham and Women’s Hospital and Fenway Health to evaluate the ID-Cap System in ongoing and planned clinical studies focusing on HIV medication when used for treatment and prevention.
The only other company currently in the bioingestible sensor market is Proteus Digital Health (Proteus). Proteus’ solution is to have patients swallow a sensor with their medication. The sensor, an ingestible event marker, or IEM, along with a wearable sensor patch, tracks how the patient and the pill are responding. That sensor and patch record when the pill was taken and how the patient’s body responds, as measured by their heart rate, respiration, body angle, temperature, and more.
The data is transmitted to a phone or a website, and can be sent directly to caregivers, who can adjust the dosage or change the medication, provide coaching, or respond to changes in the patient that may demand immediate attention. Proteus’s IEMs are being tested among patients suffering from cancer, infectious diseases, or mental health disorders.
Otsuka and Proteus combined Otsuka’s ABILIFY® (aripiprazole) with the FDA-cleared Proteus® ingestible sensor, embedding the sensor in single tablets at point of manufacture. The FDA granted its first approval of a Digital Medicine, ABILIFY MYCITE® (aripiprazole tablets with sensor), on November 13, 2017.
Proteus, once valued at $1.5 billion, is now struggling to survive as the company is undergoing a restructuring after failing to close a $100 million funding round that forced it to furlough the majority of employees. Investors have become concerned as Proteus’ growth with patients has weakened. Otsuka is reconsidering its $88 million, five-year partnership.
Bioingestible sensors can play a significant role in several conditions, such as mental health, infectious disease (e.g., HIV, TB, Hepatitis), and oral oncology due to several factors, including patient disposition, drug costs, and public health concerns.
Takeaway: Bioingestible Sensors are a disruptive tool to assess medication adherence.