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NEXTBIOMEDICAL Announces First Patient Enrolled in U.S. FDA Pivotal Trial of Nexsphere-F™ for Knee Osteoarthritis Pain

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  • RESORB Study Marks Major Step Toward U.S. Regulatory Approval and Global Commercialization

SEOUL, South Korea, Oct. 13, 2025 /PRNewswire/ — NEXTBIOMEDICAL CO., LTD. (KOSDAQ: 389650), an innovative medical device company based in South Korea, today announced the enrollment of the first patient in its U.S. pivotal clinical trial evaluating Nexsphere-F™, the company’s novel fast resorbable microsphere for musculoskeletal pain embolization. This milestone represents a significant advancement in NEXTBIOMEDICAL’s U.S. regulatory pathway, following FDA approval of its Investigational Device Exemption (IDE). The pivotal trial, known as RESORB (Randomized Controlled Study Evaluating Genicular Artery Embolization Against Intra-Articular Corticosteroid Knee Injection for Osteoarthritic Knee Pain), will enroll approximately 126 patients across more than 10 leading U.S. clinical sites. The study is designed to compare genicular artery embolization (GAE) with Nexsphere-F™ to intra-articular corticosteroid injections, with the primary goal of assessing both safety and efficacy in patients with painful knee osteoarthritis. Nexsphere-F™ has already received multiple key U.S. regulatory designations, including FDA Breakthrough Device Designation, CMS IDE Category B approval, and participation in the TAP (Total Product Lifecycle Advisory Program). These designations enable accelerated review and Medicare coverage during the clinical trial phase, underscoring the potential of Nexsphere-F™ to address a major unmet need in osteoarthritis treatment.

Beyond the U.S., Nexsphere-F™ has obtained CE-MDD certification in Europe and is currently used in real-world clinical practice across multiple countries. Results from 155 patients treated with Nexsphere-F™ were recently published in the Journal of Vascular and Interventional Radiology (JVIR), demonstrating a 67% average pain reduction at 6 months, with no device-related serious adverse events reported. A separate study published in the Orthopaedic Journal of Sports Medicine (OJSM) highlighted the safety and potential of transcatheter arterial embolization for patellar tendinopathy (jumper’s knee). At CIRSE 2025 in Barcelona, German key opinion leaders and Dr. Yuji Okuno of Japan presented real-world clinical cases further reinforcing the strong safety and efficacy profile of Nexsphere-F™ across diverse musculoskeletal conditions.

“The enrollment of the first patient in the RESORB trial marks an important milestone in our U.S. regulatory strategy,” said Ziv J. Haskal, MD, Professor at the University of Virginia and CMO(Chief Medical Officer) of NEXTBIOMEDICAL. “With CE-MDD approval in Europe, thousands of successful procedures worldwide, and a growing body of peer-reviewed evidence through JVIR, OJSM, and international presentations, we are confident this pivotal study will pave the way for FDA approval and broader global adoption of our technology.”

Reflecting the accelerating market adoption, NEXTBIOMEDICAL reported that overseas sales in Q3 2025 increased by approximately 40% compared to Q2 2025, highlighting strong commercial traction for Nexsphere-F™.

The device leverages an innovative resorbable microsphere technology designed to temporarily occlude abnormal blood flow in pain-inducing vessels. The microspheres naturally dissolve within 2–6 hours, inducing targeted necrosis of nerve endings responsible for osteoarthritis pain and delivering rapid, sustained pain relief. With the initiation of the U.S. pivotal trial, continued clinical expansion in Europe, and strong commercial growth, NEXTBIOMEDICAL is advancing its mission to deliver a paradigm-shifting solution for musculoskeletal pain management and accelerating its path toward global commercialization.

