<div id="readability-page-1"><div> , /PRNewswire/ -- Floreo, a developer of virtual reality (VR)-based therapeutic technologies, today announced the submission of a De Novo request to the U.S. Food and Drug Administration (FDA) for FloreoRx, its software-based product being evaluated for use in supporting skill development in individuals with Autism Spectrum Disorder. FloreoRx is an investigational device and has not yet been cleared or approved by the FDA. <img src="https://imageproxy.pbkrs.com/https://mma.prnewswire.com/media/2657071/Floreo_Logo_Color__1_Logo.jpg?x-oss-process=image/auto-orient,1/interlace,1/resize,w_1440,h_1440/quality,q_95/format,jpg" width="400" height="219" original-src="https://imageproxy.pbkrs.com/https://mma.prnewswire.com/media/2657071/Floreo_Logo_Color__1_Logo.jpg"/> In 2023, Floreo became the first VR autism technology to receive the FDA's Breakthrough Device Designation, a program designed to expedite the development and review of technologies that may provide more effective treatment for serious conditions.For many families and clinicians, access to consistent, high-quality autism therapy remains a persistent challenge. If authorized, FloreoRx could become one of the first FDA-authorized therapeutic devices intended to address core social communication challenges associated with Autism Spectrum Disorder. Using a VR headset and FloreoRx, behavioral therapists deliver structured experiences that enable users to safely develop and practice social communication skills through real-world scenarios and interactions.The submission is supported by data from Floreo's pivotal trial which utilized FloreoRx within Applied Behavioral Analysis (ABA) autism therapy evaluated against an active VR sham control. The study was 100% monitored and among the largest prospective, multi-site randomized controlled trials of a VR-based intervention conducted in children with autism.The pivotal trial was conducted in partnership with Cortica Healthcare (Cortica) across 18 clinical sites nationwide, leveraging Cortica's gold-standard integrated autism care model. Additionally, MCRA served as CRO and Highland BioMed provided strategic regulatory assistance with the preparation of the De Novo submission.The trial focused on core social communication challenges associated with Autism Spectrum Disorder, assessed using the Autism Impact Measure (AIM). At clinically interpretable thresholds of improvement, participants receiving Floreo treatment demonstrated higher responder rates than those in the VR control group (e.g., 45.6% vs. 23.3%), with statistically significant differences between groups. These results were supported by consistent improvements across clinician-rated and functional measures.Importantly, this trial also reflects the scale and operational capacity required to generate meaningful results in real-world care settings. Cortica enrolled 125 patients and coordinated more than 150 behavioral technician VR coaches and 15 blinded assessors across all sites involved in the study over a 15-month period, spanning both blinded therapy delivery and crossover.&#34;The clinical research continues to validate what clinicians and families are seeing every day: immersive VR can meaningfully support skill development for autistic learners,&#34; said Vijay Ravindran, founder and CEO of Floreo. &#34;Three things stand out in the trial: 1) That Floreo could achieve statistically significant results with a dosage of 18 minutes per week over 12 weeks, 2) That Floreo performed better as the severity of symptoms increased, and 3) that improvements continued to strengthen after 60 days.&#34;Clinical Highlights Include:<ul type="disc"><li>Social Skills: Clinician-administered CARS-2 evaluations showed a statistically significant LSMean change of -4.5 for the Floreo group versus -2.2 for the control (p = .0182).</li><li>Subgroup Analysis (Highest-Burden Baseline): Participants in the highest-burden tertile at baseline demonstrated a 72% responder rate compared to 30% in the control group (p=0.009).</li><li>Post-Treatment Observation: Improvements observed in AIM scores for the FloreoRx group at the 12-week end-of-treatment mark were sustained at the 60-day follow-up evaluation.</li><li>High Skill Mastery: A majority of participants (95.1%) mastered one or more new skills by the end of treatment, as measured by the Assessment of Functional Living Skills.</li><li>Family Quality of Life: Caregiver-reported CFQL-2 reports on family quality of life showed a between groups difference that was statistically significant for the Floreo group versus the control of 0.152 (p = 0.032).</li><li>Crossover Findings: Participants who initially received the VR control demonstrated improvements after transitioning to Floreo treatment, supporting the consistency of the observed treatment effect.</li><li>Safety Profile: No serious adverse events were reported in the study, and observed adverse events were generally mild and transient.</li><li>High Engagement and Satisfaction Across Stakeholders: High levels of satisfaction were reported across clinicians and caregivers, including clinician-reported enjoyment of VR (98%) and willingness to use it as a treatment tool (88%), as well as parent-reported child enjoyment (93%) and interest in using VR as part of therapy (86%).</li></ul>If authorized, Floreo intends to make FloreoRx available as an adjunct to existing therapeutic approaches, with the goal of expanding access to structured, skills-based interventions for the approximately 3% of children in the United States diagnosed with Autism Spectrum Disorder, where access to consistent, high-quality therapy remains a significant challenge.Floreo currently offers a commercially available VR platform designed for general wellness and skills development that does not make medical or therapeutic claims. FloreoRx is a separate investigational product under FDA review.About Floreo Floreo's vision is a world that is open and accessible for every neurodiverse person. Through immersive virtual reality experiences, Floreo creates safe, engaging environments where learners can build skills and tools they can apply in their everyday lives. Floreo's virtual reality platform teaches social, behavioral, communication, and life skills for individuals with Autism Spectrum Disorder and other neurodiverse conditions. For more information, please visit floreovr.com. <img width="12" height="12" src="https://imageproxy.pbkrs.com/https://edge.prnewswire.com/c/img/favicon.png/query-c2Q9MjAyNi0wNC0yMCZzbj1QSDM3NzAx?x-oss-process=image/auto-orient,1/interlace,1/resize,w_1440,h_1440/quality,q_95/format,jpg" original-src="https://imageproxy.pbkrs.com/https://edge.prnewswire.com/c/img/favicon.png/query-c2Q9MjAyNi0wNC0yMCZzbj1QSDM3NzAx"/> View original content to download multimedia:https://www.prnewswire.com/news-releases/following-pivotal-trial-fda-set-to-review-first-of-a-kind-vr-autism-therapy-302746375.htmlSOURCE Floreo</div></div>

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Floreo has submitted a De Novo request to the FDA for FloreoRx, a VR-based therapy for Autism Spectrum Disorder. This investigational device aims to support skill development in individuals with autism. The submission follows a pivotal trial demonstrating significant improvements in social communication skills among participants using FloreoRx compared to a control group. If authorized, FloreoRx could enhance access to effective autism therapy, addressing a critical need for families and clinicians. The trial involved 125 patients and showed high satisfaction rates among stakeholders, with no serious adverse events reported.

Following Pivotal Trial, FDA Set to Review First-of-a-Kind VR Autism Therapy