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

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WASHINGTON, April 20, 2026 /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.

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.

“The clinical research continues to validate what clinicians and families are seeing every day: immersive VR can meaningfully support skill development for autistic learners,” said Vijay Ravindran, founder and CEO of Floreo. “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.”

Clinical Highlights Include:

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).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).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.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.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).Crossover Findings: Participants who initially received the VR control demonstrated improvements after transitioning to Floreo treatment, supporting the consistency of the observed treatment effect.Safety Profile: No serious adverse events were reported in the study, and observed adverse events were generally mild and transient.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%).

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.

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SOURCE Floreo

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As AI Speeds Up Marketing, Louisville’s RedTag Bets on Strategy

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Independent agency unveils new brand and website, and co-hosts Louisville’s PROOF AI Workshop

LOUISVILLE, Ky., Oct. 17, 2026 /PRNewswire/ — RedTag, an independent Louisville-based marketing agency, this month unveiled new positioning, marking its evolution from a digital performance agency into a strategy-first marketing partner. The move comes as AI makes execution faster than ever, and RedTag is betting that strategy, not speed, is what will set businesses apart. Clients can now choose from outcome-based programs that best fit their marketing needs. 

“Clients don’t come to us needing more tactics. They come to us needing a path,” said Russ Renbarger, founder and CEO of RedTag. “Our new brand says out loud what our work has shown for years: We start with strategy and build everything on that foundation.”

RedTag built its reputation on high-performing paid digital campaigns. Over the years, the agency expanded into strategy, creative, video production and website development, giving clients one partner for the full scope of their marketing. Most recently, a team of automation specialists has integrated AI across the agency to speed up production and analysis, guided by an internal AI policy that keeps people accountable for quality. The time AI saves goes back into strategy: knowing what to say, who to say it to and why.

“Our best client relationships have always been partnerships, where we’re in the room when the big decisions get made,” said Alison Conway, chief client officer at RedTag. “This evolution is about bringing that strategic partnership to every client.”

On Oct. 14, RedTag co-hosted the PROOF AI Workshop with Slingshot, Vsimple and Advanced Business Solutions. The hands-on event gave Louisville business leaders practical experience applying AI to their own work. RedTag led the event’s AI in Marketing and Branding track, with four sessions ranging from AI search optimization to a playbook for adopting AI across an organization.

“AI can produce hundreds of ads in an afternoon, but it can’t tell you which one your brand actually needs and why,” Renbarger said. “The faster the tools get, the more valuable human-led strategy becomes.”

RedTag was named the agency of record for the Commonwealth of Kentucky in 2025. Its client list includes PGA of America, Castle & Key Distillery, Bourbon Barrel Foods, ShopCaterpillar and American Beverage Marketers. Since 2023, RedTag’s work has received two Emmy Awards and more than 35 ADDY and AIGA awards. The agency is a four-time Louisville Business First Fast 50 honoree and was named one of the 2026 Best Places to Work in Kentucky.

To learn more about its outcome-based programs, visit RedTag Programs

About RedTag

RedTag is an independent, strategy-first marketing agency based in Louisville, Kentucky. Established in 2008, the agency starts every engagement by understanding the goal before recommending tactics. With a foundation rooted in discovery, RedTag delivers full-scale marketing campaigns built around each client’s business goals. RedTag serves organizations across hospitality, sports, agriculture, government, retail and consumer packaged goods. Learn more at redtag.agency.

View original content to download multimedia:https://www.prnewswire.com/news-releases/as-ai-speeds-up-marketing-louisvilles-redtag-bets-on-strategy-302911869.html

SOURCE RED TAG LLC

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The National Association of Mortgage Brokers Announces its Launch of MORE, New Mortgage Education and Professional Development Platform

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NAMB MORE brings training, credentials, professional development and daily mortgage market information together in one place

LAS VEGAS, Oct. 17, 2026 /PRNewswire-PRWeb/ — The National Association of Mortgage Brokers (NAMB) the first and only national volunteer-led and membership-driven organization representing the interests of mortgage brokers and home buyers since 1973, today announced the launch of NAMB MORE(Mortgage Originator Resources and Education), a new learning and professional development platform designed to give mortgage professionals the education, resources and information they need to grow throughout their careers.

