Sky Therapeutics, Florida State University announce first FDA Breakthrough Device designation for ADHD treatment

Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) is granted for new technologies that have real potential to improve outcomes and should get priority attention.  Most new devices fail to attain this status, as the majority of applications are denied.

However, a digital ADHD treatment developed by a Florida State University team achieved the coveted breakthrough designation status.

Developed at FSU and licensed by the startup Sky Therapeutics, Cenextra is the first ADHD treatment to receive Breakthrough Device designation, reflecting its potential to address a growing public health concern. Cenextra uses a patented series of mental exercises presented as popular arcade-style video games, including adventures, quests, puzzles and code-breaking activities designed to strengthen executive functioning in children with ADHD.

Nearly one in nine U.S. children ages 3 to 17 has been diagnosed with ADHD, affecting more than 7 million children, according to the Centers for Disease Control and Prevention. ADHD is associated with challenges in executive functioning, the brain processes that help people plan, organize and regulate behavior.

Researchers developed and evaluated Cenextra in two controlled clinical trials at the FSU Children’s Learning Clinic (CLC) with support from $3 million in National Institutes of Health (NIH) funding.

“Our goal in the Children’s Learning Clinic is to develop effective and accessible non-medication options to help kids with ADHD thrive and be the best versions of themselves” said Michael Kofler, CLC founder and licensed psychologist. “Cenextra has the potential to help a lot of families. We are grateful for the support of FSU IGNITE, which is accelerating development of a version that will be accessible to all families – not just those within driving distance of our Tallahassee clinic.”

The Breakthrough Device Designation was based on the FDA’s evaluation of the evidence from those first two clinical trials. Additional clinical trials are ongoing, supported by another $9 million in NIH funding.

According to the FDA website, an FDA Breakthrough Device “provides for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases/conditions” and “offers significant advantages over existing options.”

The Breakthrough Device Designation is not the same as FDA approval or clearance. Additional regulatory steps would be required before Sky Therapeutics could market Cenextra as an ADHD treatment.

But the Designation does offer additional benefits, including participation in the FDA’s Total Product Lifecycle (TAP) program, which accelerates learning with the FDA including shorter response times, more frequent meetings and prioritized review.

“It is an honor to receive the Breakthrough Device designation, which recognizes years of rigorous research devoted to developing and testing this treatment,” said Leah Singh, CLC director and a licensed psychologist.

The development of Cenextra and collaboration with Sky Therapeutics was supported by Florida State University’s Division of Research. The university is prioritizing support for startups and research translation to maximize the public impact of critical research. These efforts have been backed by the National Science Foundation’s Accelerating Research Translation Grant. The grant provided seed funding to support the transformation of the academic prototype into a product ready for public launch.

Sky Therapeutics, which licensed the Cenextra technology, will continue clinical and regulatory development. Alexey Youssef, co-founder and board member of Sky, said the partnership aims to bring the treatment to families nationwide.

“As a physician, I’ve seen how far the demand for mental health care outpaces the supply of clinical services,” Youssef said. “Cenextra changes that math. It is game-based and has the potential to scale and reach patients wherever they are. I’m proud to work alongside Dr. Kofler and our team as we work to put it in the hands of every family that needs it.”

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Families, clinicians, and patients interested in engaging with Cenextra’s team can visit sky.cenextra.org to learn more.

To learn more about the FSU Children’s Learning Clinic, visit psy.fsu.edu/clc. To learn more about IGNITE FSU visit https://www.research.fsu.edu/ignite.