U.S. FDA Fast-Tracks Floreo’s Virtual Reality System with Admission into both Breakthrough Device Program and TAP Program
Floreo, a leading virtual reality (VR) behavioral therapy company, announces receipt of FDA’s Breakthrough Device designation and acceptance into FDA’s Total Product Life Cycle Advisory Program (TAP Program). The Breakthrough Device Program is intended to streamline the approval process for medical device premarket approval, and the select TAP Program offers valuable insight and resources to assist with the path to commercialization.
Floreo’s virtual reality system is designed to enhance social, communication, emotional regulation, daily living and independent living skills in persons affected by autism spectrum disorder (ASD). Built on neuropsychological and learning concepts that underpin intensive behavioral intervention and cognitive behavioral therapy, Floreo empowers its users by giving them an environment that is safe, controllable, repeatable, and dignified in which to practice important, often difficult-to-teach, skills.
For entrance into the Breakthrough Device Program, the FDA assessed the safety and effectiveness of Floreo based on prior research and interim data from Floreo’s pre-pivotal randomized control study that compared the efficacy of the Floreo intervention to a control group using a sham active VR experience in an autistic pediatric population.
“FDA Breakthrough Device designation and admission into the TAP program are important steps for Floreo as it recognizes the important research investments we’ve made to date,” said Vijay Ravindran, Floreo’s Founder & CEO. “Our goal for participating in these programs is that it will assist us in streamlining approval and access of our system for families,” added Mr. Ravindran.
The FDA Breakthrough Devices Program is intended to expedite the review of promising medical devices that provide for more effective treatment of certain life-long medical conditions. In order to receive Breakthrough designation, companies must demonstrate credible evidence that their technology addresses unmet needs and offers potential improvements over current standard treatments.
The TAP program builds off the Breakthrough Devices Program that targets companies granted breakthrough status that are early in the device development cycle. It provides opportunities for proactive and regular dialogues with industry stakeholders, such as payers and provider organizations, through the product life cycle. The goal is to guide the device toward success by facilitating discussions between companies and payers regarding the necessary evidence for reimbursement in terms of volume and quality. The FDA initiated the TAP program within the Center for Devices and Radiological Health (CDRH) on January 1, 2023.
About Floreo:
Floreo’s vision is a world that is open and accessible for every neurodiverse person. Its mission is to create the first behavioral therapy metaverse, a virtual world that is safe for learners, equipping them with skills and tools they can apply in their everyday lives. Floreo has developed a virtual reality platform that teaches social, behavioral, communication and life skills for individuals with Autism Spectrum Disorder, ADHD, anxiety and other neurodiverse conditions.
For more information, please visit floreovr.com
