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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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Tradr to Ring Opening Bell at Cboe to Celebrate SpaceX ETF Launches

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Tradr ETFs will ring Cboe’s Opening Bell on June 15 to celebrate the launch of SPCM and SPCG, ETFs providing 200% leveraged long and short exposure to the newly public SpaceX stock.

Firm to commemorate the launch of SPCM and SPCG from the center of the world’s largest options trading floor

NEW YORK, June 14, 2026 /PRNewswire/ — Tradr ETFs, a provider of ETFs designed for sophisticated investors and professional traders, today announced that its team will ring the Opening Bell at Cboe Global Markets at 8:30 am on Monday, June 15, 2026. The ceremony, to be broadcast live on CNBC, will commemorate the expected start of trading for the Tradr 2X Long SpaceX Daily ETF (Cboe: SPCM) and the Tradr 2X Short SpaceX Daily ETF (Cboe: SPCG).

We’re excited to bring both bullish and bearish leveraged exposure to one of the market’s most closely watched stocks

SPCM and SPCG seek to provide traders with 200% leveraged bullish and bearish exposure to SpaceX (Nasdaq: SPCX), one of the most anticipated public offerings in market history.

“Few companies have captured the imagination of investors quite like SpaceX, and we’re proud to mark the launch of SPCM and SPCG by ringing the Opening Bell at Cboe,” said Russell Tencer, President of Tradr ETFs. “Cboe has been an outstanding partner to Tradr since our inception, and there is no better place to celebrate products built for traders by traders. We’re excited to bring both bullish and bearish leveraged exposure to one of the market’s most closely watched stocks and to do so from the center of the options trading world.”

Monday’s expected launch expands Tradr’s growing lineup of leveraged ETFs focused on the rapidly evolving space economy. The firm also offers the Tradr 2X Long ASTS Daily ETF (Cboe: ASTX) and the Tradr 2X Long FLY Daily ETF (Cboe: FLYT), providing 200% leveraged long exposure to two other closely watched companies helping shape the future of space-based communications and aerospace innovation.

Tradr’s lineup of 65 leveraged ETFs represents over $7 billion in assets under management. Some of its notable tickers on trending stocks include SNXX and SNDQ, which provide long and short exposure to SanDisk (SNDK). Tradr’s strategies can be accessed through most brokerage platforms and allow investors to avoid the hassle of using margin and the complexity of options trading. The firm continues its mission of providing sophisticated investors with innovative trading tools that enhance their ability to express market views with precision and efficiency.

For detailed information on Tradr ETFs and the significant risks involved with leveraged ETFs, please visit www.tradretfs.com.

About Tradr ETFs
Tradr ETFs are designed for sophisticated investors and professional traders who are looking to express high conviction investment views. The strategies include leveraged and inverse ETFs that seek short or long exposure to actively traded stocks and ETFs.

IMPORTANT RISK INFORMATION
Tradr ETFs are for sophisticated investors and professional traders with high conviction views and are very different from most other ETFs. The Funds are intended to be used as short-term trading vehicles and pursue leveraged investment objectives, which means they are riskier than alternatives that do not use leverage because the Funds magnify the performance of their underlying security. The volatility of the underlying security may affect a Fund’s return as much as, or more than, the return of the underlying security.

Investors in the fund should: (a) understand the risks associated with the use of leverage; (b) understand the consequences of seeking inverse and leveraged investment results; (c) for short ETFs, understand the risk of shorting; (d) intend to actively monitor and manage their investment. Fund performance will likely be significantly different than the benchmark over periods longer than the specified reset period and the performance may trend in the opposite direction than its benchmark over periods other than that period.

Leverage increases the risk of a total loss of an investor’s investment, may increase the volatility of the Funds, and may magnify any differences between the performance of the Funds and their reference security. The Funds seek leveraged investment results for a specific period (daily, monthly or quarterly). The exact exposure of an investment in the Fund intra-period will depend upon the movement of the reference security from the end of the prior period until the time of investment by the investor.

The Fund will not attempt to position its portfolio to ensure it does not gain or lose more than a maximum percentage of its net asset value on a given trading day. As a consequence, investors in a Fund that seeks two times daily performance would lose all of their money if the Fund’s underlying security moves more than 50% in a direction adverse to the Fund on a given trading day.

