• Findings provide scientific insights into the contribution of small interfering RNA (siRNA) and therapeutic vaccination towards the HBV functional cure strategy

DURHAM, N.C. and BEIJING, Nov. 7, 2025 /PRNewswire/ — Brii Biosciences Limited (“Brii Bio,” or the “Company,” stock code: 2137.HK), a biotechnology company developing therapies to improve patient health across diseases with high unmet medical need, today announced the publication of results from its Phase 2 ENSURE study in the peer-reviewed journal Nature Medicine. The study evaluates the efficacy and safety of an siRNA, elebsiran, in combination with pegylated interferon alfa (PEG-IFNα), compared to PEG-IFNα monotherapy. Furthermore, this study evaluates the potential role of an HBV therapeutic vaccine, BRII-179, in identifying immunologically responsive patients and improving hepatitis B surface antigen (HBsAg) loss rates.

The article, titled “Elebsiran and PEG-IFNα for chronic hepatitis B infection: a partially randomized, open-label, phase 2 trial“, is now available online [link].

The ENSURE study was conducted in two parts in virally suppressed chronic HBV patients. In Part I (Cohorts 1-3), participants naïve to BRII-179 were randomized to receive 48 weeks of PEG-IFNα alone or in combination with elebsiran (200 mg or 100 mg administered every 4 weeks [Q4W]). In Part II (Cohort 4), participants previously treated with 9 doses of elebsiran and BRII-179 in a completed Phase 2 study (BRII-179-835-001) were categorized as BRII-179 anti-HBs responders or non-responders based on peak hepatitis B surface antibody (anti-HBs) levels (≥10 IU/L or <10 IU/L, respectively), and subsequently received 48 weeks of elebsiran (100 mg Q4W) plus weekly PEG-IFNα in the ENSURE study.

Key results from this publication include:

• Cohorts 1-3: At 24 weeks post-EOT, HBsAg loss was observed in 4 of 19 participants (21.1%) in Cohort 2 (elebsiran 200 mg + PEG-IFNα) and 6 of 18 participants (33.3%) in Cohort 3 (elebsiran 100 mg + PEG-IFNα), compared to 1 of 18 participant (5.6%) in Cohort 1 (PEG-IFNα monotherapy).
• Cohort 4: At 24 weeks post-EOT, HBsAg loss was observed in 9 of 31 participants (29.0%), with a notably higher response among BRII-179 anti-HBs responders (8/19, 42.1%) compared to non-responders (1/12, 8.3%). BRII-179 anti-HBs responders also achieved more rapid HBsAg reductions and HBsAg seroclearance compared to non-responders.
• Elebsiran and PEG-IFNα combination therapy was generally safe and well tolerated across all cohorts.

The randomized, active-controlled design of Cohorts 1-3 was a gold standard in validating the clinical benefit of elebsiran over PEG-IFNα monotherapy, providing an important benchmark for future development of siRNA towards HBV functional cure.

The novel design of Cohort 4 explored a patient response-guided treatment approach for more personalized decision-making, maximizing response rates in those most likely to benefit while avoiding unnecessary and lengthy treatments in others.

Other important observations are 1) participants previously treated with BRII-179 and elebsiran experienced faster decline and loss of HBsAg, suggesting that BRII-179 may prime the immune system for improved responsiveness to subsequent curative therapy; 2) 50% (4/8) of anti-HBs responders who achieved sustained HBsAg loss had baseline HBsAg levels exceeding 1,500 IU/mL when enrolled in the previous BRII-179-835-001 study, suggesting that BRII-179 may elicit anti-HBs responses in patients with high baseline HBsAg levels. With its favorable safety profile, BRII-179 could play a unique role in priming and enriching patients regardless of the baseline HBsAg levels, expanding the population eligible for future curative regimens.

“The ENSURE study was designed to provide much-needed clarity and to answer critical scientific questions about curative treatment for chronic hepatitis B,” said Professor Jidong Jia, lead principal investigator of the ENSURE study, “It is encouraging to see that the 24-week follow-up data remain consistent with the EOT results, substantiating the added clinical benefit of elebsiran and pointing to the potential new roles of BRII-179 in priming and enriching CHB patients for achieving higher cure rates. We look forward to validating these findings in confirmatory studies.”

