FDA approves etectRx 'digital pill' as rivals struggle


The FDA has approved an ingestible event marker from the privately-held digital health company etectRx, as its rival “digital pill” company Proteus faces financial difficulties.

Florida-based etectRx said the ID-Cap system means this is the first device of its kind to transmit digital messages from within the body to an external receiver without need for direct skin contact.

The system consists of the ID-Capsule, a standard pharmaceutical capsule containing the ingestible sensor known as the ID-Tag.

This emits a very low power digital message from within the patient after it is ingested and activated by the patient’s stomach fluid.

The ID-Cap Reader worn on a lanyard verifies the message is valid and forwards the data to a secure smartphone app and healthcare provider in a secure web-based portal.

Proteus has developed a similar system, except its reader is worn as a patch on the skin.

The news of a potential competitor comes at a bad time for Proteus, which has reportedly furloughed its employees for several weeks because of cash shortages.

An expected $100 million funding round fell through, according to sources quoted by CNBC, and as a result furloughed “the majority” of its employees in November.

Proteus was at one time valued at $1.5 billion, but has managed to bring its employees back to work after it was able to land $5 million in emergency funding.

According to CNBC, the digital pill it has developed with Otsuka, Abilify MyCite, has failed to gain traction.

Otsuka has already invested $88 million in Proteus and has said it is committed to its digital medicine programme, but CNBC said the Japanese firm was unwilling to put in more cash.

Other investors are waiting for more data from the Otsuka deal before putting in more cash, according to the article.

Proteus is not the only digital health company that is struggling: Novartis’ generics division Sandoz has pulled out of its partnership with digital therapeutics firm Pear Therapeutics.

As its rivals face issues with a market that is unready for this new approach to medicine, etectRx said it is working with healthcare providers, health systems, pharmacies, pharma, and clinical research organisations to find applications for its technology.

Researchers at Brigham and Women’s Hospital and Fenway Health are evaluating the ID-Cap system in ongoing and planned clinical studies focusing on HIV medication when used for treatment and prevention.