Akili Interactive
The PLOS ONE study included 25 children between the ages of 8 and 12 with ADHD.
The merger with the special-purpose acquisition company Social Capital Suvretta Holdings Corp. I is expected to net Akili up to $412 million.
The Akili team took the latest trends in video game development paired with user-feedback to create the updates.
The company plans to use the new funds to expand its therapeutics beyond ADHD.
The digital therapeutic is designed to treat children ages 8 to 12 with ADHD, but the two studies announced this week will focus on an adult population.
The digital therapeutic for children's ADHD symptoms received a De Novo clearance last summer.
Efficient distribution, dissipating stigma and an emphasis on decentralized trials are all working in favor of digital treatments, according to a panel of digital therapeutics executives and industry stakeholders.
The long-awaited decision is the first regulatory authorization for Akili, and the first game-based therapeutic that the FDA has greenlit for any condition.
In response to recent COVID-19 guidance, the company is releasing its video game-like treatment to qualifying families at no cost, and without explicitly requiring a doctor's prescription.
The large, multi-site investigation described clear improvement in objective symptoms of pediatric attention deficit, but was a bit muddier when describing subjective measures and long-term efficacy.