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Primary Biliary Cirrhosis Clinical Trial Pipeline Insights Featuring 22+ Companies | DelveInsight

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New York, USA, Jan. 23, 2023 (GLOBE NEWSWIRE) — Primary Biliary Cirrhosis Clinical Trial Pipeline Insights Featuring 22+ Companies | DelveInsight

Primary biliary cholangitis, previously called primary biliary cirrhosis, is a chronic disease in which the bile ducts in the liver are slowly destroyed. Rising healthcare expenditure is one such factor that has influenced the growth rate of PBC. An increase in the number of research and development activities has also led Pharmaceutical companies to develop novel therapies for the treatment of PBC.

DelveInsight’s Primary Biliary Cirrhosis Pipeline Insight 2023 report provides comprehensive global coverage of available, marketed, and pipeline primary biliary cirrhosis therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the primary biliary cirrhosis pipeline domain.

Key Takeaways from the Primary Biliary Cirrhosis Pipeline Report

  • DelveInsight’s primary biliary cirrhosis pipeline report depicts a robust space with 22+ active players working to develop 24+ pipeline therapies for primary biliary cirrhosis treatment. 
  • Key primary biliary cirrhosis companies such as Genfit, CymaBay Therapeutics, Calliditas Therapeutics, Zydus-Cadila, Cour Pharmaceutical, Mirum Pharmaceuticals, HighTide Biopharma, PRISM Pharma Co, Albireo Pharma, Pliant Therapeutics, GentiBio, Gannex Pharma, Selecta Biosciences, Intercept Pharmaceuticals, Umecrine Cognition, Suzhou Zelgen Biopharmaceuticals, Merck Sharp & Dohme LLC, Kowa Pharmaceuticals, and others are evaluating new primary biliary cirrhosis drugs to improve the treatment landscape.
  • Promising primary biliary cirrhosis pipeline therapies such as Elafibranor, Seladelpar, Setanaxib, Bilypsa, CNP-104, ASC42, Volixibat, Bezafibrate, HTD1801, OP-724, A3907, PDC-E2, HM15211, Pemafibrate, Emtricitabine/Tenofovir Disoproxil/Raltegravir, Research program, Pemafibrate,  and others are under different phases of primary biliary cirrhosis clinical trials.
  • In November 2022, CymaBay Therapeutics, Inc. announced encouraging seladelpar data in patients with primary biliary cholangitis (PBC) that were presented at The Liver Meeting of the American Association for the Study of Liver Diseases (AASLD) in Washington, DC (November 4th – 8th). A clinical poster presentation titled “Seladelpar Improved the Lipid Profile of Patients with Primary Biliary Cholangitis (PBC): Results from Phase 2 and 3 Clinical Studies” reported positive results and showed that treatment with seladelpar resulted in significant improvements in total cholesterol (TC), LDL-C, HDL-C, and triglycerides (TG). A second poster presenting clinical data titled “Seladelpar, a PPAR-delta Agonist, Improves Inflammatory Lipid Mediators in the Serum Metabolome in Patients with Primary Biliary Cholangitis (PBC)” revealed that seladelpar treatment in patients with PBC resulted in broad changes in serum metabolomics.
  • In August 2022, Gannex Pharma Co., Ltd., owned by Ascletis Pharma Inc., announced that it had finished its first dosing in the US drug-drug interaction (DDI) study of Farnesoid X Receptor agonist ASC42 for treatment of PBC. The DDI study and ongoing phase II clinical trial in PBC patients in China will provide more evidence to support upcoming phase III trials in the US, China, and the European Union.
  • GENFIT is currently evaluating its proprietary drug candidate, elafibranor, a dual agonist of PPARα and PPARδ in PBC. Enrollment is ongoing for the Phase III clinical trial ELATIVE (NCT04526665), which aims to confirm elafibranor 80mg efficacy, based upon changes in biochemical parameters and its potential to improve pruritus, and safety in patients with PBC. Elafibranor was granted Breakthrough Therapy designation by the FDA in April 2019 for the treatment of PBC in adults with inadequate response to UDCA, as well as Orphan Drug Designation by the FDA and the EMA (European Medicines Agency) in July 2019. In November 2022, Genfir announced that Phase III data for elafibranor in primary biliary cholangitis (PBC) is  expected in 2Q23.
  • CNP-104 is being developed utilizing Cour’s nanoparticle platform (CNP), a novel, proprietary system which combines disease-specific pathogenic antigens with state-of-the-art pharmaceutical nanoparticles that mimic normal removal of dead or dying cells from the body. Cour’s platform has shown proof of technology in clinical and preclinical settings. COUR is currently conducting a clinical study with top-line data expected to read out in 2023. In January 2022, the US Food and Drug Administration (FDA) granted Fast Track designation to CNP-104 for the treatment of primary biliary cholangitis (PBC).