ETFs involve risk including possible loss of the full principal value. There is no assurance that the Fund will achieve its investment objective. Principal risks and other important risks may be found in the prospectus. Past performance does not guarantee future results.

ETF shares are bought and sold at market price (not NAV) and are not individually redeemed from the ETF. There can be no guarantee that an active trading market for ETF shares will develop or be maintained, or that their listing will continue or remain unchanged. Buying or selling ETF shares on an exchange may require the payment of brokerage commissions and frequent trading may incur brokerage costs that detract significantly from investment returns.

Investors should carefully consider the investment objectives, risks, charges and expenses of the Funds. This and other important information about the Fund is contained in the Prospectus, which can be obtained by visiting www.tradretfs.com. The Prospectus should be read carefully before investing.

Distributed by ALPS Distributors, Inc, which is not affiliated with AXS Investments or its Tradr ETFs. AXI000965

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SOURCE Tradr ETFs

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Changan Group Unveils Its In-house Developed ADAS — SDA Pilot

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CHONGQING, China, June 14, 2026 /PRNewswire/ — At the 28th Chongqing International Auto Exhibition, Changan Group showcased its full brand lineup including CHANGAN NEVO, CHANGAN DEEPAL and AVATR at Hall N8, and officially launched its self-developed Advanced Driver-Assistance System, SDA Pilot.

At the press conference, Zhu Huarong, Chairman of Changan Group, stated: “Changan will work together with partners and users worldwide to make ADAS better, more practical, and more accessible, protecting every journey with smart technology.” It is announced that the CHANGAN NEVO Q06 will come standard with SDA Pilot across all trim levels and hit its domestic market in the second half of 2026.

SDA Pilot Takes the Spotlight: Three-tier Safety Defenses Upgrade the ADAS Experience

As Changan’s latest technological achievement in smart mobility, SDA Pilot breaks the boundaries of traditional physical safety and establishes three comprehensive safety defense systems covering physical well-being, mental comfort and emotional interaction.

The entry-level SDA Pilot Pro comes standard with LiDAR, capable of identifying obstacles in low-light conditions such as at night or in tunnels two seconds faster than the human eye. Supported by the globally leading SDA Central Ring Network Architecture, the system cuts response time by an additional 150 milliseconds. SDA Pilot Max, leverages over 20 million high-quality real-world driving data segments for training, delivering exceptional perception and predictive capabilities to confidently navigate complex, high-frequency commuting scenarios. The top-tier SDA Pilot Ultra is integrated with the VLM (Vision Language Model), which greatly enhances the vehicle’s environmental perception and enables interactive advanced driver-assistance functions, turning the vehicle into an intuitive travel companion. In the future, an active driver incapacitation protection function will also be introduced to safeguard driving safety at the first moment.

While continuously evolving its ADAS user experience, Changan remains committed to its safety bottom line, clearly reminding: “Driver assistance is not autonomous driving. Drivers are still required to take on the core responsibilities of real-time monitoring and taking over control at any time.”

Advancing the “1445” Global Strategy: 17 Years of Intelligent R&D Build Solid Safety Foundations

Changan Group lives by the tenet of “Intelligence defines Changan.” As a core component of the “1445” Global Strategy that underpins four transformation priorities (The four priorities refer to: intelligent mobility, electrification, a unified ecosystem, and globalization), intelligent mobility stands as the primary driving force for Changan’s upgrading. The company is committed to building a world-class auto group with global competitiveness and independent core technologies, aiming to rank among the world’s top 10 automobile brands by 2030. The launch of SDA Pilot marks a landmark achievement of this strategy in the advanced driving-assistance sector.

Behind this technological breakthrough lies a solid intelligent foundation built by Changan over 17 years. Since establishing its intelligent R&D team in 2009, Changan has forged ahead in uncharted technological territories and built the China’s only national key laboratory dedicated to intelligent vehicle safety technology — CHANGAN SDA LAB. The lab supports round-the-clock global collaborative testing with more than 400,000 virtual simulation scenarios.

Over the past five years, more than 2,000 Changan engineers have completed over 5 million kilometers of real-road tests across Chongqing’s notoriously complex road conditions, covering 185 typical driving scenarios. Rich field experience has been embedded into the system, which keeps evolving based on user feedback and forms the unshakable safety strength of SDA Pilot.