About Hepatitis B

Hepatitis B virus (HBV) infection is one of the world’s most significant infectious disease threats with more than 254 million people infected globally.^[1] Chronic HBV infection is the leading cause of liver disease and an estimated 820,000 people die of complications from chronic HBV infection each year.^[1] HBV is of exceptional concern in China, where 87 million people are chronically infected.^[2]

About BRII-179

BRII-179 is a novel recombinant protein-based HBV immunotherapeutic candidate that expresses the Pre-S1, Pre-S2, and S HBV surface antigens, and is designed to induce enhanced and broad B-cell and T-cell immunity. In November 2023, the Center for Drug Evaluation (the “CDE”) of the National Medical Products Administration (the “NMPA”) granted BRII-179 Breakthrough Therapy Designation.

About Elebsiran

Elebsiran is an investigational subcutaneously administered HBV-targeting siRNA designed to degrade hepatitis B virus RNA transcripts and limit the production of hepatitis B surface antigen. It has the potential to have direct antiviral activity against HBV and HDV. It is the first siRNA in the clinic to include Enhanced Stabilization Chemistry Plus technology to enhance stability and minimize off-target activity, which potentially can result in an increased therapeutic index. Brii Bio licensed exclusive rights to develop and commercialize elebsiran for the Greater China territory from Vir Biotechnology, Inc. in 2020. In May 2024, the CDE of the NMPA granted elebsiran Breakthrough Therapy Designation.

About Brii Bio

Brii Biosciences Limited (“Brii Bio“, stock code: 2137.HK) is a biotechnology company developing therapies to address major public health challenges where patients experience high unmet medical needs, limited choice and significant social stigmas. With a focus on infectious diseases, the Company is advancing a broad pipeline of unique therapeutic candidates with lead programs against hepatitis B virus (HBV) infection. The Company is led by a visionary and experienced leadership team and has operations in key biotech hubs, including Raleigh-Durham, the San Francisco Bay Area, Beijing and Shanghai. For more information, visit www.briibio.com.

– Tickets and travel packages now available for global K-pop fans 

– “Play&Stay” package combines live performances with premium Korean travel experiences

SEOUL, South Korea, Nov. 7, 2025 /PRNewswire/ — interpark Global, a travel and ticketing platform operated by NOL Universe for international visitors, is inviting global fans to Korea this holiday season with exclusive access to two of the year’s most anticipated K-pop events — G-DRAGON’s encore concert and the SBS Gayo Daejeon. The platform will offer both ticket-only options and combined travel packages, introducing a new way for fans to experience K-culture through live performances and immersive travel. 

G-DRAGON’s “2025 WORLD TOUR [Übermensch] IN SEOUL: ENCORE” will take place from December 12 (Fri) to 14 (Sun) at Gocheok Sky Dome in Seoul. interpark Global will open ticket sales for international fans, providing both standard tickets and “Play&Stay” packages that include hotel accommodations. These packages allow visitors to enjoy a seamless premium experience combining live K-pop performances with Korean travel. Fan club pre-sales begin on November 10 (Mon) at 9 PM KST / 7 AM ET, followed by general sales on November 11 (Tue) at 8 PM KST / 6 AM ET.

interpark Global will also serve as a major partner for the “2025 SBS GAYO DAEJEON Winter,” taking place on December 25 (Thu) at Inspire Arena in Incheon. Featuring a star-studded first lineup including Stray Kids, TOMORROW X TOGETHER, ENHYPEN, IVE, and LE SSERAFIM, this year’s event — themed “Golden Loop” — will mark the grand finale of the 2025 K-pop season. interpark Global will offer exclusive “Play&Stay” packages that combine the special pre-show “Blue Carpet” session with shuttle service and hotel accommodations, providing fans with a unique on-site experience. K-culture travel packages are scheduled to go on sale in mid-November, and interpark Global members can also receive a ₩30,000 discount coupon for shuttle packages purchased through the end of November.

An interpark Global representative said, “This holiday season, we look forward to welcoming global fans to experience K-pop up close through interpark Global. We will continue expanding our services to help fans from around the world experience the vibrant energy of Korean culture firsthand through innovative travel-linked concert experiences.”

interpark Global serves over 7.6 million international users, offering ticketing for K-pop concerts, festivals, musicals, and other cultural events. The platform’s signature Play&Stay program bundles accommodations and transportation with live performance access, creating an integrated cultural tourism experience that strengthens Korea’s position as a global hub for entertainment. 