Request a sample and discover the recent advances in primary biliary cirrhosis treatment drugs @ Primary Biliary Cirrhosis Pipeline Report

The primary biliary cirrhosis pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage primary biliary cirrhosis drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the primary biliary cirrhosis clinical trial landscape.

Primary Biliary Cirrhosis Overview

Primary biliary cirrhosis (PBC) is an autoimmune-related chronic and slowly progressive cholestatic liver disease characterized by intrahepatic bile duct injury that can lead to liver failure. At the time of primary biliary cirrhosis diagnosis, most patients are in their fifth to seventh decades of life, and 90% are female.

PBC does not always cause symptoms, but some people may experience bone and joint aches, fatigue (extreme tiredness), itchy skin, dry eyes and mouth, and pain or discomfort in their upper right tummy. Most patients are asymptomatic at the time of diagnosis; however, some patients present with fatigue and pruritus.

A combination of clinical features, an abnormal liver biochemical pattern in a cholestatic picture that persists for more than six months, and the presence of detectable antimitochondrial antibodies (AMA) in serum are used to make the primary biliary cirrhosis diagnosis.

Find out more about primary biliary cirrhosis treatment drugs @ Drugs for Primary Biliary Cirrhosis Treatment

A snapshot of the Primary Biliary Cirrhosis Pipeline Drugs mentioned in the report:

Drugs Company Phase  MoA RoA
Elafibranor   Genfit Phase III Antioxidants; Peroxisome proliferator-activated receptor alpha agonists Oral
Seladelpar   CymaBay Therapeutics Phase III C-reactive protein inhibitors; Peroxisome proliferator-activated receptor delta agonists Oral
Bezafibrate/obeticholic acid Intercept Pharmaceuticals Phase II Farnesoid X-activated receptor agonists; Peroxisome proliferator-activated receptor alpha agonists; Peroxisome proliferator-activated receptor delta agonists; Peroxisome proliferator-activated receptor gamma agonists Oral
CNP-104 Cour Pharmaceutical  Phase II Immunomodulators Intravenous
ASC42 Gannex Pharma Phase II Farnesoid X-activated receptor agonists; Hepatitis B surface antigen expression inhibitors; RNA inhibitors Oral
OP-724 Ohara Pharmaceutical Phase I Beta catenin inhibitors; CREB-binding protein inhibitors; Wnt signalling pathway inhibitors Intravenous
PDC-E2 Selecta Biosciences Preclinical NA NA

Learn more about the emerging primary biliary cirrhosis pipeline therapies @ Primary Biliary Cirrhosis Clinical Trials

Primary Biliary Cirrhosis Therapeutics Assessment

The primary biliary cirrhosis pipeline report proffers an integral view of the primary biliary cirrhosis emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration.

