Digital Therapy - 21st Century Medicine?

Their app uses data from commercially available smartwatches to track the user’s arm movement and detects smoking gestures with an accuracy of 95%. The software predicts cigarette cravings 6 min before the users feel them and sends notifications that encourage them not to smoke. Lumme’s product acts on its own as a stand-alone treatment for nicotine addiction. According to the first randomized clinical trial data Lumme reports the highest quit rates of any product in the market, with 50% of participants of the study being smoke-free After eight weeks.

An example of a digital therapeutics company using gamification is Akili Interactive. Its most advanced product in development, AKL-T01, is a digital therapeutic designed to improve attention in children living with attention-deficit/hyperactivity disorder (ADHD). While playing what feels like a videogame, the kids receive sensory and motor stimuli that target the prefrontal cortex, a brain area affected in ADHD. In a clinical study with 348 subjects the software significantly improved attention measures in children ages 8 to 12 with ADHD after four weeks compared to control. Akili Interactive has filed for FDA clearance of AKL-T01 and i s also studying the technology in other diseases and disorders, including autism spectrum disorder, depression, and multiple sclerosis. The firm has received funding from Amgen and Merck.

Dtherais the only publicly-traded digital therapy company to date and is taking on one of the biggest healthcare problems of the aging population: dementia. This disease area has explicitly been hard to tackle with traditional treatment; 430 clinical trials conducted in the last decade resulted in only one approved drug for Alzheimer’s. Dthera’s digital therapy product DTHR-ALZ has been granted breakthrough device classification by the FDA and intends to treat Alzheimer’s through reminiscence therapy: patients suffering from memory loss are presented with familiar pictures, music, or other materials from the past to activate their memory. A customized tablet computer combines these elements with facial expression detection and artificial intelligence algorithms that can measure the patient’s response to the presented materials and learn to present the content that triggers a positive reaction. In 2017 the company reported a proof-of-concept study with 14 participants thats howedsignificantly reduced agitation and depression in Alzheimer’s patients when using the device. A report of their full clinical study is pending.

Based on the early successes in the field, digital therapeutics have enjoyed increasing attention among investors. In 2018 the top 3 digital therapeutics companiesraised about $170M in funding to continue their programs. According to Price Waterhouse Coopers, a survey conducted in 2019 revealed that 50 percent of consumers said they would be somewhat or very likely to try an FDA-approved app or online tool for the treatment of a medical condition. The FDA, in turn, has created a dedicated pilot program for software pre-certification for solutions such as digital therapies, with currently nine companies being enrolled in it. Currently, the Business Intelligence platform Crunchbase list 79 digital therapeutics firms, and Market Watch estimates the digital therapeutics market to grow to $7B by 2024 at a 21% growth rate.

Today, most digital therapies focus on conditions affecting the central nervous system and psychiatric conditions. There is presently no indication that they will replace drugs in a broader set of diseases in the near future. As the therapeutic area grows, technologies mature, and clinicians start to adopt the products routinely in their practice, digital therapies will unleash their full potential. To this end, they need to continue to prove their safety and effectiveness with strong clinical data.

Many mental health disorders are poorly addressed by the healthcare system today. For affected patients, there is now a digital spark of hope for therapeutic advancement at the horizon.