EL MONTE, Calif., Nov. 7, 2025 /PRNewswire/ — NAVEE, a fast-growing leader in electric mobility, today announced the launch of its all-new G5 Series Electric Scooter, featuring the G5, G5 Pro, and G5 Max, designed to deliver a more connected, more stable, and more inspiring commuting experience.

The G5 Series Electric Scooter showcases a futuristic diamond-cut frame paired with intelligent control systems and advanced suspension technology, combining modern aesthetics with precision engineering. Prices start at $549.99 for G5, $599.99 for G5 Pro, and $699.99 for G5 Max. The Max model is now available on NAVEE’s official online store, while other models will be gradually launched on the store and Amazon.

“With the G5 Series, we set out to redefine urban riding,” said Loong, Product Manager at NAVEE. “Every detail was designed to make riding smarter, safer, and more enjoyable.”

The G5 Series features NAVEE’s Advanced Traction Control System (TCS) for enhanced grip on wet or uneven surfaces, combined with dual suspension and 10-inch tubeless tires for a smooth and confident ride. The dual-braking system and IPX5 water resistance further ensure safety in all conditions.

Built with automotive-grade QSTE 420 high-strength steel, each scooter has passed static load tests supporting over 2,205 lbs (1,000 kg), demonstrating exceptional structural integrity and long-term durability.

In terms of range reliability, all G5 models were tested at 77°F(25°C) with a 165 lbs(75 kg) rider, traveling at an average speed of 9 mph(15 km/h) on flat pavement. Under these conditions, the G5 Max achieves up to 44 miles of range, offering dependable performance for daily commutes and longer weekend rides alike.

The G5 Max also brings a new level of intelligence to electric mobility with features such as Bluetooth proximity unlock, Apple Find My integration, and smart energy recovery, allowing riders to enjoy both performance and peace of mind on every journey.

Looking ahead, NAVEE plans to expand its intelligent ecosystem with more connected mobility solutions, integrating data, sustainability, and rider experience to shape the future of green transportation.

About NAVEE

NAVEE is a leading brand in electric mobility, recognized for its industry-leading suspension technology, and as the fastest-growing new brand in sales, delivering products with cutting-edge design and sustainability. Discover how NAVEE is shaping the next generation of smart urban mobility at https://naveetech.us/.

Japan’s newly appointed Foreign Minister Toshimitsu Motegi sparked an unexpected viral moment at APEC 2025 after stopping by Imunika — the official coffee sponsor of APEC 2025 Korea, a Korea–U.S. startup redefining “Wellness Specialty Coffee.”

SEOUL, South Korea and WASHINGTON, Nov. 7, 2025 /PRNewswire/ — A quiet exchange at the APEC 2025 Korea Summit became one of the event’s most unexpected stories. Toshimitsu Motegi, Japan’s newly appointed Foreign Minister — soon to help steer Japan–U.S. tariff negotiations — was filmed sampling Imunika, a small bio-fermented coffee startup that unexpectedly found global attention.

The clip, posted to Motegi’s official social-media account, drew over 4 million views, 60,000 shares, and 15,000 comments within 48 hours, softening his characteristically firm public image. In a follow-up interview, Motegi said, “I didn’t expect the video introducing the coffee to be viewed more than four million times.”

Founded in Korea and the US, Imunika created a disruptive innovation in coffee, representing a new wave of Wellness Specialty Coffee that blends Korea’s fermentation technique with Seattle’s specialty roasting profile. Through its patented bio-fermentation process, medicinal mushrooms are integrated with coffee beans, producing a smoother, lower-caffeine cup that supports immune health, gut balance, and mental clarity — what the company calls “Mushroom Coffee 2.0.”

“It was a completely serendipitous moment for us,” said Jinhu Park, Imunika’s Founder and CEO. “Imunika represents Korea’s wellness culture — each cup is meant as an investment in oneself, not a mere act of consumption. At APEC, it was humbling to see how naturally that idea resonated among the world’s leaders.”

The company’s story is rooted in a personal journey. Park, a Cornell-educated entrepreneur, began developing Imunika’s mushroom fermentation technique with his family after losing his younger brother to cancer in 2020 — turning that tragic experience into a mission to redefine the world’s most beloved beverage, coffee.

What began as a search for healing became a cup now connecting Korea, Japan, and the United States — proof that shared taste can sometimes achieve what diplomacy aims for.