Scope of the Primary Biliary Cirrhosis Pipeline Report 

  • Coverage: Global 
  • Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination
  • Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III
  • Therapeutics Assessment By Route of Administration: Intra-articular, Intraocular, Intrathecal, Intravenous, Ophthalmic, Oral, Parenteral, Subcutaneous, Topical, Transdermal
  • Therapeutics Assessment By Molecule Type: Oligonucleotide, Peptide, Small molecule
  • Therapeutics Assessment By Mechanism of Action: Antioxidants; C-reactive protein inhibitors; Peroxisome proliferator-activated receptor delta agonists, Farnesoid X-activated receptor agonists; Peroxisome proliferator-activated receptor alpha agonists; Peroxisome proliferator-activated receptor gamma agonists, Immunomodulators, Farnesoid X-activated receptor agonists; Hepatitis B surface antigen expression inhibitors; RNA inhibitors, Beta catenin inhibitors; CREB-binding protein inhibitors; Wnt signalling pathway inhibitors
  • Key Primary Biliary Cirrhosis Companies: Genfit, CymaBay Therapeutics, Calliditas Therapeutics, Zydus-Cadila, Cour Pharmaceutical, Mirum Pharmaceuticals, HighTide Biopharma, PRISM Pharma Co, Albireo Pharma, Pliant Therapeutics, GentiBio, Gannex Pharma, Selecta Biosciences, Intercept Pharmaceuticals, Umecrine Cognition, Suzhou Zelgen Biopharmaceuticals, Merck Sharp & Dohme LLC, Kowa Pharmaceuticals  and others
  • Key Primary Biliary Cirrhosis Pipeline Therapies: Elafibranor, Seladelpar, Setanaxib, Bilypsa, CNP-104, ASC42, Volixibat, Bezafibrate, HTD1801, OP-724, A3907, PDC-E2, HM15211, Pemafibrate, Emtricitabine/Tenofovir Disoproxil/Raltegravir, Research program, Pemafibrate and others

Dive deep into rich insights for new drugs for primary biliary cirrhosis treatment, visit @ Primary Biliary Cirrhosis Drugs

Table of Contents

1. Primary Biliary Cirrhosis Pipeline Report Introduction
2. Primary Biliary Cirrhosis Pipeline Report Executive Summary
3. Primary Biliary Cirrhosis Pipeline: Overview
4. Analytical Perspective In-depth Commercial Assessment
5. Primary Biliary Cirrhosis Clinical Trial Therapeutics
6. Primary Biliary Cirrhosis Pipeline: Late Stage Products (Pre-registration)
7. Primary Biliary Cirrhosis Pipeline: Late Stage Products (Phase III)
7.1 Elafibranor: Genfit
8. Primary Biliary Cirrhosis Pipeline: Mid Stage Products (Phase II)
8.1 CNP-104: Cour Pharmaceutical
9. Primary Biliary Cirrhosis Pipeline: Early Stage Products (Phase I)
9.1 OP-724: Ohara Pharmaceutical
10. Primary Biliary Cirrhosis Pipeline Therapeutics Assessment
11. Inactive Products in the Primary Biliary Cirrhosis Pipeline
12. Company-University Collaborations (Licensing/Partnering) Analysis
13. Key Companies
14. Key Products in the Primary Biliary Cirrhosis Pipeline
15. Unmet Needs
16. Market Drivers and Barriers
17. Future Perspectives and Conclusion
18. Analyst Views
19. Appendix

For further information on the primary biliary cirrhosis pipeline therapeutics, reach out @ Primary Biliary Cirrhosis Treatment Drugs

Related Reports

Primary Biliary Cirrhosis Epidemiology

Primary Biliary Cirrhosis Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted primary biliary cirrhosis epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan.

Primary Biliary Cirrhosis Market

Primary Biliary Cirrhosis Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key primary biliary cirrhosis companies, including Cour Pharmaceutical Development, Ascletis, Novartis, Mirum Pharmaceuticals, Intercept Pharmaceuticals, among others.

Primary Sclerosing Cholangitis Market

Primary Sclerosing Cholangitis Market Insights, Epidemiology, and Market Forecast – 2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key primary sclerosing cholangitis companies,  including Mirum Pharmaceuticals, Chemomab Therapeutics, Cascade Pharmaceuticals, among others.

Primary Sclerosing Cholangitis Pipeline

Primary Sclerosing Cholangitis Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key primary sclerosing cholangitis companies,  including Mirum Pharmaceuticals, Chemomab Therapeutics, Cascade Pharmaceuticals, among others.

