Study will evaluate AtaCor’s investigational Atala™ lead in conjunction with Abbott’s investigational EV-ICD pulse generator Study will evaluate a novel parasternal extravascular ICD approach for the treatment of life-threatening ventricular tachyarrhythmias SAN CLEMENTE, Calif., July 7,…
Author: Ken Dropiewski
Xeltis makes first commercial implant of aXess™, its vascular access device for hemodialysis
Marks start of European commercial rollout of aXess™, bringing it into routine clinical practiceBuilds on CE mark approval in record time, underpinned by positive EU pivotal trial dataIntroduces a first-of-its-kind living vascular access solution for patients requiring hemodialysis EINDHOVEN, The Netherlands, July 07, 2026 (GLOBE NEWSWIRE) — Xeltis, a leading developer of transformative implants that enable the natural creation of living and long-lasting vessels, announced today the official start of the European commercialization of aXess™, marked by the successful treatment of the first commercial patient by Dr Dominik Liebetrau at Artemed Klinikum Munich South, Germany. aXess™ represents a new category of vascular access. Implanted in a single procedure and based on Nobel Prize-winning supramolecular science, the medical device initially serves as a scaffold ready for cannulation before gradually transforming into each patient’s own living vessel, for long-term, reliable vascular access. The commercial launch follows positive 12-month European pivotal data demonstrating secondary patency comparable to matured arteriovenous fistulas (AVFs), alongside lower reintervention rates and high infection resistance compared with historical arteriovenous graft (AVG) benchmarks. It marks the beginning of Xeltis’ broader European rollout of aXess™, providing more physicians and patients with a differentiated vascular access solution that has the potential to transform the hemodialysis treatment landscape. Dr. Dominik Liebetrau, Head of Vascular Surgery at Artemed Klinikum Munich South, Germany, said: “aXess™ integrated seamlessly into our existing surgical workflow, making adoption straightforward for our team. It offers a fundamentally new approach to vascular access – providing an implant that is designed to transform into the patient’s own living vessel. This provides physicians with a valuable new option for patients requiring long-term hemodialysis access and has the potential to improve treatment outcomes and quality of life.” Eliane Schutte, Chief Executive Officer, Xeltis, added: “The first commercial implantation of aXess™ marks the transition from clinical development into routine patient care. It is an important milestone for Xeltis and the beginning of our European commercial launch, bringing a new treatment option to patients and physicians, while building the foundation for broader adoption across Europe and, ultimately, the U.S.” Elmar Horn, Vice President of Commercial, Xeltis, said: “Our first commercial implant is a significant milestone for Xeltis and reflects the commitment of our team and our physician partners. Our focus now is on supporting participating centers as they adopt aXess™, delivering a positive experience for patients and physicians, and responsibly expanding patient access across Germany and Europe.” Peter A. Schneider, Member of the Medical Advisory Board, Xeltis commented: “This is the first time we have access to a non-autologous conduit designed to become the patient’s own vessel over time through vascular cell in-growth and tissue regeneration, ultimately behaving more like an autologous vessel. This approach has the potential to address a significant unmet need in vascular access by combining fast availability for cannulation with the long-term benefits of a living vessel.” Alongside European commercialization, Xeltis continues enrollment in its US pivotal trial of aXess™, now exceeding 50% enrollment. The study builds on the positive European pivotal data and supports the Company’s broader global commercialization strategy. Contacts XeltisEliane Schutte, CEOAlexander Goemans, CFOinfo@xeltis.com Optimum Strategic CommunicationsNick Bastin, Eleanor Cooper, Aoife Minihan +44 (0) 208 078 4357xeltis@optimumcomms.com About XeltisXeltis is a medtech company developing transformative implants that enable the natural creation of living and long-lasting vessels. Xeltis seeks to address the limitations of currently available options for the millions of people requiring hemodialysis access grafts or cardiovascular replacements every year. The Company’s proprietary Restorex® platform utilizes an advanced polymer implant which transforms to the patient’s own tissue before gradually being absorbed and leaving new, living and long-lasting vessels in place. Xeltis’ most advanced product currently under commercial launch is aXess™, an implantable blood vessel for hemodialysis vascular access. Xeltis’ groundbreaking technology has high potential to be applied to other major vascular and cardiovascular diseases. Xeltis is based in The Netherlands and the USA. Its investors include DaVita Venture Group, EQT Life Sciences, Kurma Partners, VI Partners, Ysios Capital, Grand Pharma Group, the European Innovation Council and Invest-NL, in addition to other public and private investors. Visit the Xeltis website for more details: https://xeltis.com/