 

iRegene Therapeutics announced promising NouvNeu001 Phase I clinical data

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CHENGDU, China, Oct. 13, 2025 /PRNewswire/ — iRegene Therapeutics Co., Ltd. (“iRegene” or the “Company”) is recognized as a biotechnology company pioneering chemically induced allogeneic cell therapy. iRegene’s lead product, NouvNeu001, is the 1st iPSC therapy to receive IND approval from both the NMPA and the FDA to treat Parkinson’s disease (PD). Recently, NouvNeu001 Phase I clinical data were presented at the International Congress of Parkinson’s Disease and Movement Disorders (MDS).

Excellent safety and tolerability were observed for up to 15 months post-transplantation, notably without the use of immunosuppressants after the sixth month. NouvNeu001 was administered via a stereotactically guided procedure, with bilateral injections into the posterior putamen through a single injection trajectory per hemisphere. PET imaging confirmed the long-term engraftment, survival and maturation of the transplanted cells. Significant clinical efficacy was observed, including marked improvements in MDS-UPDRS Part III motor scores. In the low-dose cohort, UPDRS-III scores improved by an average of 30.6 points in the OFF state (a 52.82% improvement from baseline) and 12.9 points in the ON state (a 54.67% improvement from baseline）at 12 months post-transplantation. Similarly, in the high-dose cohort, scores decreased by an average of 23.3 points (OFF) and 9.67 points (ON) at 9 months post-transplantation. These improvements were statistically significant, with continued improvement observed through 15 months post-treatment.

Dr. Meng Cai, Chief Medical Officer of iRegene Therapeutics, explained why the Phase I results of NouvNeu001 are so promising. He stated:

“The encouraging outcomes from the Phase I trial of NouvNeu001 can be attributed to iRegene’s unique chemical induction platform and optimized clinical strategies. iRegene uses a proprietary chemical inducer cocktail to generate high-purity A9 dopaminergic progenitor cells with enhanced functionality. In addition, the surgical procedure was specifically designed to utilize a single injection trajectory per hemisphere, significantly reducing potential surgical risks and related adverse events.”

Dr. Jun Wei, Chief Executive Officer of iRegene Therapeutics, added:

“The iRegene team is greatly encouraged by this important milestone. We remain fully committed to advancing the completion of the Phase II clinical trial and the international multi-center Phase I clinical trial，and achieving the next milestones in our mission to bring transformative therapies to patients with Parkinson’s disease.”

About NouvNeu001

iRegene’s flagship product, NouvNeu001, is the world’s first clinical-stage, iPSC-derived, allogeneic dopaminergic progenitor cell therapy for PD. NouvNeu001 received the China NMPA’s IND clearance to initiate Phase I/II in China on Aug 2023, and received the FDA IND clearance to initiate Phase I in USA on June 2024. In April 2025, iRegene launched a multicenter Phase II clinical trial in China (NCT06167681).

On August 15, 2025, NouvNeu001 was granted Fast Track Designation (FTD) from the U.S. FDA, becoming the first allogeneic iPSC-derived PD cell therapy worldwide to earn this recognition. This milestone follows the FDA’s Special Exemption (SE) granted in March 2024, further validating iRegene’s clinical data integrity, product quality system, and innovative therapeutic approach.

About iRegene Therapeutics

Founded in 2017 by a team of international professionals, iRegene Therapeutics is the earliest biotech in the world to apply ” Chemical induction” to precisely reprogram cell fate and optimize cellular functions. Leveraging this breakthrough platform, iRegene Therapeutics has built a robust pipeline targeting currently “incurable” diseases such as Parkinson’s disease and blindness. As a leader in chemical induction, iRegene’s proprietary system enables the efficient easy generation of human specific cell types with high purity, and enhanced cellular functionality, pioneering the next generation of chemically derived cell therapies.

WiMi Studies Quantum Dilated Convolutional Neural Network Architecture

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BEIJING, Oct. 13, 2025 /PRNewswire/ — WiMi Hologram Cloud Inc. (NASDAQ: WiMi) (“WiMi” or the “Company”), a leading global Hologram Augmented Reality (“AR”) Technology provider, today announced that active exploration is underway in the field of Quantum Dilated Convolutional Neural Networks (QDCNN) technology. This technology is expected to break through the limitations of traditional convolutional neural networks in handling complex data and high-dimensional problems, bringing technological leaps to various fields such as image recognition, data analysis, and intelligent prediction.

