By Stacy Lawerence


Proteus Digital Health first won an FDA nod for its ingestible sensor in 2012. But now it’s gained an expansion of its label from the agency that indicates that the product can be used to measure medication adherence. That makes it the first and only medical device to have gained this particular indication from the FDA.

An estimated one-half of all patients do not take their medications as prescribed, which results in costs in the U.S. alone of up to $300 billion, the company said. There have been many efforts to improve patient compliance, but Proteus has the first product specifically cleared to do so.

“We are delighted that our collaborative work with the FDA continues to enable positive progress,” said Proteus co-founder and CMO Dr. George Savage in a statement. “We believe that ingestible devices have the potential to speed clinical trials and improve the real-world effectiveness of medicines in community settings.”

The Proteus system includes an ingestible sensor that communicates with an adhesive patch worn on the patient torso. The patch records time of ingestion along with steps, rest and heart rate, and communicates to a mobile app via Bluetooth.

The company has a heavyweight lineup of strategic partners who are also investors, including Novartis ($NVS), Otsuka and Oracle ($ORCL). All three are also investors in the company along with Kaiser Permanente Carlyle Group, Essex Woodlands, Kaiser Permanente, Medtronic ($MDT) and ON Semiconductor.

Last July, Proteus topped up a Series G round to more than $172 million to make it one of the largest digital health financings of the year. A month prior, the company had said the financing would be only $120 million.

The most recent partnership for the Redwood Shores, CA-based company was the one with Oracle; it was announced at the JP Morgan Healthcare Conference in San Francisco, CA, earlier this year. Under the deal, Oracle is slated to integrate the Proteus system into its clinical trial management software system. The idea is to use the Proteus technology to automatically capture data about medication adherence that can give researchers more insight into efficacy and safety, thereby potentially increasing clinical trial success rate.

“The medication adherence option uniquely addresses the most critical information in a clinical trial: ‘Did the patients use their medicine properly?’ Combining this powerful new data with the technology, analysis, and capabilities of Oracle Health Sciences creates a game-changing opportunity for drug development,” said Proteus head of global development Markus Christen in a statement at the time.

Proteus was a Fierce 15 pick in 2012, and it is one of only a couple of private life sciences companies that reportedly has a valuation exceeding $1 billion.