Catheter Precision, Inc. Announces Issuance of Two Key Patents
New Intellectual Property Covers VIVO Technology and Cardionomix Heart Failure Technology New Intellectual Property Covers VIVO Technology and Cardionomix Heart Failure Technology
GuideAI Health Appoints Renowned Interventional Radiologist Dr. James Benenati to Advisory Board Following FDA 510(k) Clearance of VAOT
Leading Vascular Specialist and Penumbra Chief Medical Officer Joins GuideAI to Help Advance Its Recently FDA-Cleared VAOT Triage SoftwareBOSTON, July 06, 2026 (GLOBE NEWSWIRE) — GuideAI Health Corp. (Cboe CA: GDAI) (“GuideAI” or the “Company”) recently received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for VascularAssist Occlusion Triage (VAOT) (please see news release dated June 22nd, 2026), the Company’s artificial intelligence software designed to support the prioritization and triage of vascular occlusion in the lower extremities. Building on this milestone, the Company is pleased to announce the appointment of James F. Benenati, MD, FSIR, a board-certified interventional radiologist and recognized leader in vascular medicine, to its Advisory Board. Dr. Benenati brings more than three decades of clinical, research, and industry leadership in vascular care to support GuideAI’s mission of detecting vascular disease earlier and improving treatment precision through artificial intelligence. VAOT is a Class II, AI-based Software as a Medical Device (SaMD) operating as a Computer-Aided Triage and Notification device (CADt). The software aims to assist radiologists in identifying and characterizing peripheral arterial disease (PAD), a leading contributor to both acute and chronic limb ischemia, by flagging suspected vascular occlusion for prioritized review within existing imaging workflows. By surfacing high-priority cases earlier, VAOT is designed to help clinical teams reduce time to diagnosis and intervention for patients at risk of limb-threatening disease. Dr. Benenati currently serves as Chief Medical Officer of Penumbra, Inc., where he also oversees the company’s clinical research efforts. Prior to that, he practiced interventional radiology at the Miami Cardiac & Vascular Institute at Baptist Hospital for 31 years, including roles as medical director of the noninvasive vascular laboratory and fellowship program director. He is a clinical professor of radiology at the Florida International University Herbert Wertheim College of Medicine and a collaborative professor of radiology at the University of South Florida Morsani College of Medicine. A past President of the Society of Interventional Radiology (SIR), Dr. Benenati has received the SIR Gold Medal and the Charles T. Dotter Award, and has authored more than 150 scientific publications and book chapters. “Vascular disease remains one of the most underdiagnosed and costly health challenges we face, and far too many cases are caught only after serious harm has been done,” said Dr. Benenati. “GuideAI is tackling this problem at its root by bringing AI-powered early detection into routine imaging workflows. I’m excited to support a team working to give clinicians the tools to identify disease sooner and guide patients toward the right treatment.” Raj Shah, MD, MBA, Chief Executive Officer of GuideAI Health, commented, “We are honoured to welcome Dr. Benenati to our Advisory Board. As one of the most respected voices in interventional radiology and vascular care, his clinical expertise, research leadership, and deep understanding of the treatment landscape will be invaluable as we advance our platform.” About GuideAI Health Corp. GuideAI Health Corp. is a healthcare technology company using artificial intelligence to enable the early detection of vascular disease and support more precise treatment decisions. Its platform analyzes routine CT scans to identify peripheral vascular disease. By surfacing disease earlier, GuideAI aims to improve patient outcomes while helping hospitals and radiology groups deliver more comprehensive vascular care. For more information, please visit www.guideaihealth.com. On Behalf of the Board of Directors: Raj Shah CEO Contact: Phone: (416) 309-3583Email: info@guideaihealth.com Cautionary Note Regarding Forward-Looking Statements This news release contains certain “forward-looking statements” and “forward-looking information” within the meaning of applicable Canadian securities laws. Forward-looking statements include, but are not limited to, the intended design and use of VAOT and the Company’s vision. These statements are based on assumptions and expectations that management considers reasonable as of the date of this release. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause actual results, performance, or achievements to differ materially from those expressed or implied. Such factors include, among others, the risks described in the Company’s public disclosure documents available under its profile on SEDAR+ at www.sedarplus.ca. Readers are cautioned not to place undue reliance on forward-looking statements. The Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law. Cboe Canada has not reviewed, approved, or disapproved the contents of this news release, and does not accept responsibility for the adequacy or accuracy of this release.