About Imunika
Imunika is a premium wellness brand rooted in Korea’s fermentation heritage. Through a patented four-week bio-fermentation process and a proprietary seven-mushroom complex, Imunika crafts low-caffeine, immune-supporting whole-bean coffee made for decision makers and intention seekers

Website: www.imunika.com
Instagram: @imunika

HO CHI MINH CITY, Vietnam, Nov. 7, 2025 /PRNewswire/ — Saigon Technology announces a dual milestone: receiving the Great Place to Work® Certification 2025 and being recognized among the Top 10 ICT Companies in Vietnam by the Vietnam Software & IT Services Association (VINASA).

These achievements are proof of a long-term vision: to bring Vietnamese engineering talent to the world, while building a people-first culture and contributing to the growth of Vietnam’s ICT industry.

Vietnamese Talent on the Global Stage

Over the past 13 years, Saigon Technology has grown into a leading software development partner, with hundreds of engineers and three development centers across Vietnam. The company partners with clients in the United States, Canada, Europe, Australia, and Asia-Pacific, from startups to Fortune 500 enterprises.

Each project is about bridging cultures, mastering advanced technologies, and adapting quickly to client needs. This approach has made Saigon Technology a trusted offshore software development partner for U.S. companies seeking reliability, transparency, and innovation.

Building Skills, Sustaining Balance

To compete globally, engineers must be both highly skilled and resilient. Saigon Technology has created a strong talent development ecosystem, offering learning programs, mentorship, and internal contests to strengthen creativity and problem-solving.

At the same time, the company prioritizes employee well-being through flexible working policies, wellness programs, and open communication. Health check-ups, mental wellness sessions, and supportive leadership keep employees motivated even while working across multiple time zones like U.S. schedules.

This culture earned Saigon Technology the Great Place to Work® Certification 2025, with 97% positive employee feedback and 98% expressing pride in their workplace. 

“This certification is a powerful reflection of our values,” said Thanh Pham, CEO of Saigon Technology. “At Saigon Technology, we believe that true innovation emerges when our people flourish. Our mission goes beyond meeting international standards — we strive to cultivate a workplace where every individual feels valued, inspired, and deeply connected to our shared purpose of driving excellence and technological advancement.”

Recognition as a Top 10 ICT Company in Vietnam

Alongside workplace recognition, Saigon Technology was once again named among Vietnam’s Top 10 ICT Companies 2025, recognized in three key categories: Global Digital Services, AI Application Development Platforms, and Software Application Development.

The awards highlight the company’s strength in advanced technologies and its commitment to ISO 9001 and ISO 27001 standards. With clients across five continents, Saigon Technology demonstrates how Vietnamese tech talent can compete globally while offering agility and cost efficiency.

“Being recognized in VINASA’s Top 10 ICT is both an honor and a responsibility,” Mr. Thanh Pham added. “It reaffirms our role as a trusted global technology partner and our commitment to Vietnam’s growing position in the global ICT landscape.” 

A Vision Beyond Achievements

For Saigon Technology, awards mark only milestones in a continuing journey. The company’s broader vision is to position Vietnam as a global hub for software innovation and engineering excellence by investing in people, processes, and partnerships.

As part of this journey, the company has invested in TechTIQ Solutions Pte as a gateway for Vietnamese engineers to expand their reach into international markets and strengthen its presence across Asia and the U.S., bringing Vietnamese expertise to a broader stage.

“Our journey is not defined by awards alone,” Thanh Pham concluded. “It is defined by the impact we create for our clients, our people, and Vietnam’s technology future.”

About Saigon Technology

Founded in 2012, Saigon Technology is an award-winning software development company recognized among Vietnam’s Top 10 ICT Companies 2025 and certified as a Great Place to Work® 2025. The company specializes in custom software development, web and mobile app development, cloud solutions, and AI-powered services. 

With ISO 9001 and ISO 27001 certifications, hundreds of top-tier engineers, and offices in Vietnam, the USA, Australia, and Singapore, Saigon Technology partners with clients worldwide to deliver secure, scalable, and innovative solutions.

NEW YORK, Nov. 7, 2025 /PRNewswire/ — Ultra-Wideband (UWB) is rapidly becoming a foundational wireless connectivity technology, offering unique benefits compared with other short-range wireless solutions such as Wi-Fi, Bluetooth®, IEEE 802.15.4, and Near Field Communication (NFC). The combination of secure ranging, radar, and sensing capabilities, along with its potential to serve as a low-latency, high-throughput communications technology over short distances, is enabling an increasingly diverse set of use cases across consumer, automotive, commercial, industrial, and smart city environments. With next-generation UWB based on IEEE 802.15.4ab on the horizon, the technology will become even more compelling. As a result, global technology intelligence firm ABI Research expects UWB to be one of the fastest-growing wireless connectivity technologies, with device shipments forecast to grow at a 21% compound annual growth rate (CAGR) between 2025 and 2030.