The traditional Convolutional Neural Network (CNN) is a cornerstone in the field of deep learning. Through a combination of convolutional layers, pooling layers, and fully connected layers, it can automatically extract features from large amounts of data. In the convolutional layer, the convolution kernel slides over the input data, performing convolution operations to extract local features. The pooling layer reduces the data dimensions through downsampling, lowering computational load while preserving key information. The fully connected layer integrates the features processed by convolution and pooling, outputting the final classification or prediction results. However, with the explosive growth of data volume and the increasing complexity of problems, traditional CNNs are gradually facing bottlenecks in computational efficiency and feature extraction capabilities.

Quantum computing introduces the concept of quantum bits (qubits). Unlike the binary bits of traditional computers, qubits can exist in multiple superposition states, endowing quantum computers with powerful parallel computing capabilities. The Quantum Dilated Convolutional Neural Network (QDCNN) technology explored by WiMi ingeniously integrates the advantages of quantum computing into the traditional CNN architecture. In QDCNN, certain computational operations are performed by quantum processors. For example, in convolution operations, quantum gate operations are used to perform quantized computations on the convolution kernel and input data, enabling simultaneous processing of multiple data states, which significantly accelerates the feature extraction process. Quantum entanglement properties are also utilized to enhance information transfer and collaborative processing capabilities between different nodes in the network, allowing the network to more efficiently capture complex relationships within the data.

Through dilated convolution technology, the receptive field of the convolution kernel is expanded, enabling the acquisition of broader contextual information without increasing the number of parameters. This is highly effective for processing data with long-distance dependencies, such as natural language text and large-scale images. In Quantum Dilated Convolutional Neural Networks (QDCNN), quantum computing further enhances the effect of dilated convolution. Quantum algorithms can more precisely calculate the weight coefficients in dilated convolution, allowing the network to more accurately model complex features while expanding the receptive field. Traditional CNNs experience exponential growth in computational load when processing large-scale data. In contrast, QDCNN leverages the parallelism of quantum computing to complete convolution operations on massive datasets in a short amount of time.

Quantum Dilated Convolutional Neural Networks not only extract the features that traditional CNNs can obtain but also uncover hidden quantum-level feature information in the data. The superposition and entanglement states of quantum computing enable the network to analyze data from multiple perspectives simultaneously, identifying subtle feature differences that are difficult to detect with traditional methods. Due to quantum computing’s ability to explore a larger data feature space, the models built by QDCNN exhibit stronger generalization capabilities. When faced with new, unseen data, QDCNN models can better adapt and predict, reducing the occurrence of overfitting.

Achieving efficient collaboration between quantum computing and classical computing is a major challenge for QDCNN. In the future, WiMi will optimize the data transmission and task scheduling mechanisms between quantum computing and classical computing, rationally allocating computational tasks to allow quantum processors to focus on parts where quantum acceleration is significant, while classical processors handle traditional computational tasks, thereby improving the overall operational efficiency of the system. Additionally, WiMi will reduce algorithm complexity by optimizing algorithm structures, adopting layered designs, and implementing modular programming. At the same time, research into distributed quantum computing technology will enable quantum computing tasks to be distributed across multiple quantum processors for parallel processing, enhancing the scalability of QDCNN and making it capable of meeting the demands of large-scale data processing and complex application scenarios.

With continuous exploration and innovation in Quantum Dilated Convolutional Neural Network technology, it is expected to find wide applications in more fields. For example, in the medical field, Quantum Dilated Convolutional Neural Network technology can be used for molecular structure analysis and disease prediction in drug development, accelerating the process of new drug discovery and improving healthcare standards. In the field of intelligent transportation, it can enable more accurate traffic flow prediction and intelligent driving decisions, enhancing traffic safety and efficiency. In environmental protection, it can analyze large amounts of environmental data to predict climate change trends, providing strong support for formulating environmental policies.