Primary Sclerosing Cholangitis Epidemiology Forecast

Primary Sclerosing Cholangitis Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted primary sclerosing cholangitis epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan.

Nonalcoholic Steatohepatitis Pipeline

Nonalcoholic Steatohepatitis Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key nonalcoholic steatohepatitis companies, including Boehringer Ingelheim, Oramed Pharmaceuticals, ENYO Pharma, Terns Pharmaceuticals, Cirius Therapeutics, among others.

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About DelveInsight

DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. 

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Artificial Intelligence

Management ‘bought the AI hype’ and expect value but research shows lack of organizational readiness is primary hurdle: IFS

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IFS commissioned research shows value creation lags AI promise without the right planning and application
LONDON, April 23, 2024 /PRNewswire/ — New research from IFS, the global cloud enterprise software company, has found that executive and board leadership have ‘bought the AI hype’ but organizations are unable to deliver operationally on expectations. The new global study of 1,700 senior decision makers, Industrial AI: the new frontier for productivity, innovation and competition, found that the promise of AI is being held back by technology, processes and skills. Half of respondents remain optimistic that with the right AI strategy, value can be realized in the next two years, and a quarter believe in the next year.

Expectations failing to meet reality
84% of executives anticipate massive organizational benefits from AI, with the top three areas AI is expected to deliver value in being high-impact: product & service innovation, improved internal & external data availability, and cost reductions & margin gains. The hype has become so high that 82% of senior decision-makers acknowledge that there is significant pressure to adopt AI quickly. However, this same group of respondents state that they are concerned that a failure to plan, implement and communicate properly means AI projects will stall in pilot stage.
Many organizations have not prioritized elements of development, nor have the infrastructure required to reap the rewards or the skills to deliver on that promise. The study found that over a third (34%) of businesses had not moved to the cloud. While this is not essential to AI adoption, it is indicative of an unprepared enterprise unlikely to be able to scale AI across their business. According to IFS, a robust Industrial AI strategy requires a potent combination of cloud, data, processes, and skills. 80% of respondents agree that the lack of a strategic approach means they have insufficient skills in-house to successfully adopt AI. This sentiment is seen elsewhere in the research with 43% of respondents rating the quality of AI resources in their business, in terms of human skills, as passable and not where it needs to be.
Christian Pedersen, Chief Product Officer, IFS, commented: “AI is poised to become the most transformational enterprise tool ever seen, but our research reveals that there are still fundamental misunderstandings about how to harness its power within an industrial setting. It is telling that AI is expected to significantly reduce costs and raise margins, but a lack of robust strategy means most businesses are under-skilled and under-prepared to achieve these ambitions. We built IFS.ai specifically with these challenges in mind. AI value simply will not be found in a single AI capability but instead by delivering AI across all products and business processes. This supports customers’ decision cycles and provides the data and AI services required to realize value faster.”
Pedersen continued: “Achieving this at scale needs a clear-eyed strategic focus, including the high-impact use cases specific to their industry, having a cloud-based infrastructure in place which has industrial AI embedded, and investing early in developing the skills needed. Adopting this approach will turn the tide of disillusionment, and deliver the benefits that boards and the C suite are demanding.”
Outlook optimistic but planning needed
The unfortunate reality of the skills gap means that in terms of AI readiness, many businesses are falling behind. IFS found that nearly half of respondents (48%) were most likely to say that they are gathering proposals and were much less likely to have a clear strategy and perceivable results (27%). A fifth of respondents are in the research phase, with uncontrolled tests taking place and a further 5% are lacking a coordinated approach and do not have anything in motion yet. Despite initial challenges, there is still optimism with respondents most likely to feel AI could make a significant difference to their business in 1-2 years (47%), and a further quarter (24%) believe it could be within a year.
In particular, respondents are most optimistic about the impact of AI in smart production and/or service delivery on effectiveness & business and operational management (22%) in the future. One fifth see the biggest impact being on innovation with new products and services (20%), growth & business model decision-making (20%), empowering people and increasing talent retention (19%), and customer experience and customer service (19%).
Action needed on data readiness
To reap these benefits, enterprises need to leverage the most strategic asset they have – their data. The right data volume and quality is critical for the success of AI applications. Respondents recognize how important real-time data is to successful AI projects, with over 4 in 5 (86%) stating this. Yet despite this recognition, less than a quarter (23%) of respondents have completed their data foundation with it supporting both data-driven business decision making and real time response to changes, suggesting that more work needs to be done to get data AI ready. Moreover, under half (43%) of respondents have majority structured data, with some unstructured.
Pedersen commented: “The lack of maturity at the data foundation layer needs to be addressed as part of an overall AI strategy, otherwise AI simply will never be the magic bullet that can turbocharge the enterprise. Clearly enterprises need support on data management and migration. While AI is seen as a shiny new tool that will revolutionize business, like all technology, it is never that simple. The power of Industrial AI is that it can touch all facets of a business from product innovation and customer experience to productivity and ESG. Its potential is massive if executives and organizations can combine vision, strategy, technology and skills. Now is the time to step back, take stock, and build a true Industrial AI plan and turn the hype into reality.”
Methodology:
Censuswide surveyed 1,709 C-level/President/SVP/Directors who work in Manufacturing, Telecommunications, A&D, Services, Construction & Engineering or Energy & resources in organizations with $50m+ annual revenue (Aged 18+) across the UK, USA, Canada, Germany, France, UAE, Norway, Japan, Australia, Sweden, Denmark and Finland between 06.03.2024 – 27.03.2024.
IFS Press Contacts:MEA& APJ: Adam GillbeCorporate CommunicationsEmail: [email protected] Phone: +44 7775 114 856
USA: Mairi MorganCorporate CommunicationsEmail: [email protected] Phone: +44 7918 607 299
This information was brought to you by Cision http://news.cision.com
https://news.cision.com/ifs/r/management–bought-the-ai-hype–and-expect-value-but-research-shows-lack-of-organizational-readiness,c3965172
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University medical centers in Germany choose Sectra’s radiology solution to streamline workflows and shorten lead times for patients