“The UWB chipset and IP ecosystem has grown rapidly in recent years with the expansion of product portfolios, new entrants to the market, and a number of UWB-related acquisitions,” said Andrew Zignani, Senior Research Director. “ABI Research expects other vendors to enter the market, as well as the expansion of combo and multi-protocol UWB solutions, tailored solutions to specific market verticals, and unique combinations of UWB technology from a ranging, sensing, and data-communications perspective.”

“While this brings enormous potential opportunities, it also brings challenges in terms of standardization and interoperability, more direct competition with other technologies, the need to ensure future spectrum resources, and the creation of a compelling ecosystem of solutions that can support this growing heterogeneity of applications,” Zignani added.

More than 436 million UWB-enabled devices shipped in 2024, and ABI Research expects 27% of smartphones to ship with UWB technology in 2025, growing to over 52% by 2030. As smartphones act as central hubs for a wide range of applications, they will accelerate broader growth in the UWB market and ecosystem.

Much of UWB’s initial success has stemmed from secure ranging applications such as automotive digital keys and personal trackers. These are now extending to residential and commercial building access control, including UWB smart door locks and commercial access control readers. While secure ranging use cases are expected to dominate volumes—and unlock new opportunities in contactless payments and transportation ticketing—ABI Research also expects UWB to be increasingly leveraged for radar, sensing, and low-latency, high-throughput data communications, enabling a broader range of future use cases. Companies are already combining multiple benefits of UWB to create new solutions, such as automotive secure access with child presence detection, while wireless audio, low-latency high-speed links for peripherals, gaming devices, IoT, Extended Reality (XR), robotics, and wearables are also gaining traction.

“Different organizations and consortia will need to ensure that UWB can address all these future use cases while achieving performance, latency, and security requirements,” Zignani said. “In parallel, continued work is needed to create a favorable regulatory environment for UWB spectrum to strengthen the long-term viability of the technology across these applications.”

“UWB development is also contingent on a number of different standards organizations and consortia, including the IEEE, the UWB Alliance, the FiRa Consortium, the Connectivity Standards Alliance, the Car Connectivity Consortium, the Intelligent Car Connectivity Industry Ecosystem Alliance (ICCE), the Intelligent Car Connectivity Open Alliance (ICCOA), omlox, and the Audio Engineering Society (AES). In the longer term, collaboration between these organizations will benefit a wide range of solution providers, including CEVA, Qorvo, Qualcomm, NXP, STMicroelectronics, Infineon, Apple, Synaptics, SPARK Microsystems, Samsung, Calterah, MKSemi, GiantSemi, Renesas, Osemitech, and CXSemi, among many others.”

These findings are from ABI Research’s UWB Market Evolution: New Opportunities in Secure Ranging, Radar, and Data Communications report, part of the company’s Wi-Fi, Bluetooth & Wireless Connectivity research service, which includes research, data, and analyst insights.

About ABI Research

ABI Research is a global technology intelligence firm uniquely positioned at the intersection of technology solution providers and end-market companies. We serve as the bridge that seamlessly connects these two segments by providing exclusive research and expert guidance to drive successful technology implementations and deliver strategies proven to attract and retain customers.

ABI Research是一家全球性的技术情报公司，拥有得天独厚的优势，充当终端市场公司和技术解决方案提供商之间的桥梁，通过提供独家研究和专业性指导，推动成功的技术实施和提供经证明可吸引和留住客户的战略，无缝连接这两大主体。

For more information about ABI Research’s services, contact us at +1.516.624.2500 in the Americas, +44.203.326.0140 in Europe, +65.6592.0290 in Asia-Pacific, or visit www.abiresearch.com.

Contact Info: 

Global
Jason Scheer
Tel: +1.516.624.2558
pr@abiresearch.com

The WiSE-UP post-approval study is gathering real-world evidence from commercially treated patients using the WiSE® left ventricular endocardial pacing (LVEP) system.