3-Year DETOUR2 Results Demonstrate Sustained Symptom Relief and Limb Preservation in Complex SFA Disease
SANTA ROSA, Calif.–(BUSINESS WIRE)–Endologix LLC, a privately held, global medical device company focused on advancing innovative therapies for the interventional treatment of vascular disease, today announced publication of 36-month results from the DETOUR2 clinical trial evaluating Percutaneous Transmural Arterial Bypass (PTAB) using the DETOUR™ System in the Journal of the Society for Cardiovascular Angiography and Interventions (JSCAI).The DETOUR2 Trial is a prospective, single-arm, intern
Acoramidis Associated with First-Ever Early and Sustained Direct Kidney-Protective Effects in ATTR-CM
– Acoramidis initiation was associated with rapid kidney-protective activity as exhibited in a hemodynamically mediated, reversible eGFR dip and a placebo-corrected 15.5% reduction in UACR by Day 28 (P
Xeltis exceeds 50% enrollment in US Pivotal trial for aXess™, its vascular access device for hemodialysis
Xeltis announces that it has exceeded 50% enrollment in its US pivotal trial for aXess™
CorVista Health Announces New AMA Category III CPT® Code for Augmentative AI Analysis of Cardiopulmonary Disease
BETHESDA, Md.–(BUSINESS WIRE)–CorVista Health, has announced that the American Medical Association (AMA) has granted a new Category III Current Procedural Terminology (CPT®) code for novel augmentative AI algorithmic analysis of potential coronary artery disease (CAD), pulmonary hypertension (PH), and elevated pulmonary capillary wedge pressure (PCWP). The new code encompasses the FDA-cleared CorVista® System for CAD and PH, as well as the anticipated PCWP Add-On algorithm which is currently
JenaValve Recaps Key Highlights Including Late-Breaking Clinical Data from New York Valves 2026
New Evidence Further Defines Distinct Clinical Considerations for Transcatheter Aortic Valve Replacement (TAVR) in Aortic Regurgitation (AR) and Advances Understanding of the Trilogy® System in Patients with Left Ventricular Assist Devices (LVADs)
Idorsia appoints Roland Wandeler as Chief Executive Officer
Ad hoc announcement pursuant to Art. 53 LR Idorsia appoints Roland Wandeler as CEO – effective October 1, 2026 – an experienced biopharmaceutical executive combining scientific expertise with business acumen to translate innovation into performance and lead Idorsia’s next phase of growthAllschwil, Switzerland – July 1, 2026Idorsia Ltd (SIX: IDIA) today announced the appointment of Roland Wandeler, PhD, as Chief Executive Officer (CEO), effective October 1, 2026. The appointment comes at a pivotal stage for Idorsia, as the company continues to execute its strategy to accelerate growth and unlock the full value of its innovative portfolio. Roland Wandeler will succeed Jean-Paul Clozel, MD, who has been serving as ad-interim CEO since March 2026 and will continue in his role as Chairman of the Board of Directors. Jean-Paul Clozel will remain CEO until October 1, 2026, ensuring full continuity in the execution of Idorsia’s strategic priorities. A leader with broad global experience across pharma and biotechRoland Wandeler, PhD, is a global biopharmaceutical executive with more than 25 years of leadership experience across the United States, Europe, and international markets. He currently serves as President, Biopharma at Grifols, where he leads a multi-billion-dollar global business. Previously, he held senior leadership roles at Amgen, including leading a major US business unit, and served as Chief Operating Officer of MorphoSys. He holds a PhD in technical sciences from ETH Zurich. Gabriel Baertschi, Chair of Idorsia’s Nominating, Governance & Compensation Committee, commented:“Following a comprehensive and rigorous global search, we are very pleased to appoint Roland Wandeler as CEO of Idorsia. He brings extensive experience across both Europe and the United States, spanning large pharmaceutical organizations and more entrepreneurial biotech environments. His scientific background, combined with a strong track record in building and leading teams and delivering commercial success, positions him strongly to take the reins. Roland understands both the dynamics of large markets and the realities of local execution, making him ideally suited to lead Idorsia through its next phase of growth.” Selecting the right leaderThe Board placed particular emphasis on identifying a leader with a long-term focus, a strong alignment with the company’s vision, and who can nurture a culture of innovation, ambition, and a pragmatic, hands-on approach. Jean-Paul Clozel, MD, Chairman of the Board and ad-interim CEO, commented:“Roland and the Board are fully