Alma Mater Studiorum - Università di Bologna

The GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis indication expansion brings the first bridging stent device with dual indication for both fenestrated and branched endovascular repair*. PUTZBRUNN, Germany, July 9, 2025 /PRNewswire/ -- W. L. Gore & Associates (Gore) announces CE Mark approval of an expanded indication for the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX Stent Graft) when used as a bridging stent with branched and fenestrated aortic endografts† in the treatment of aortic aneurysms involving the renal and mesenteric arteries. Continue Reading GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis "This is a landmark indication for a stent graft, equipping physicians with an on-label solution for more patients in complex pathologies," said Prof. Luca Bertoglio, Associate Professor, Vascular Surgery, Spedali Civili Brescia and Coordinating Investigator of the EMBRACE Registry. A total of 259 patients were enrolled in the study. High rates of patency and freedom from endoleaks, target vessel instability and reinterventions were observed with the VBX Stent Graft in both branched and fenestrated EVAR (bEVAR and fEVAR) cohorts at 1 year. "We have studied performance in both fenestrated and branched cohorts, and the results demonstrate that we can safely and effectively treat these patients with the VBX Device," Prof. Bertoglio added. This multicenter, retrospective and prospective registry was conducted to evaluate the clinical performance and safety of the VBX Stent Graft as a bridging stent. A total of 14 centers in Europe enrolled 259 patients who have had treatment with the VBX Stent Graft. These subjects will have prospective follow-up visits up to 5 years after the index procedure. "Physicians have waited some time for an approved bridging stent indication for fenestrated and branched repair. Having a CE-marked indication is very important, as it is certainly of relevance to the endovascular community and the eligible patient population," said Prof. Mauro Gargiulo, Chair of Metropolitan Unit of Vascular Surgery at IRCCS S. Orsola Hospital, University of Bologna and Principal Investigator of the EXPAND1 Registry. "I applaud Gore for recognizing the need for a CE Mark indication and for being committed to conducting such thorough and expertly run clinical studies like EXPAND and EMBRACE." In the coming weeks, hospitals will start implanting the newly indicated VBX Stent Graft in fEVAR and bEVAR procedures. The official launch is planned after summer when many European and local congresses are taking place. The VBX Stent Graft offers precise delivery and supports positive outcomes in a variety of complex applications. The device was developed utilizing the small diameter, ePTFE stent graft technology from the GORE® VIABAHN® Endoprosthesis. The VBX Stent Graft is available in a range of diameters from 5 to 11 mm and lengths of 15, 19, 29, 39, 59 and also 79 mm. It is currently the longest balloon expandable stent graft available, covering a wide variety of treatment needs. The VBX Stent Graft also offers the largest range of diameter adjustability in a single device, with a maximum post-dilated diameter of up to 16 mm with 8L or 11 mm devices.†,2-5 Additional information about the EMBRACE and EXPAND clinical studies is available at and EMBRACE and EXPAND Registries are part of Gore's dedication to research, fitness-for-use and long-term device performance in an effort to expand device indications, improve clinical practice and patient outcomes. Data will be representative of real-world, clinical use. Real-world clinical use data are integral for Gore, combined with data from long-term clinical investigations and reports from medical literature, to perform continuing assessments of device performance in addition to any long-term clinical investigations as well as reports in medical journals and congress presentations. "This is another step in our continuing efforts to offer the broadest endovascular treatment capabilities on the market. This announcement is the culmination of years of deep collaboration with physicians aimed at understanding and overcoming clinical and technical challenges in complex aortic repair," according to Jill Paine, leader of Gore's Peripheral Business. For more information about the VBX Stent Graft, visit goremedical.com/eu. Gore engineers medical devices that treat a range of cardiovascular and other health conditions. With more than 55 million medical devices implanted over the course of more than 45 years, Gore builds on its legacy of improving patient outcomes through research, education and quality initiatives. Product performance, ease of use and quality of service provide sustainable cost savings for physicians, hospitals and insurers. Gore is joined in service with clinicians and through this collaboration we are improving lives. goremedical.com/eu. About Gore W. L. Gore & Associates is a global materials science company dedicated to transforming industries and improving lives. Since 1958, Gore has solved complex technical challenges in demanding environments — from outer space to the world's highest peaks to the inner workings of the human body. With more than 13,000 Associates and a strong, team-oriented culture, Gore generates annual revenues of $5 billion. gore.com. 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- Data will be presented as an oral presentation at EHA on Thursday, June 12, 2025, and at ICML on Thursday, June 19, 2025 BOULDER, Colo., June 10, 2025 /PRNewswire/ -- Foresight Diagnostics, a leading developer of ultra-sensitive minimal residual disease (MRD) detection technologies, today announced that validation data demonstrating the prognostic performance of its CLARITY™ MRD assay in patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL) will be featured as encore oral presentations at two upcoming international conferences: the 2025 European Hematology Association (EHA) Congress (June 12–15, in Milan, Italy) and the 18th International Conference on Malignant Lymphoma (ICML) (June 17–21, in Lugano, Switzerland). This multi-center study, conducted in collaboration with Amsterdam University Medical Centers, the Hemato-Oncology Foundation for Adults in the Netherlands (HOVON), and the