Proteus and Otsuka head to FDA with drug adherence combo device

Ingestible sensor pill, patch and iPad app--Courtesy of Proteus

Proteus Digital Health and partner Otsuka have submitted an application to the FDA for approval of their innovative drug adherence device, a milestone for Proteus months after scoring the agency's clearance for its sensor product.

The companies' device embeds Proteus' ingestible sensor into Otsuka's Abilify med for severe mental illnesses including schizophrenia, allowing patients, physicians and caregivers to monitor how an individual takes the drug. Proteus' sensor sends a signal to a wearable patch after it reaches the stomach, and the patch then records and time-stamps the information, sending it back to a mobile phone or Bluetooth device. The sensor also records other patient metrics such as rest, body angle and activity patterns, giving a better picture of what a patient is doing while they're taking the med and potentially improving adherence.

About 50% of patients with chronic diseases in developed countries do not take their meds as prescribed. And in the U.S., this could translate into $100 to $300 billion in avoidable healthcare costs, the companies said in a statement. Proteus is aiming to change those numbers with its device.

"Today, patients suffering from severe mental illnesses struggle with adhering to or communicating with their healthcare teams about their medication regimen, which can greatly impact outcomes and disease progression," William Carson, president and CEO of Otsuka's pharmaceutical development and commercialization unit, said in a statement. "We believe this new Digital Medicine could revolutionize the way adherence is measured and fulfill a serious unmet medical need in this population. We look forward to continuing working with the FDA throughout the NDA review."

Adhesive patch--Courtesy of Proteus

Meanwhile, Proteus is working hard to keep up the positive momentum with its device, striking deals and roping in new funds to support development. Last July, the Redwood Shores, CA-based company raised $172 million in a Series G round, one of the largest digital health financings of the year and topping its previous estimates of $120 million.

Earlier this year, Proteus said it would team up with Oracle to integrate its sensor into the company's clinical trial management software system. If all goes to plan, Proteus' technology will automatically capture data about drug adherence, giving researchers more information about safety and efficacy while increasing the success of clinical trials.

And the company isn't showing any signs of slowing down. Proteus boasts a valuation of $1 billion, The Wall Street Journal noted earlier this year, setting it among the ranks of other promising tech startups in the field.

- read the statement

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