About WiMi Hologram Cloud

WiMi Hologram Cloud Inc. (NASDAQ: WiMi) focuses on holographic cloud services, primarily concentrating on professional fields such as in-vehicle AR holographic HUD, 3D holographic pulse LiDAR, head-mounted light field holographic devices, holographic semiconductors, holographic cloud software, holographic car navigation, metaverse holographic AR/VR devices, and metaverse holographic cloud software. It covers multiple aspects of holographic AR technologies, including in-vehicle holographic AR technology, 3D holographic pulse LiDAR technology, holographic vision semiconductor technology, holographic software development, holographic AR virtual advertising technology, holographic AR virtual entertainment technology, holographic ARSDK payment, interactive holographic virtual communication, metaverse holographic AR technology, and metaverse virtual cloud services. WiMi is a comprehensive holographic cloud technology solution provider. For more information, please visit http://ir.wimiar.com.

Translation Disclaimer

The original version of this announcement is the officially authorized and only legally binding version. If there are any inconsistencies or differences in meaning between the Chinese translation and the original version, the original version shall prevail. WiMi Hologram Cloud Inc. and related institutions and individuals make no guarantees regarding the translated version and assume no responsibility for any direct or indirect losses caused by translation inaccuracies.

MediaGo Joins IAB UK to Empower a Transparent Advertising Ecosystem with Deep Learning

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SAN FRANCISCO, Oct. 13, 2025 /PRNewswire/ — MediaGo, an intelligent advertising platform, today announced its official membership with IAB UK, the leading industry body for the UK’s digital advertising industry. This milestone follows MediaGo’s certification as an official vendor of IAB Europe’s Transparency and Consent Framework (TCF), underscoring its long-standing commitment to compliance and transparency within the European market. By joining IAB UK, MediaGo expands this commitment locally, strengthening its role in the UK’s digital advertising governance and ecosystem development.

As part of the global IAB network, IAB UK unites more than 300 leading media owners, brands, platforms, agencies, and technology firms dedicated to fostering a sustainable digital advertising future.

As a member of IAB UK, MediaGo will gain valuable opportunities to engage with industry leaders, contribute to the development of industry standards, and access cutting-edge market insights. This membership will also facilitate direct connections with top UK brands and agencies, opening doors for new business collaborations and partnerships.

MediaGo remains focused on delivering tangible advertiser value through technological innovation. Its upgraded bidding solution, SmartBid 3.0, empowers advertisers with stable budget management and conversion optimization.

With access to premium global media inventory, MediaGo connects advertisers to high-quality traffic across Europe, North America, Japan, and South Korea. The platform strictly adheres to GDPR requirements in Europe and has secured re-certification by TrustArc in 2025 for its GDPR compliance. MediaGo prioritizes user data privacy, leveraging advanced brand safety features and transparent data practices to provide secure, trustworthy solutions for its clients.

“MediaGo is honored to join IAB UK as a member,” said Catelyn Wang, Director of Global Business Development and Sales at Baidu Global Business Unit. “IAB UK plays a crucial role in advancing compliance and innovation in the UK and worldwide digital advertising ecosystem. We look forward to collaborating closely with the bureau and its members to bring MediaGo’s expertise in intelligent advertising and global expansion to the UK market and to jointly promote a sustainable advertising ecosystem.”

Moving forward, MediaGo will actively fulfill its responsibilities as an IAB UK member. The platform will leverage the IAB UK network to deepen its ties with UK clients and partners, continuously delivering advertising solutions marked by enhanced transparency and efficiency, to help brands achieve sustained growth in the global market.

About MediaGo

MediaGo is a leading intelligent advertising platform. Based on deep learning algorithms, MediaGo empowers businesses of all scales, creating tangible value for companies. With 12 operational centers worldwide, MediaGo has successfully provided localized and comprehensive business growth services to over 10,000 partners.