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LINKÖPING, Sweden, April 23, 2024 /PRNewswire/ — International medical imaging IT and cybersecurity company Sectra (STO: SECT B) has signed two contracts to provide the radiology module of its enterprise imaging solution with two university medical centers in Germany—Universitätsklinikum Tübingen and Universitätsmedizin Göttingen. By implementing Sectra’s radiology solution, the hospitals aim to improve and streamline radiology workflows with Sectra’s tools for enhanced reporting efficiency, in turn speeding up diagnostics.

“When choosing a vendor, we wanted one that could provide us with a stable and fast system. We also wanted one facilitating collaboration among our radiologists. That way we can streamline our radiology workflows and in turn shorten lead times for patients as well as reduce the ever increasing workload for radiologists,” says Dr. Babak Panahi, Managing Senior Physician and Head of CT and CT Intervention, Universitätsmedizin Göttingen.
Universitätsmedizin Göttingen and Universitätsklinikum Tübingen are two university medical centers located in the cities of Göttingen and Tübingen in Germany managing 300,000 and 600,000 radiology exams a year. The two separate contracts for Sectra’s radiology solution were both signed during the third quarter of Sectra’s 2023/2024 fiscal year.
“Radiologists are under a lot of pressure as they are challenged to handle more images and more complex cases with less resources. Having a solution designed to streamline radiology workflows, facilitating reading and reporting of images, is therefore paramount. I am happy and excited to support Universitätsmedizin Göttingen and Universitätsklinikum Tübingen on their journey towards efficient radiology diagnostics,” says Guido Bötticher, Managing Director, Sectra DACH.
The radiology module is part of Sectra’s enterprise imaging solution that provides a unified strategy for all imaging needs while lowering operational costs. The scalable and modular solution, with a VNA at its core, allows healthcare providers to grow from ology to ology and from enterprise to enterprise. Visit Sectra’s website to read more about Sectra and why it’s top-ranked in ‘Best in KLAS’.
About SectraSectra contributes to a healthier and safer society by assisting health systems throughout the world to enhance the efficiency of care, and authorities and defense forces in Europe to protect society’s most sensitive information. The company, founded in 1978, is headquartered in Linköping, Sweden, with direct sales in 19 countries, and distribution partners worldwide. Sales in the 2022/2023 fiscal year totaled SEK 2,351 million. The Sectra share is quoted on the Nasdaq Stockholm exchange. For more information, visit Sectra’s website.
For further information, please contact: Dr. Torbjörn Kronander, CEO and President Sectra  AB, 46 (0) 705 23 52 27Marie Ekström Trägårdh, Executive Vice President Sectra AB and President Sectra Imaging IT Solutions, 46 (0)708 23 56 10
This information was brought to you by Cision http://news.cision.com
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New CPS Protection Platform: TXOne Networks Unveils SageOne at GISec Global