Empowered by intelligent technologies, Changan continues to accelerate its global footprint. To date, the group has established 22 overseas manufacturing bases with an annual capacity of 350,000 vehicles, and 1,124 overseas sales outlets, covering 118 countries and regions, with 41 global models launched. In 2025, Changan’s overseas sales reached 637,000 vehicles, a year-on-year increase of 18.9%.

Since the start of 2026, Changan has made successive moves in its globalization strategy: launching the Vast Ocean Plan 2.0 during the AutoChina 2026 in Beijing, establishing four core principles: long-term development, localization, systematization, and responsible ESG practices; and more recently, partnering with the Portuguese Football Federation (FPF) to become the Official Global Partner of the Portugal National Football Team, using sports as a bond to deepen global user connections and brand engagement.

View original content to download multimedia:https://www.prnewswire.com/apac/news-releases/changan-group-unveils-its-in-house-developed-adas–sda-pilot-302799729.html

SOURCE Changan Group

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Kakunin Announces Cryptographic Compliance Shield for Google Gemini and OpenAI Agent Ecosystems

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SaaS Compliance Leader Launches First-Class SDK Integrations for Google Antigravity, OpenAI Swarm, and OpenAI Assistants API to Meet Strict MiCA and EU AI Act Standards.

LONDON, June 13, 2026 /PRNewswire-PRWeb/ — Kakunin, the leading compliance infrastructure platform for autonomous AI agents, today announced the release of first-class SDK integrations for Google Antigravity SDK, OpenAI Swarm, and the OpenAI Assistants API.

Autonomous agents are executing high-value, real-world tasks—but without strict boundaries, they represent a massive security risk,” said Palash Bagchi, Founder, at Kakunin.

As organizations move autonomous AI agents from sandboxes to production, securing the tools they run has become a critical operational hurdle. The new integrations allow developers to cryptographically secure and audit agent actions in real time, meeting the strict requirements of upcoming regulations like the EU AI Act and MiCA.

Preventing Agent Drift at the Tool Layer

Instead of relying on prompt engineering or system instructions—which are susceptible to jailbreaks—Kakunin secures agent tool execution at the cryptographic layer:

Pre-Flight Scope Verification: Validates that an agent possesses the required permission scope (e.g., trade.execute, file.write) before executing local code.Active-Agent Enforcement: Dynamically halts execution if the agent’s underlying X.509 certificate has been revoked or suspended.Tamper-Evident Auditing: Automatically logs session starts, prompts, responses, tool successes, and error anomalies.

Ecosystem Compatibility out of the Box

The new releases bring seamless, code-first integrations to the industry’s leading agent frameworks:

Google Antigravity SDK: Hook-based runtime protection that automatically secures Gemini-powered tool workflows.OpenAI Swarm: A lightweight class wrapper (KakuninSwarm) that dynamically gates multi-agent handoffs and task executions.OpenAI Assistants API: A polling-loop helper (handle_assistants_requires_action) that streamlines safety checks and tool output formatting in a single call.

Beyond these core OpenAI and Google environments, the new releases also extend Kakunin’s cryptographic shield to the broader agent development community. Out-of-the-box templates and shims are now available for LangChain (KakuninToolGuard), LlamaIndex (KakuninFunctionToolGuard), CrewAI (KakuninCrewAgent), and AutoGen (KakuninConversableAgent), alongside native middlewares for Next.js API routes and raw client libraries for Go, TypeScript, and Python.

“Autonomous agents are executing high-value, real-world tasks—but without strict boundaries, they represent a massive security risk,” said Palash Bagchi, Founder, at Kakunin. “By bringing cryptographic X.509 validation directly to Google’s and OpenAI’s agent loops, we are giving developers the peace of mind to deploy agents in highly regulated environments like fintech and healthcare.”

Availability

The new SDK integrations are available immediately:

Python Package: Available on PyPI via pip install kakunin.Playground Notebooks: Developers can test the integrations in 1-click via the official OpenAI Cookbook and Google Gemini Cookbook.Reference Samples: Available on the public Kakunin Samples Repository.

To learn more about securing your autonomous agent workflows, visit kakunin.ai/docs. or visit Conversational GTM for more enquiries.

Media Contact
Palash Bagchi, Immortal Reality PA LLC, 1 4125437290, ai@kakunin.ai, https://www.kakunin.ai/

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SOURCE Kakunin

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