Sky Therapeutics and Florida State University achieve first FDA Breakthrough Device designation for innovative ADHD treatment
Florida – A digital treatment developed by researchers at Florida State University has reached a major milestone after receiving a Breakthrough Device designation from the U.S. Food and Drug Administration (FDA). The technology, known as Cenextra, is the first ADHD treatment to receive this designation, highlighting its potential to provide a new approach for children struggling with attention-deficit/hyperactivity disorder.
The treatment was developed by a team at FSU and later licensed by startup company Sky Therapeutics, which is continuing the process of bringing the technology toward broader use. The FDA designation recognizes medical devices that show strong potential to improve patient outcomes and receive priority attention during regulatory development.
Receiving the Breakthrough Device designation is considered a significant achievement because most applications submitted to the FDA do not reach this level. The status is reserved for technologies that demonstrate meaningful advantages over existing approaches and have the potential to address serious health challenges.
Cenextra was created as a non-medication option designed to help children with ADHD strengthen important mental skills. The program uses a series of patented exercises delivered through arcade-style video games. Through adventures, quests, puzzles and code-breaking activities, the digital platform is designed to improve executive functioning, including skills related to planning, organization and behavior regulation.
ADHD is one of the most common childhood developmental conditions in the United States. According to the Centers for Disease Control and Prevention, nearly one in nine children between the ages of 3 and 17 has been diagnosed with ADHD, affecting more than 7 million children nationwide.
For many children with ADHD, challenges with executive functioning can affect school performance, daily routines and social interactions. Researchers behind Cenextra believe a digital treatment that can be accessed more easily could provide families with another option alongside existing care methods.
The technology was developed and tested through research conducted at the FSU Children’s Learning Clinic (CLC). Researchers evaluated Cenextra in two controlled clinical trials, supported by $3 million in funding from the National Institutes of Health (NIH).
“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 FDA’s decision to grant Breakthrough Device designation was based on evidence collected during those initial clinical trials. Additional studies are currently underway, supported by another $9 million in NIH funding, as researchers continue evaluating the treatment’s effectiveness and potential impact.
According to the FDA, a Breakthrough Device is intended to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating conditions while offering significant advantages compared with available options.
However, the designation does not mean Cenextra has received FDA approval or clearance. Sky Therapeutics must complete additional regulatory steps before the treatment can be marketed as an ADHD therapy.
Still, the designation provides important benefits during development. Sky Therapeutics will have access to the FDA’s Total Product Lifecycle (TAP) program, which is designed to improve communication between developers and regulators. The program can provide faster feedback, more frequent discussions with FDA officials and prioritized review processes.
“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 reflects a broader effort by Florida State University to move research discoveries beyond the laboratory and into products that can benefit the public. FSU’s Division of Research supported the collaboration with Sky Therapeutics as part of the university’s focus on entrepreneurship, startup development and research translation.
Those efforts were also supported by a National Science Foundation Accelerating Research Translation Grant. The funding provided early support to help transform the academic prototype into a product designed for wider public availability.
Sky Therapeutics, which licensed the technology from FSU, will continue leading clinical development and regulatory work. Company leaders say the goal is to make the treatment available to families across the country.
Alexey Youssef, co-founder and board member of Sky Therapeutics, said the partnership is focused on addressing a growing need for accessible mental health care.
“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.”
The achievement represents years of research, testing and collaboration between university scientists, healthcare professionals and industry partners. While additional evaluation and regulatory review remain ahead, supporters say the FDA designation marks an important step toward expanding treatment options for children with ADHD.
If future trials continue to demonstrate positive results and regulatory requirements are met, Cenextra could offer families a new digital tool designed to improve executive functioning skills in a format that is engaging, accessible and easier to deliver beyond traditional clinical settings. For researchers at FSU and Sky Therapeutics, the milestone represents not only recognition of past work but also the beginning of a larger effort to make innovative ADHD care available to more children and families.