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TAIPEI, April 23, 2024 /PRNewswire/ — TXOne Networks, a frontrunner in the realm of cyber-physical systems (CPS) security, is set to unveil its groundbreaking CPS security platform, SageOne, at the highly anticipated GISec Global from April 23rd to 25th, 2024. Attendees can find TXOne Networks showcasing SageOne at stand B99 in hall 5. This innovative platform consolidates all CPS security products onto a single, central management platform, promising streamlined operations and optimized threat detection capabilities.

SageOne, aptly named “Wise Man Number One,” serves as a comprehensive management console providing a holistic view of the CPS attack surface within operational technology (OT) environments. By enabling centralized control of TXOne’s three core product lines – Stellar for endpoint protection, Element for security inspection, and Edge for network defense – SageOne facilitates integrated OT security throughout the lifecycle of protected assets, ensuring robust threat detection and response mechanisms.
Key features of SageOne include:
CPS Attack Surface Management: Prioritizing operational security by offering clear visibility into the overall security posture of OT environments, SageOne identifies security focal points, illuminating asset information and security controls.Integrated Lifecycle Protection: Through centralized management, SageOne simplifies cybersecurity governance and fosters collaborative defense. It serves as an abstraction layer, facilitating contextualization and consolidation of data across multiple products, offering tailored, task-oriented consoles for executives, security personnel, and plant leaders.CPS Threat Detection & Response: SageOne aggregates security insights from various solutions to scout for potential risks, enabling early caution and response to both known and unknown threats.SageOne’s foundation rests upon advanced components, including Threat Intelligence, Behavior-Based AI Analytics Engines, Compliance Framework, Data Visualizer, and Ecosystem Integrator, ensuring comprehensive protection and seamless integration of different tools and technologies.
With its focus on analyzing unexpected behavior and unknown threats, SageOne enables the identification of suspicious events through cross-telemetry analysis within the OT-native XDR engine. This amalgamation of advanced technologies and user-friendly interface ensures the protection of critical infrastructures.
For rapid threat response, SageOne issues early warnings of suspicious behavior and orchestrates cross-telemetry analysis for CPS Threat Detection & Response. Integrated Lifecycle Protection ensures the security of devices and systems throughout their service life, contributing to great cost efficiency.
TXOne Networks reaffirms its commitment to CPS security and continuous advancement in OT security through SageOne. Visit TXOne Networks at the GISec Global from April 23rd to 25th, 2024, at stand B99 in hall 5.
For further updates and information, follow TXOne Networks on the blog, Twitter, and LinkedIn.
About TXOne Networks:
TXOne Networks provides OT security products ensuring reliability and security in industrial control systems and operational technology environments through the OT Zero Trust methodology. Collaborating with leading industrial manufacturers and critical infrastructure operators, TXOne Networks offers practical and business-friendly approaches to OT defense. Its network and endpoint-based products secure OT networks and mission-critical devices in real-time with high security depth.
Website: www.txone.com 
Photo – https://mma.prnewswire.com/media/2389611/SageOne_header_3.jpg

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