NYSE Content Advisory: Pre-Market Update + LA Times Media Group takes step towards trading debut

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NEW YORK, Oct. 13, 2025 /PRNewswire/ — The New York Stock Exchange (NYSE) provides a daily pre-market update directly from the NYSE Trading Floor. Access today’s NYSE Pre-market update for market insights before trading begins. 

 

NYSE_Market_Update_Oct_13

Kristen Scholer delivers the pre-market update on October 13th

  • The Los Angeles Times Media Group took a step towards trading on the NYSE last week. The group opened a private placement opportunity to be followed by a potential IPO.
  • Dr. Patrick Soon-Shiong, Chairman and CEO of the group, said at the NYSE that he plans to build a media company for the future.
  • Stocks are rebounding Monday morning after President Trump said trade relations with China “will all be fine.” Trump suggested on Sunday that he may not follow through on his threat of a massive increase of tariffs.
  • The U.S. government remains shut down, limiting the release of economic data. The bond market is closed today, although equity trading does resume on the NYSE.
  • The National Association of Corporate Directors convenes in Washington D.C today to strategize on tackling pressing issues facing companies.

Opening Bell
FactSet (NYSE: FDS) celebrates newly appointed CEO Sanoke Viswanathan

Closing Bell
Columbus Citizens Foundation rings the Opening Bell

Click here to download the NYSE TV App

 

Collaboration across Bybit, DigiFT and UBS uMINT expands Collateral Solution for Institutions

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DUBAI, UAE, Oct. 13, 2025 /PRNewswire/ — Bybit, the world’s second-largest cryptocurrency exchange by trading volume, announced a strategic collaboration with DigiFT to support UBS’s USD Money Market Investment Fund Token (UBS uMINT), a token corresponding to the first tokenized investment fund launched by UBS Asset Management. Through this collaboration, Bybit will enable the shares of UBS’s tokenized money market investment fund, which are distributed via DigiFT, to be used as collateral on its platform for trading. This initiative marks a significant milestone in Bybit’s mission to connect traditional finance (TradFi) with the digital asset economy.

Issued by UBS Asset Management, the UBS uMINT is a money market investment built on the Ethereum public blockchain. Opened to external investors in November 2024, the UBS tokenized money market investment fund is distributed through authorized distribution partners. DigiFT, a licensed real-world assets (RWA) smart contract-based platform regulated by the Monetary Authority of Singapore and the Hong Kong Securities and Futures Commission, is at present the largest distributor by volume of the UBS tokenized money market investment fund.

“DigiFT is an innovator in regulated blockchain distribution,” said Ben Zhou, Co-Founder and CEO of Bybit. “By working together, we are opening the door for more traditional institutions to unlock further utility from their tokenized money market products. Through the collaboration with Bybit, investors of the UBS tokenized money market investment fund will be able to use their holdings as collateral for trading in a secure and cost-efficient way. This partnership is another important step in bridging Web2 finance and Web3 innovation.”

Yoyee Wang, Head of Bybit’s B2B Business Unit at Bybit, added: “Our B2B team is dedicated to leading key initiatives in loans, custody, and strategic partnerships that enable institutions to safely and seamlessly integrate digital assets into their operations. Collaborating with DigiFT gives our institutional clients access to a high-quality, regulated product backed by one of the world’s most trusted financial brands, while benefiting from Bybit’s robust settlement and liquidity infrastructure.”

“As a regulated, smart contract-based, non-custodial RWA distributor, DigiFT’s vision has always been to make high-quality investment products accessible on-chain without compromising compliance. Through this collaboration, DigiFT exemplifies how regulated RWA infrastructure can deliver both capital efficiency and transparency to the financial markets of the future,” added Henry Zhang, Founder & Group CEO of DigiFT.

