What's Happening?
Lumos Labs, known for its brain training app Lumosity, has received FDA 510(k) clearance for its first digital therapeutics app, Prismira, aimed at treating adult ADHD. The app is designed for adults aged 22-55 with primarily inattentive or combined-type ADHD. Lumos Labs launched Lumosity DTx in 2021 to develop treatment tools for neurological conditions, leveraging insights from Lumosity's dataset and published research. The FDA clearance was based on a clinical trial involving 560 adults with ADHD who were not medicated or using similar digital therapies. Prismira is intended to be part of a therapeutic program that may include therapy, medication, and educational programs.
Why It's Important?
The approval of Prismira marks Lumos Labs' entry into the regulated medical device market, expanding its offerings beyond non-clinical brain training. This development could challenge Akili Interactive, the current leader in ADHD digital therapeutics, by providing an alternative for adult patients. The inclusion of digital therapeutics in the 2026 CMS Physician Fee Schedule Proposed Rule could enhance market opportunities for Lumos Labs and Akili Interactive. However, Prismira's approval for adults may limit its impact on Medicare coverage, which could affect its market reach.
What's Next?
Lumos Labs may face market challenges similar to those experienced by Akili Interactive, which has struggled with commercial success despite strong scientific backing. The company will need to navigate these headwinds while leveraging its established direct-to-consumer business model. The potential inclusion of digital therapeutics in Medicare coverage could provide a boost, but the age restriction may limit its benefits. Lumos Labs will likely focus on expanding its market presence and exploring partnerships to enhance its offerings.