Netherlands Comprehensive Cancer Organization (IKNL), highlights real-world results using Foresight CLARITY™ MRD on patients who were treated with frontline chemotherapy across over 50 centers in the Netherlands and Belgium. "We're grateful to present our data at major medical meetings this spring, validating our science and the real-world utility of ultra-sensitive ctDNA-MRD technology," said David Kurtz, M.D., Ph.D., Chief Medical Officer of Foresight Diagnostics. "These presentations and the recent incorporation of ctDNA-MRD testing in B-cell lymphoma clinical guidelines give us confidence as we prepare to launch in the clinical market in 2026 and integrate Foresight CLARITY into routine clinical practice." Lead study authors Steven Wang, M.D., and Martine Chamuleau, M.D., Ph.D., Amsterdam UMC, added: "Our findings confirm that ultra-sensitive ctDNA-MRD detection provides meaningful prognostic information beyond standard imaging and clinical factors. We believe this assay can support better risk stratification than imaging alone and inform post-treatment management decisions in DLBCL." Oral presentation details for EHA: Title: Prospective validation of end of treatment ctDNA-MRD by PhasED-Seq in DLBCL patients from a national trial Presenter: Martine Chamuleau, MD, PhD (Amsterdam UMC) Session: Aggressive Non-Hodgkin lymphoma - Clinical (Observational) Time: Thursday, June 12 | 5:00 p.m. – 5:15 p.m. CEST / 11:00 a.m. – 11:15 a.m. ET Room: Brown Hall 3 Abstract number: S240 Oral presentation details for ICML: Title: Prospective validation of end of treatment ctDNA-MRD by PhasED-Seq in DLBCL patients from a national HOVON trial Presenter: Martine Chamuleau, MD, PhD (Amsterdam UMC) Session: Session 6: Liquid biopsy for response assessment Time: Thursday, June 19 | 2:15 p.m. – 2:30 p.m. CEST / 8:15 a.m. – 8:30 a.m. ET Room: Polivalente room, East Campus USI Article number: 041 In addition to the oral presentation, Foresight's technology will be highlighted in other presentations, including: Title: Prognostic Value of Circulating Tumor DNA (ctDNA) Detection by PhasED-Seq After Axicabtagene ciloleucel (Axi-cel) Therapy in Relapsed/Refractory Large B-Cell Lymphoma (LBCL) Meeting: EHA 2025 Sponsor: Kite Pharma Presenter: Jeffrey Gregg, MD (Foresight Diagnostics) Session: Poster Session I | Poster Hall Date/Time: Friday, June 13 | 6:30 p.m. – 7:30 p.m. CEST / 12:30 p.m. – 1:30 p.m. ET Abstract: #PF1002 Title: The Correlation of Mutational Profiles and Valemetostat Efficacy in Patients With R/R PTCL in the Phase 2 VALENTINE-PTCL01 Trial Meeting: ICML 2025 Sponsor: Daiichi Sankyo Presenter: Pier Luigi Zinzani, MD, PhD (University of Bologna) Session: "Focus On" Session Biology and Therapy of T-cell Lymphomas | Room B Date/Time: Saturday, June 14 | 10:05 a.m. – 10:15 a.m. CEST / 4:05 a.m. – 4:15 a.m. ET Article Number: 164 About Foresight Diagnostics Foresight Diagnostics is a privately held cancer diagnostics company and CLIA-registered laboratory. Its liquid biopsy platform, Foresight CLARITY™, is a novel assay that measures minimal residual disease (MRD) with reported detection limits in parts per million. The improved sensitivity of Foresight CLARITY™ has the potential to provide actionable information to physicians and biopharmaceutical companies to enable personalized treatment approaches for patients with solid tumor and hematologic malignancies. For more information, please visit foresight-dx.com and follow us on X, LinkedIn, and Bluesky. SOURCE Foresight Diagnostics, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

HOUSTON, March 3, 2025 — Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, today announced its abstract has been accepted for poster presentation at the Acute Leukemias XIX (ISALXIX) International Symposium being held March 16-19, 2025 in Munich, Germany. Details for the poster presentation are as follows: Abstract: P002Session: Clinical Studies in AML and ALLTitle: Liposomal Annamycin in Combination with Cytarabine for Treatment of Acute Myeloid Leukemia (AML)Presenting Author: Cristina Papayannidis, MD, PhD, Adjunct professor, Department of Medical and Surgical Sciences, University of Bologna, Bologna Italy For more information about the ISALXIX International Symposium, visit the event website. About Moleculin Biotech, Inc. Moleculin Biotech, Inc. is a Phase 3 clinical stage pharmaceutical company advancing a pipeline of therapeutic candidates addressing hard-to-treat tumors and viruses. The Company’s lead program, Annamycin, is a next-generation anthracycline designed to avoid multidrug resistance mechanisms and to eliminate the cardiotoxicity common with currently prescribed anthracyclines. Annamycin is currently in development for the treatment of relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases. The Company is initiating the MIRACLE (Moleculin R/R AML AnnAraC Clinical Evaluation) Trial (MB-108), a pivotal, adaptive design Phase 3 trial evaluating Annamycin in combination with cytarabine, together referred to as AnnAraC, for the treatment of relapsed or refractory acute myeloid leukemia. Following a successful Phase 1B/2 study (MB-106), with input from the FDA, the Company believes it has substantially de-risked the development pathway towards a potential approval for Annamycin for the treatment of AML. This study is subject to appropriate future filings with potential additional feedback from the FDA and their foreign equivalents. Additionally, the Company is developing WP1066, an Immune/Transcription Modulator capable of inhibiting p-STAT3 and other oncogenic transcription factors while also stimulating a natural immune response, targeting brain tumors, pancreatic and other cancers. Moleculin is also engaged in the development of a portfolio of antimetabolites, including WP1122 for the potential treatment of pathogenic viruses, as well as certain cancer indications. For more information about the Company, please visit www.moleculin.com and connect on X, LinkedIn and Facebook. Investor Contact:JTC Team, LLCJenene Thomas(908) 824-0775MBRX@jtcir.com View original content to download multimedia:https://www.prnewswire.com/news-releases/moleculin-abstract-accepted-for-poster-presentation-at-the-acute-leukemias-xix-isalxix-international-symposium-302389270.html SOURCE Moleculin Biotech, Inc.