aligned on Idorsia’s vision to create long-term value through innovative medicines that address significant medical needs. Our priority is to focus the organization on the activities that drive growth and maximize the impact of our portfolio. Idorsia has a unique culture rooted in science, combined with ambition and entrepreneurial spirit, and I am confident that Roland will build on this foundation and successfully advance the company.” A compelling portfolio and strong momentumRoland Wandeler, PhD, commented:“I am honored to join Idorsia and to work alongside a team that has built such a remarkable culture of scientific innovation and commitment to patients. What attracted me most is the combination of world-class science, meaningful therapies, and talented people united by a clear purpose: improving the lives of patients.” “I have been particularly impressed by the global potential of QUVIVIQ, a best-in-class therapy in insomnia, that is already helping patients around the world today, with further opportunities following the recent positive pediatric data. At the same time, innovative treatments such as TRYVIO/JERAYGO, targeting a novel pathway in hypertension; lucerastat for Fabry disease; and a compound with the potential to remyelinate in multiple sclerosis, underscore the strength of Idorsia’s late-stage and emerging pipeline and its ability to redefine standards of care.” “This combination of outstanding science and a company that has successfully navigated a financial turnaround creates a compelling opportunity. I am excited to work with the team to accelerate growth, and deliver lasting impact for patients, while creating long-term value for all our stakeholders.” Broadening commercial and partnering expertise within the executive leadership team Benjamin Limal, President Europe & International Markets, will join the Idorsia Executive Committee following strong performance across the region, where the launch and expansion of QUVIVIQ have driven accelerating uptake across key markets. Dominique Le Terrier, General Manager of France & Benelux, will assume the newly created role of Head of Global Commercial Strategy & New Product Planning and also join the Executive Committee, where he will lead global commercialization strategies for pipeline and launch assets from Phase 2 onwards, supporting future launches and portfolio value creation. Idorsia has also appointed Begoña Carreño-Gómez as Chief Business Development Officer and member of the Idorsia Executive Committee, effective November 1, 2026. She brings extensive experience in business development and licensing across both large pharmaceutical organizations and entrepreneurial biotech environments. With a strong scientific background and a proven track record in structuring partnerships and complex transactions, she will play a key role in maximizing the value of Idorsia’s portfolio by advancing strategic partnerships across assets at all stages of development, from research and platform technologies to clinical-stage and commercial products. Notes to the editor About Roland WandelerRoland Wandeler, PhD, is a global biopharmaceutical executive with more than 25 years of leadership experience across the United States, Europe, and international markets. He has a proven track record of driving commercial performance, leading organizational transformation, and delivering sustainable growth in complex and evolving healthcare environments. He currently serves as President, Biopharma at Grifols, where he leads the company’s core division, representing the majority of group revenues and overseeing a global organization with business in over 100 markets. In this role, he has strengthened financial discipline, accelerated profitable growth, and contributed to shaping enterprise strategy while engaging actively with equity and credit investors. Prior to joining Grifols, Roland Wandeler held senior leadership roles at Amgen, including Corporate Vice President and General Manager of one of the company’s largest US business units. There, he led a successful commercial turnaround, drove strong revenue and profitability growth, and implemented pricing and market access strategies to expand patient access in the United States. He also led Amgen’s operations in Germany and Iberia as General Manager, where he restored growth and improved organizational performance. He previously served as Chief Operating Officer of MorphoSys, where he played an important role in transforming the company from a research-focused organization into an integrated, US-oriented biotech with global commercial capabilities. Earlier in his career, Roland Wandeler was a consultant at The Boston Consulting Group, focusing on healthcare strategy and transformation for leading pharmaceutical and biotechnology companies in Europe and the United States. Roland Wandeler holds a PhD in technical sciences (Dr. sc. techn.) from ETH Zurich, where he graduated with distinction and received the ETH Medal for his doctoral work. He also holds a Master’s degree in Chemical Engineering (Dipl. Chem.