MARCH 2020CIOAPPLICATIONS.COM8DIGITAL THERAPY - 21ST CENTURY MEDICINE?DANIEL SCHOENER, SENIOR DIRECTOR R&D & IVD ADVISOR/FREELANCEIN MY Viewe live in the digital era. One app tracks our sleep and wakes us up at the best time, and another one records our steps. Siri translates our verbal needs into text requests and reads us back the result. Alexa picks the right music and lighting for our homes. Information technology is about to permeate every aspect of our lives. When I learned earlier this year that the FDA had approved the first digital therapies, I was truly intrigued and somewhat mystified. Digital therapy? Is medicine becoming digital, as well?According to the definition of the trade association, DtxAlliance, Digital therapeutics delivers evidence-based therapeutic interventions to patients to prevent, manage, or treat a medical disorder or disease. Powered by high-quality software that combines medical-grade content, patient motivation, and connectivity to the healthcare system, they differentiate themselves from the vast amount of wellness apps through scientific evidence, clinical data, and regulatory approvals. To understand more, let's look at some of the key players and how their products address addiction, ADHS, and Alzheimer's.Pear Therapeutics is the furthest advanced company in the market. In the last two years, it has received two FDA approvals using an accelerated regulatory pathway and has been commercially backed by drug giant Novartis. Both products, reSET and reSET-O, target substance addiction through cognitive behavioral therapy (CBT), a method that changes thinking and behavior patterns through education and positive reinforcement. Using the apps, patients complete lessons and answer a series of quiz questions. They also report medication usage and substance cravings, triggers, and use. The more recent breakthrough product, reSET-O, is a combination therapy with buprenorphine, a drugused to treat opioid addiction, acute and chronic pain. A clinical study with 117 opioid addicts showed increased adherence to a 12-week recovery program: with the digital therapy, 82.4% of the patients completed the entire program, only 68.4% without it. PearTherapeutics has generated $17.5M in revenue in 2019 and has new digital treatments for schizophrenia, insomnia, and epilepsy in its pipeline.The company Lumme uses CBT to help users quit smoking. While Pear's products rely on patient self-reporting, Lumme uses machine learning to detect a cigarette craving automatically. Their app uses data from commercially available smartwatches to track the user's W
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