Key Highlights:

• The first two patients have now been enrolled in the WiSE-UP post-approval study by Dr Devi Nair from St Bernards Heart & Vascular Center, Arkansas
• The EBR-sponsored study will evaluate real-world outcomes for heart failure patients receiving the FDA-approved WiSE® System for delivering LVEP in patients unable to receive traditional cardiac resynchronization therapy (CRT)
• The study will follow more than 300 patients across 50 US centers over a five-year period, and will generate both short- and long-term performance metrics

SUNNYVALE, Calif., Nov. 7, 2025 /PRNewswire/ — EBR Systems, Inc., developer of the world’s only wireless cardiac pacing system for heart failure, today announced the first patient enrollments in the WiSE® System Utilization & Performance (WiSE-UP) Study. The first two patients were treated at St. Bernards Heart & Vascular Center in Arkansas by Dr. Devi Nair, a globally recognized electrophysiologist.

This milestone marks an important step forward in advancing cardiac resynchronization therapy (CRT) for patients with heart failure with the addition of LVEP.

Sponsored by EBR Systems, the WiSE-UP Study is a prospective, observational post-approval study designed to evaluate real-world outcomes in patients treated with the FDA-approved WiSE System, which delivers left ventricular endocardial pacing (LVEP) for CRT. The study will follow more than 300 patients across 50 centers over five years, generating both short- and long-term performance data to inform future clinical practice.

“It was an honor to lead the team performing the first WiSE System implant as part of the WiSE-UP Study,” said Devi Nair, MD, FACC, FHRS, Electrophysiologist at St. Bernards Heart & Vascular Center. “Our entire team is proud to contribute to this important study, which we believe will further demonstrate the benefits of left ventricular endocardial pacing for patients with heart failure. We look forward to continuing our collaboration with EBR Systems as we work together to advance innovation in cardiac resynchronization therapy and improve patient outcomes.”

Niraj Varma, MD, PhD, FRCP, Professor of Medicine at the Cleveland Clinic and the National Principal Investigator for the study said: “The launch of the WiSE-UP Study marks an exciting moment in cardiac resynchronization therapy. This study will evaluate the application of left ventricular endocardial pacing in real world practice, capture important clinical outcomes over time, and assess sustained therapeutic impact of the WiSE System. I am proud to lead this initiative that will continue to develop the standards of care for heart failure patients.” 

For more information about EBR, please visit https://www.ebrsystemsinc.com/.  

About EBR Systems

EBR Systems is a cardiac rhythm management company on a clear mission: to transform the lives of people with heart failure by helping physicians deliver optimal cardiac pacing. The WiSE System—the first FDA approved system for leadless left ventricular endocardial pacing (LVEP) in CRT—combines advanced engineering with peer-reviewed clinical evidence to expand access for patients who previously lacked options and to improve outcomes.

About the WiSE Technology

The WiSE System delivers LV endocardial pacing without a transvenous LV lead using targeted ultrasound. A subcutaneous transmitter and battery detect the RV pacing signal and, within milliseconds, emit ultrasound energy that a rice-sized endocardial electrode converts into an electrical pulse—enabling synchronized biventricular pacing. This LVEP approach is engineered for versatility across patient anatomies and is supported by peer-reviewed outcomes from SOLVE-CRT pivotal trial. WiSE is approved for commercial use in the United States and limited to clinical study use outside of the United States.

Forward-Looking Statements

This announcement contains or may contain forward-looking statements that are based on management’s beliefs, assumptions, and expectations and on information currently available to management. Forward-looking statements involve known and unknown risks, uncertainties, contingencies and other factors, many of which are beyond the Company’s control, subject to change without notice and may involve significant elements of subjective judgment and assumptions as to future events which may or may not be correct.

All statements that address operating performance, events or developments that we expect or anticipate will occur in the future are forward-looking statements, including without limitation our expectations with respect to our ability to commercialize our products and achieve broad market adoption including our estimates of potential revenues, costs, profitability and financial performance; our ability to develop and commercialize new products; our expectations with respect to our clinical trials, including enrollment in or completion of our clinical trials and our associated regulatory applications and approvals; our expectations with respect to the integrity or capabilities of our intellectual property position.  These forward-looking statements are based on EBR Systems’ current expectations and inherently involve significant risks and uncertainties. EBR Systems’ actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of certain risks and uncertainties including those risks described in more detail in its most recently filed Annual Report on Form 10-K, Quarterly Report on Form 10-Q, and other documents on file with the SEC from time to time and available on the SEC’s website at www.sec.gov.

