OCTOBER 2021LIFE SCIENCES REVIEW9clearance of AKL-T01 and is alsos tudying the technology in other diseases and disorders, including autism spectrum disorder, depression, and multiple sclerosis. The firm has received funding from Amgen and Merck.Dthera is 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 memoryloss 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 presentedmaterials and learn to present the content that triggers a positive reaction. In 2017 the company reported a proof-of-concept study with 14 participants that showed significantly 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 companies raised 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 MarketWatch estimates the digital therapeutics market to grow to $7B by 2024 at a 21 percent 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 abroader 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 these, there is now a digital spark of hope for therapeutic advancement at the horizon. 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
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