Akili Interactive Labs has worked for five years to develop mobile video games that can help assess and treat cognitive disorders—and with that work, to accumulate enough clinical evidence to convince the FDA of the games’ benefits.
Akili purposefully set the bar high for commercializing its technology, and the finish line may be almost in sight. The Boston-based company said Friday it raised $30.5 million from investors, money that will help fund a pivotal clinical trial that, if successful, could give Akili the data it needs to win FDA clearance to begin selling its products in 2017.
“We’re excited that, with the support of our new and existing investors, we can continue to advance our adaptive software platform towards clinical validation and commercialization as a fundamentally new type of mainstream medicine,” said Akili co-founder and CEO Eddie Martucci in a press release.
Investors in the funding round include Jazz Venture Partners, Canepa Advanced Healthcare Fund, and PureTech, the Boston-based healthcare investor and startup incubator that co-founded Akili. The company previously raised at least $7 million in venture capital, grants, and industry collaborations with the likes of Pfizer and Shire.
Akili’s technology is based on a decade of research by co-founder Adam Gazzaley’s group at the University of California, San Francisco. Gazzaley works on the science of neuroplasticity and improving cognitive abilities through training. PureTech incubated Akili with the idea of developing a video game platform that could detect brain disorders like attention deficit hyperactivity disorder (ADHD) and Alzheimer’s, as well as improve cognitive function. And the company hired entertainment and video game industry veterans to create games that might also have mass consumer appeal.
There has been a wave of companies in recent years working on apps and games intended to boost brain function, such as improving memory and concentration. Some have come under fire for their marketing practices.
Lumos Labs, which created the Lumosity “brain training” program, recently agreed to a $2 million settlement with the Federal Trade Commission over deceptive advertisements that claimed it could fend off memory loss, dementia, and Alzheimer’s disease. Lumosity lacked the scientific evidence to back up those statements, the FTC said. Lumos Labs has since softened its language.
From its start, Akili aimed to avoid similar pitfalls by securing FDA approval to sell its video games, which run on smartphones and tablets, as a medical device. That requires strong clinical data, which is why Akili is conducting trials in patients with Alzheimer’s, autism spectrum disorder, ADHD, depression, and traumatic brain injury.
Akili intends to go to market first with its Project: Evo product geared toward children with ADHD. In October, Akili announced positive results from an 80-person, open-label pilot study of that product; the company said the results demonstrated improved attention and memory in children with ADHD.
Now, Akili plans to launch a larger, randomized, controlled study to further prove the efficacy and safety of Project: Evo for treating ADHD in children. Akili intends to publish results from that study next year, and if they’re strong enough to earn FDA clearance, Akili said it would begin selling the product by the end of 2017.