This collaboration strengthens Bybit’s B2B and institutional service portfolio, supporting its strategy to onboard more traditional financial institutions into the digital asset space. By supporting regulated tokenized products such as UBS Asset Management’s tokenized money market investment fund and integrating the UBS uMINT token via DigiFT, Bybit continues to set new benchmarks for trust, transparency, and innovation in Crypto-TradFi integration.

Collaboration across Bybit, DigiFT and UBS uMINT expands Collateral Solution for Institutions
Collaboration across Bybit, DigiFT and UBS uMINT expands Collateral Solution for Institutions

#Bybit / #TheCryptoArk  

About Bybit
Bybit is the world’s second-largest cryptocurrency exchange by trading volume, serving a global community of over 70 million users. Founded in 2018, Bybit is redefining openness in the decentralized world by creating a simpler, open and equal ecosystem for everyone. With a strong focus on Web3, Bybit partners strategically with leading blockchain protocols to provide robust infrastructure and drive on-chain innovation. Renowned for its secure custody, diverse marketplaces, intuitive user experience, and advanced blockchain tools, Bybit bridges the gap between TradFi and DeFi, empowering builders, creators, and enthusiasts to unlock the full potential of Web3. Discover the future of decentralized finance at Bybit.com.

For more details about Bybit, please visit Bybit Press
For media inquiries, please contact: media@bybit.com
For updates, please follow: Bybit’s Communities and Social Media

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Expo 2025 Osaka draws to a close today: Koelnmesse welcomed three million visitors to the award-winning German Pavilion

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  • German Pavilion “Wa! Germany” closes after 184 days with over three million visitors
  • Koelnmesse, as the organisation responsible for operations, reports resounding success

COLOGNE, GERMANY and OSAKA, JAPAN – Newsaktuell – 13 October 2025 – After 184 days, the German Pavilion “Wa! Germany” at Expo 2025 in the Japanese city of Osaka has closed its doors. More than three million people from around the world visited the pavilion during this time, and it has now been recognised with two awards from the Bureau International des Expositions (BIE) – the Sustainability Award and the Silver Award for Theme Development. Koelnmesse GmbH, commissioned by the Germany’s Federal Ministry for Economic Affairs and Energy (BMWE) to organise and operate the German Pavilion, reports a resounding success.

View of the German Pavilion at Expo Osaka, with the iconic ring structure in the background. Photo credit: Jakob Studnar/Koelnmesse
View of the German Pavilion at Expo Osaka, with the iconic ring structure in the background. Photo credit: Jakob Studnar/Koelnmesse

“The German Pavilion has demonstrated impressively how large-scale international projects made in Germany can captivate audiences worldwide,” said Gerald Böse, CEO of Koelnmesse GmbH. “The BIE’s awards are a special acknowledgement of the concept, the outstanding teamwork of all those involved – and clear proof that Koelnmesse continues to set benchmarks in international competition.”

Koelnmesse CEO Gerald Böse at the German Pavilion at Expo 2025 in Osaka, Japan. For more than three decades, Koelnmesse has organized and operated German Pavilions at World Expos held under the auspices of the Bureau International des Expositions (BIE) on behalf of the Federal Ministry for Economic Affairs.
Koelnmesse CEO Gerald Böse at the German Pavilion at Expo 2025 in Osaka, Japan. For more than three decades, Koelnmesse has organized and operated German Pavilions at World Expos held under the auspices of the Bureau International des Expositions (BIE) on behalf of the Federal Ministry for Economic Affairs.

A flagship project for circular innovation

Under the theme “Shaping a Circular World Together”, the German Pavilion combined architecture, technology and emotion into an immersive experience. Visitors were able to explore how circular economy approaches, urban agriculture, hydrogen technologies and sustainable design can pave the way towards a sustainable future.

“Our aim was to present Germany as a land of innovation and as a driving force for a circular future,” explained Commissioner General Patrick Specht of Germany’s Federal Ministry for Economic Affairs and Energy. “That we were able to inspire more than three million visitors with our pavilion, and were additionally honoured with the Sustainability Award as well as the Silver Award for Theme Development, is a tremendous achievement. It shows how strongly our concept resonated with people.”