MORE officially launches today during NAMB National 2026, being held October 16–19 at Caesars Palace in Las Vegas. The platform is designed as a long-term resource for mortgage professionals at every career stage, bringing training, credentials, professional development and timely industry information together in one place.

Mortgage professionals can learn more and access the platform at nambhasmore.org. Access to MORE will be free through NAMB Focus, January 7–9, 2027. Users must have a NAMB member profile to access the learning management system.

“NAMB MORE represents a significant investment in the future of mortgage professionals and the continued advancement of our industry,” said Michael Farrell, President of NAMB. “We wanted to create more than a collection of courses; we wanted to build a resource that professionals can turn to throughout their careers. NAMB MORE delivers valuable education, professional development and practical information members can apply to their businesses daily. ‘NAMB has MORE’ is a mantra the entire organization embraces, reflecting our commitment to providing the industry with innovative tools that support professional growth, strengthen advocacy and help foster our members’ success. “MORE was developed with the mortgage industry in mind, with NAMB and subject-matter experts contributing to the platform’s educational content.”

The platform is designed to support mortgage professionals from their first year in the business through experienced production, management and leadership roles. Educational resources span foundational mortgage knowledge, loan origination, mortgage programs and products, business growth, sales and marketing, borrower experience, professional development and more.

The MORE course library includes content across core categories such as:

Business Strategy & GrowthLoan OriginationMortgage FoundationsMortgage Programs & ProductsProfessional Development & Workplace SkillsSales, Marketing & Borrower ExperienceGeneral

Additional learning resources and credentials are designed to help mortgage professionals continue developing their skills as their careers evolve.

A key component of the new platform is the MORE Daily Dashboard, which serves as the home screen members see when they log into MORE. Rather than requiring members to visit the platform only when completing a course or pursuing a credential, the Daily Dashboard is designed to give mortgage professionals a reason to return every day.

The Daily Dashboard currently features:

Mortgage Rate Alert Widget: Provides information about the factors affecting mortgage rates and refreshes at least hourly.Upcoming Events: Highlights NAMB events and opportunities so members can stay connected to the association and industry.Daily Access to MORE: Provides a central starting point for accessing education, professional development and other resources.

“The Daily Dashboard is an important part of what makes MORE different,” added Farrell. “We want MORE to become part of a mortgage professional’s daily routine. Whether someone is checking the latest rate information, looking for an upcoming NAMB event or continuing their professional education, MORE puts useful resources in one place.”

About NAMB: The National Association of Mortgage Brokers has been the only national volunteer-led and membership-driven organization representing the interests of mortgage professionals and homebuyers since 1973. NAMB provides mortgage professionals with advocacy, education, and rigorous certification programs to recognize members with the highest levels of professional knowledge and education. NAMB’s active lobbying and advocacy efforts focus on national and state issues, protecting the interests of its members and borrowers. As the leading national trade association for the mortgage industry, NAMB is affiliated with state associations throughout the country and represents the interests of more than 546,800 licensed and registered Mortgage Loan Originators and 49,100 licensed Mortgage Broker and Mortgage Lender businesses throughout the U.S. www.namb.org

Media Contact

Joshua Steinfeld, Steinfeld Consulting, 1 339-225-1581, steinfeldconsulting@gmail.com

View original content:https://www.prweb.com/releases/the-national-association-of-mortgage-brokers-announces-its-launch-of-more-new-mortgage-education-and-professional-development-platform-302910967.html

SOURCE The National Association of Mortgage Brokers

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The United States Golf Association Selects Gupta Media as Paid Media Agency of Record

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The appointment comes as the USGA looks to continue to strengthen brand equity and increase awareness and engagement with golfers nationwide

BOSTON, Oct. 17, 2026 /PRNewswire-PRWeb/ — The USGA, the non-profit governing body of golf in the United States, has named Gupta Media its paid media agency of record following a competitive pitch process that began in February. Gupta Media will lead paid media strategy, planning, buying and reporting in support of the USGA’s Championship ticketing and broader commercial initiatives, while helping grow brand equity, awareness and engagement across the organization. Its work will span key USGA priorities, including golf’s official Handicap Index® and GHIN app; the Rules of Golf and the USGA’s governance of the game; Membership; and initiatives that advance golf through sustainability, research and innovation, and greater access and inclusion. The relationship expands beyond media execution to include audience strategy, first-party data integration, measurement and optimization.