-Ing ETH) from ETH Zurich. He is a Swiss national with international experience and has lived and worked extensively in different parts of both Europe and the United States. He is fluent in English and German and proficient in Spanish. About Begoña Carreño-GómezBegoña Carreño-Gómez, PhD, is a biopharmaceutical business development executive with more than 20 years of experience spanning research, strategy, and deal-making across global pharmaceutical and biotechnology companies. She most recently served as Chief Business Development Officer at Aspeya, where she built and led the company’s business development and licensing function. In this role, she executed more than 15 transactions across licensing, co-development, divestments, and strategic collaborations, creating significant value from a diversified portfolio of assets. Prior to Aspeya, Begoña was Global Business Development & Licensing Head (BD&L) in the Ophthalmology franchise at Novartis Pharma, AG, based in Basel. She has led BD&L efforts at Novartis across five different therapeutic franchises (respiratory, cardiovascular, metabolism, arthritis, bone and musculoskeletal diseases), as well as a proven track record in licensing deals and M&A. Before joining Novartis, she was the Head of External Pharmaceutical projects at Almirall (Barcelona, Spain). Dr. Carreño holds a PhD in Drug Delivery from the London School of Pharmacy, a 3-year Postdoctoral Research fellow at the Centre for Polymer Therapeutics (London School of Pharmacy, UK) and a BSc in Biochemistry from Keele University (UK). About IdorsiaThe purpose of Idorsia is to discover, develop and commercialize innovative medicines to help more patients. To achieve this, we will develop Idorsia into a leading biopharmaceutical company, with a strong scientific core. Headquartered near Basel, Switzerland – a European biotech hub – Idorsia has a highly experienced team of dedicated professionals, covering all disciplines from bench to bedside; QUVIVIQ™ (daridorexant), a different kind of insomnia treatment with the potential to revolutionize this mounting public health concern; strong partners to maximize the value of our portfolio; a promising in-house development pipeline; and a specialized drug discovery engine focused on small-molecule drugs that can change the treatment paradigm for many patients. Idorsia is listed on the SIX Swiss Exchange (ticker symbol: IDIA). For further information, please contact:Investor & Media RelationsIdorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, CH-4123 Allschwil+41 58 844 10 10investor.relations@idorsia.com – media.relations@idorsia.com – www.idorsia.com The above information contains certain “forward-looking statements”, relating to the company’s business, which can be identified by the use of forward-looking terminology such as “intend”, “estimates”, “believes”, “expects”, “may”, “are expected to”, “will”, “will continue”, “should”, “would be”, “seeks”, “pending” or “anticipates” or similar expressions, or by discussions of strategy, plans or intentions. Such statements include descriptions of the company’s investment and research and development programs, business development activities and anticipated expenditures in connection therewith, descriptions of new products expected to be introduced by the company and anticipated customer demand for such products and products in the company’s existing portfolio. Such statements reflect the current views of the company with respect to future events and are subject to certain risks, uncertainties and assumptions. Many factors could cause the actual results, performance or achievements of the company to be materially different from any future results, performances or achievements that may be expressed or implied by such forward-looking statements. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected. Idorsia has transferred its rights for aprocitentan, cenerimod and selatogrel to Idorsia Investments SARL to allow the repayment of notes issued in connection with the repurchase offer completed in August 2025. More details on the transfer can be found in the press release issued on May 21, 2025, and on the exchange offer in the press release issued on August 27, 2025.
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