Both the concept and its implementation captivated audiences: in visitor surveys, more than 90 per cent of guests said their expectations had been exceeded. Many described the German contribution as one of the best at the Expo. Particularly popular was the pavilion mascot Circular, which Expo visitors voted as the most beloved mascot of the entire Expo.

Great recognition for the German Pavilion

Shortly before the Expo concluded, the German Pavilion team welcomed its three-millionth visitor. At the same time, the Bureau International des Expositions (BIE) also honoured the German Pavilion with two awards: the Silver Award for Theme Development, which recognises pavilions that convey the Expo’s guiding theme in a particularly convincing, creative and coherent way, and the Sustainability Award, presented to the German Pavilion for its exemplary integration of sustainability both conceptually and in practice. This distinction places the project among Germany’s most successful Expo presentations to date.

“This achievement demonstrates what can be accomplished when creativity, engineering excellence and project management work hand in hand,” said Böse. “Expo 2025 showcased Germany as an open, innovative and sustainable partner within the global community – and we as Koelnmesse are proud to have played our part.”

An international collaborative effort

Commissioned by the BMWE, Koelnmesse once again delivered the German Pavilion – as it had done for several previous World Expos, most recently for Dubai 2020, Shanghai 2010 and Aichi 2005.The concept, planning and realisation this year were managed by the German Pavilion Expo 2025 Osaka Consortium, consisting of facts and fiction (concept and media design) and GL events Live (construction and implementation), with support from their Japanese subsidiary. Architectural design was provided by LAVA Architects (Berlin). The Culture Connect programme was curated by VOSS+FISCHER and Mike P. Heisel, while catering and retail operations were managed by 78degrees.

Press images of Expo 2025 in Osaka and the German Pavilion are available in our image database: Expo 2025 Photos | Koelnmesse

Video impressions of Expo 2025 in Osaka and the German Pavilion are available on our YouTube channel: Video Expo 2025 | Koelnmesse

Hashtag: #Expo2025Osaka #Koelnmesse

The issuer is solely responsible for the content of this announcement.

About Koelnmesse:

Koelnmesse employs around 1,200 people. As a city trade fair in the heart of Europe, it occupies the third largest trade fair grounds in Germany and, with almost 400,000 m² of hall and outdoor space, is among the top ten largest trade fair grounds in the world. Each year, Koelnmesse organises and manages around 80 trade fairs, guest events and corporate events in Cologne and in the most important markets all over the world. Its portfolio reaches over 49,000 exhibiting companies from 129 countries and around 2,5 million visitors from more than 220 nations. Until 2040, Koelnmesse is investing more than 1 billion euro in the development of the trade fair grounds with the most extensive investment program in its history, to allow it to cover all event formats in the future. Koelnmesse has celebrated its 100th anniversary in 2024 – 100 years in which Koelnmesse has brought people and markets together worldwide.

Waters Launches Charge Detection Mass Spectrometry Technology to Accelerate the Development of Next-Generation Biotherapeutics

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Headlines:

  • Xevo™ CDMS facilitates direct, accurate mass detection for the largest, most heterogeneous biomolecules.1
  • Enables accurate analysis of protein complexes, nucleic acids, and gene delivery vehicles, including distinguishing between empty, partial, full, and overfull viral vector capsids in less than 10 minutes per sample.2
  • Decreases sample volumes by 100 times vs. current methods for assessing cells and nucleic acids.3

MILFORD, Mass., Oct. 13, 2025 /PRNewswire/ — Waters Corporation (NYSE: WAT) today unveiled the Waters Xevo Charge Detection Mass Spectrometer (CDMS), delivering unmatched measurement and characterization for the broadest range of mega-mass biomolecules central to next-generation therapeutics and structural biology. With the rapid growth of cell and gene therapies, mRNA, and complex protein therapeutics, scientists face significant challenges in analyzing increasingly large and heterogeneous drug modalities – yet existing tools are limited in resolution, sensitivity, and compliance-readiness. The Xevo CDMS System addresses these gaps with direct, individual-particle mass measurement for molecules up to 150+ MDa, enabling previously unattainable analysis of protein complexes, nucleic acids, lipid nanoparticles, viral vectors, and more.