“Gupta Media stood out for its ability to connect the dots between data, audience strategy, media and creative to real business outcomes, so we’re incredibly excited for this next chapter.”

The relationship comes at an important moment for the USGA, with the organization focused on continuing to expand its reach and deepening brand affinity across the ever-growing, diverse golf community. Gupta Media will help drive ticket sales for some of the sport’s biggest events, including the 2027 U.S. Open at Pebble Beach Golf Links, the 2027 U.S. Women’s Open at Inverness Club, the 2028 U.S. Open at Winged Foot Golf Club and the 2028 U.S. Women’s Open at Oakmont Country Club. The agency will also support the USGA in creating greater awareness and brand recognition for its corporate Partners through co-branded content and paid media.

Golf has an enormous network of people who love the game, creating a growing opportunity to build a deeper, more direct relationship between golfers and the organization. That challenge is exactly what Gupta Media is built to strategically address — from growing membership and promoting ticket sales for major live events to reaching new audiences and understanding customer lifetime value. By bringing together audience insights, first-party data and media performance, Gupta Media will help the USGA create more relevant, effective marketing that drives measurable business results while strengthening its connection with the next generation of golfers.

“We were looking for an agency that could bring a deep understanding of our audiences, a genuine enthusiasm for our mission and the strategic expertise to work with us through this next phase of golf’s growth,” said Lynn LaRocca, USGA’s Managing Director of Brand & Marketing. “Gupta Media stood out for its ability to connect the dots between data, audience strategy, media and creative to real business outcomes, so we’re incredibly excited for this next chapter.”

“There’s a personal element to this partnership that makes it especially rewarding. My golf journey began 30 years ago when I first visited Pebble Beach as a teenager, long before I could imagine actually playing on the course,” said Gogi Gupta, Founder, Gupta Media. “To now have the opportunity to connect that lifelong passion for the game with the work we’ve spent years building and fine-tuning our agency to do feels like kismet. We’re eager to bring our proficiency to an organization that plays a leading role in the great game.”

The relationship brings together Gupta Media’s deep experience in sports marketing with its data-driven approach to audience strategy, media and creative. The agency has developed a specialized set of tools and processes to address data and analytics challenges of sports and live events, including TallyTickets.com, its proprietary ticketing analytics platform that helps teams understand sales trends, forecast demand and make more informed marketing and media decisions. Gupta Media’s experience spans sports, entertainment, premium events, and pop culture, giving the agency a comprehensive understanding of the audience models and fan behaviors that shape the industry.

About the USGA:

The USGA is a mission-based golf organization whose purpose is to unify the golf community through handicapping and grassroots programs; to showcase the game’s best talent through the U.S. Open, U.S. Women’s Open, and 13 other national championships and our museum; to provide unbiased global governance with The R&A through the playing, equipment and Amateur Status rules; and to advance issues important to golf’s future, with a focus on driving sustainability.

About Gupta Media:

Gupta Media, a certified Minority Business Enterprise, is a strategic consultancy at the intersection of creative strategy, digital media, advanced analytics, and performance marketing. We drive growth for professional sports franchises, global tech leaders, DTC brands, major music labels, and other high-profile organizations by building intelligent media plans, best-in-class reporting tools, and custom enterprise technology. Founded 25 years ago by Cornell grad Gogi Gupta, the agency is known for developing new methods of maximizing advertising efficiency in a digital-first world. Harvard Business School’s case study on Gupta Media was taught to all incoming students for three years and is still taught around the globe.

Media Contact

Carly Carioli, Gupta Media, 1 617-682-3733, ccarioli@guptamedia.com, guptamedia.com

View original content:https://www.prweb.com/releases/the-united-states-golf-association-selects-gupta-media-as-paid-media-agency-of-record-302911621.html

SOURCE Gupta Media

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