Management believes that these forward-looking statements are reasonable as and when made. You should not place undue reliance on forward-looking statements because they speak only as of the date when made. EBR does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. EBR may not actually achieve the plans, projections or expectations disclosed in forward-looking statements, and actual results, developments or events could differ materially from those disclosed in the forward-looking statements.

Foreign Ownership Restriction

EBR’s ASX-traded (ASX: EBR) CHESS Depositary Interests (CDIs) are issued in reliance on the exemption from registration contained in Regulation S of the US Securities Act of 1933 (Securities Act) for offers or sales which are made outside the US. Accordingly, the CDIs have not been, and will not be, registered under the Securities Act or the laws of any state or other jurisdiction in the US. The holders of EBR’s CDIs are unable to sell the CDIs into the US or to a US person unless the re-sale of the CDIs is registered under the Securities Act or an exemption is available. Hedging transactions with regard to the CDIs may only be conducted in accordance with the Securities Act.

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CHICAGO and SEOUL, South Korea, Nov. 7, 2025 /PRNewswire/ — Coreline Soft will introduce its groundbreaking chest AI platform AVIEW 2.0 at RSNA 2025 (November 30–December 4, Chicago), demonstrating how unified AI automation is fundamentally transforming radiology workflows and elevating diagnostic precision across pulmonary, cardiac, and airway pathologies.

AVIEW 2.0 represents a paradigm shift from task-specific tools to an integrated diagnostic ecosystem. The platform seamlessly combines lung-cancer screening (LCS), coronary-artery calcium scoring (CAC), and COPD quantification into a single, continuous analytical pipeline. Clinical validation shows radiologists achieve 89% faster case throughput and 60% reduction in interpretation time compared to the previous generation—effectively consolidating multi-disease CT assessment into one streamlined, automated workflow.

Global Validation: 2.5 Million Cases Across 19 Countries

AVIEW’s clinical foundation extends far beyond pilot studies. The platform has processed over 2.5 million cases across 19 countries, establishing itself as a proven solution in diverse healthcare ecosystems. Most notably, AVIEW has been adopted as the standard AI platform for lung cancer screening programs in major European nations—including Germany, France and Italy.

This shift reflects a global paradigm: AI is no longer viewed as a diagnostic aid but as essential medical infrastructure. With Germany and other EU countries now issuing guidelines that recommend AI as mandatory in lung screening workflows, the addressable market is poised for exponential expansion across Europe.

Real-World Validation in the U.S.

Beyond Europe, AVIEW solutions are already integrated into major U.S. medical centers, where their clinical reliability has been independently validated in real-world settings.

UMass Memorial Medical Center has deployed the system as an integrated platform for LCS, CAC, and COPD diagnosis, supporting full-spectrum thoracic screening in daily radiology operations. Meanwhile, Temple Lung Center, 3DR Labs and ImageCare Radiology have incorporated AVIEW products into their research and diagnostic environments-each adapting AI functions to site-specific workflows and physician preferences.

Together, these deployments demonstrate that AVIEW 2.0 is more than proof of concept; it is a platform that adapts to real-world hospital operations while meeting the rigorous clinical standards of leading U.S. institutions.

RSNA 2025: AI as Infrastructure

“We see RSNA 2025 as confirmation that AI’s value is no longer theoretical,” said James Lee, COO of Coreline North America. “When workflow efficiency and diagnostic safety advance together, AI stops being an add-on-it becomes infrastructure. AVIEW 2.0 embodies that transition, delivering not just automation, but a sustainable foundation for precision medicine at scale.”

With national-scale validation in Europe, clinical adoption across top-tier U.S. institutions, and 2.5 million cases processed globally, Coreline Soft is positioning AVIEW 2.0 as the new benchmark for AI-driven thoracic imaging-where efficiency, accuracy, and scalability converge.

Additionally, Coreline Soft will conduct an end-to-end AI workflow demonstration in the “Radiology Reimagined” demo zone at RSNA 2025, using real-world clinical scenarios. With AVIEW and HUB, the full pathway-from triage and interpretation to reporting and quality management-will be validated against standards such as IHE and FHIR, allowing attendees to experience the integrated flow firsthand.

Event: RSNA 2025, McCormick Place South Hall Level 3, Booth #4929
Date: November 30 – December 4, 2025
Learn more: https://www.corelinesoft.com/en/events/#contevnt