“Waters continues to make strategic investments in large molecules, recognizing that advanced tools for bioanalytical characterization play a critical role in driving therapeutic breakthroughs. Today, we are proud to introduce the first-of-its-kind Xevo Charge Detection Mass Spectrometer, enabling the precise analysis of previously unmeasurable molecules,” said Udit Batra, Ph.D., President and Chief Executive Officer, Waters Corporation. “We believe the Xevo CDMS will accelerate the global development of genetic medicines and other advanced modalities by providing a greater understanding of the characteristics of large molecules earlier in development, which is crucial for making life-changing therapies more accessible to patients.”

The Waters Xevo CDMS provides confident analysis of new modalities, like empty, partial, and full viral vector capsids, using up to 100-fold less sample volume than that required by current techniques, and delivering results in less than ten minutes, even at concentrations as low as 1010 vp/mL. This new capability paves the way for real-time characterization of gene therapies during process development – ultimately improving the safety and efficacy of advanced therapies. Additionally, CDMS absolves the need for deconvolution or digestion approaches to achieve simple and accurate analysis of complex molecules. This transformational mass spectrometry advancement supports a wide range of applications – from discovery and research, through process development, to regulatory approval and manufacturing.

“Our mission is to accelerate the development of gene therapies for genetically mediated cardiovascular diseases and Alzheimer’s, where there is a significant unmet need in treatment options,” said Timothy Fenn, Ph.D., Vice President, Analytical Development and Quality Control, Lexeo Therapeutics. “With CDMS, we’re asking questions we didn’t know we could ask. It’s a game-changer for our analytical workflows, enabling us to generate accurate, reproducible results in minutes.”

At the heart of the Xevo CDMS is the Electrostatic Linear Ion Trap (ELIT), which provides direct measurement of individual ions through simultaneous measurement of their mass-to-charge ratio and mass. The novel technology was developed by Indiana University and Megadalton Solutions, founded by Distinguished Professors Martin Jarrold and David Clemmer at Indiana University. Waters acquired the technology assets and intellectual property rights of Indiana University in 2022 to accelerate its path to commercialization.

The Waters Xevo CDMS System is powered by the GxP-ready waters_connect™ Software and is available to order now.

ABOUT: Waters Corporation (NYSE:WAT) is a global leader in analytical instruments, separations technologies, and software, serving the life, materials, food, and environmental sciences for over 65 years. Our Company helps ensure the efficacy of medicines, the safety of food and the purity of water, and the quality and sustainability of products used every day. In over 100 countries, our 7,600+ passionate employees collaborate with customers in laboratories, manufacturing sites, and hospitals to accelerate the benefits of pioneering science.

Waters, Xevo, and waters_connect are trademarks of Waters Technologies Corporation.

Additional Resources:

Contact:

Molly Gluck
Head of External Communications
Waters Corporation
molly_gluck@waters.com
Mobile: +1.617.833.8166

References:

1 Demonstrated mass analysis on-instrument of various molecular species from <100 kDa to Chikungunya Virus complexes of >150 MDa. 

2 Time taken to acquire a statistically representative number of ions to enable characterization of AAV features.

3 Indicative of amount of sample required for sample preparation. Actual sample consumed during analysis is <5 µL. 

The Waters Xevo CDMS provides confident analysis of new modalities, like empty, partial, and full viral vector capsids, using up to 100-fold less sample volume than that required by current techniques, and delivering results in less than ten minutes.
The Waters Xevo CDMS provides confident analysis of new modalities, like empty, partial, and full viral vector capsids, using up to 100-fold less sample volume than that required by current techniques, and delivering results in less than ten minutes.

 

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