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Medtronic Endurant™ stent graft system first and only to receive CE-mark for updated rupture labeling

Following recent U.S. Food and Drug Administration (FDA) labeling approval, European label milestone reinforces Medtronic leadership in advancing aortic care based on clinical evidence supporting the treatment of ruptured abdominal aortic aneurysms (rAAA). Cardiovascular Diagnostics and Services Europe, Middle East & Africa Medtronic plc, a global leader in healthcare technology, […]

Anteris Technologies Announces Results for the Second Quarter of 2026

MINNEAPOLIS and BRISBANE, Australia, Aug. 11, 2026 (GLOBE NEWSWIRE) — Anteris Technologies Global Corp. (“Anteris” or the “Company”) (NASDAQ: AVR, ASX: AVR) a global healthcare company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function, today reported financial results for the quarter ended June 30, 2026, and provided a corporate update. Q2 2026 Highlights Secured U.S. Medicare reimbursement eligibility for the global pivotal PARADIGM Trial under a Centers for Medicare & Medicaid Services (CMS) national coverage policy, enabling reimbursement for eligible procedures at U.S. sites.Initiated U.S. recruitment in the PARADIGM Trial, with the first U.S. patients enrolled and treated in May 2026.Expanded the PARADIGM Trial, with active recruitment underway in the U.S., Denmark and the Netherlands, and obtained regulatory clearance in Canada and France.Appointed Ms. Susan Knight and Mr. Stephen Denaro to the Board of Directors, broadening governance, financial and public company leadership as the Company advances the DurAVR® THV toward commercialization.Presented clinical and scientific progress at New York Valves 2026, including a symposium, innovation session feature, and pre-recorded live case presentation highlighting clinical experience with the DurAVR® THV. The symposium recording is available on the Company’s website under the News section. “Q2 marked an important period of execution for Anteris as we advanced the PARADIGM Trial across clinical, regulatory and reimbursement milestones. During the quarter, we secured U.S. Medicare reimbursement for eligible procedures, initiated U.S. recruitment in the PARADIGM Trial, expanded active recruitment across key geographies and showcased growing clinical experience with DurAVR® at New York Valves, a leading structural heart conference. These achievements, together with the continued strengthening of our Board, support our progress toward commercialization and our commitment to improving outcomes for patients with severe aortic stenosis,” said Wayne Paterson, Vice Chairman and Chief Executive Officer of Anteris. Business & Operations During the quarter, we continued to advance execution of the global pivotal PARADIGM Trial across active European sites and commenced patient enrollment in the United States. Clinical centers are progressing through key start-up milestones, including ethics and regulatory approvals, site initiation visits and investigator training, alongside patient screening and enrollment at activated sites. This includes selected Australian sites, which are progressing through initial start-up documentation, with activation and patient recruitment to follow subject to ethics committee approval at each site. In the United States, the CMS coverage determination represented a key execution milestone for the PARADIGM Trial, providing the reimbursement framework required to support patient enrollment and broader site-level adoption. Eligible procedures performed at participating U.S. study sites are covered under the Transcatheter Aortic Valve Replacement (TAVR) National Coverage Determination 20.32. With this reimbursement framework now in place, we expect U.S. site activation and patient recruitment activities to continue advancing as additional centers begin contributing to trial execution. Financial Results The financial results for Anteris for the quarter ended June 30, 2026, are presented below. All amounts in $ refer to U.S. dollars. The Company’s net operating cash outflows for the three months ended June 30, 2026 were $20.8 million, primarily attributable to clinical, regulatory and manufacturing requirements to support the PARADIGM Trial. Operating expenditures reflected the phased execution of the clinical program during the quarter, including the timing of U.S. site activation activities following receipt of the CMS coverage determination in April 2026. R&D expenses of $23.4 million were driven by the scaling of manufacturing and quality capabilities, including process development and validation activities and expanded headcount, together with PARADIGM trial related activities, including clinical costs associated with patient enrollment and the scaling of our field-based clinical team. These costs were partly offset by reduced DurAVR® THV product research costs. Please see the detailed financial information contained in Anteris’ Quarterly Report on Form 10-Q for the quarter ended June 30, 2026. About the PARADIGM Trial The PARADIGM Trial is a prospective randomized controlled trial which will evaluate the safety and effectiveness of the DurAVR® Transcatheter Heart Valve (“THV”) compared to commercially available transcatheter aortic valve replacements (TAVRs). This head-to-head study will enroll approximately 1,000 patients in the ‘All Comers Randomized Cohort’ with 1:1 randomization of patients who will receive either the DurAVR® THV or TAVR using commercially available and approved THVs. The PARADIGM Trial will assess non-inferiority on a primary composite endpoint of all-cause mortality, all stroke and cardiovascular hospitalization at one year post procedure. For further information, please refer to ClinicalTrials.gov NCT07194265. About Anteris Anteris Technologies Global Corp. (NASDAQ: AVR, ASX: AVR) is a global healthcare company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function. Founded in Australia, with a significant presence in Minneapolis, USA, Anteris is a science-driven company with an experienced team of multidisciplinary professionals delivering restorative solutions to structural heart disease patients. Anteris’ lead product, the DurAVR® THV, was designed in collaboration with the world’s leading interventional cardiologists and cardiac surgeons to treat aortic stenosis – a potentially life-threatening condition resulting from the narrowing of the aortic valve. The balloon-expandable DurAVR® THV is the first biomimetic valve, which is shaped to mimic the performance of a healthy human aortic valve and aims to replicate normal aortic blood flow. DurAVR® THV is made using a single piece of molded ADAPT® tissue, Anteris’ patented anti-calcification tissue technology. ADAPT® tissue, which is FDA-cleared, has been used clinically for over 10 years and distributed for use in over 55,000 patients worldwide. The DurAVR® THV System is comprised of the DurAVR® valve, the ADAPT® tissue, and the balloon-expandable ComASUR® Delivery System. Forward-Looking Statements This announcement contains forward-looking statements, including, but not limited to, statements regarding the PARADIGM Trial, CMS reimbursement eligibility, clinical development timelines and potential commercialization. Forward-looking statements include all statements that are not historical facts. Forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “budget,” “target,” “aim,” “strategy,” “plan,” “guidance,” “outlook,” “may,” “should,” “could,” “will,” “would,” “will be,” “will continue,” “will likely result” and similar expressions, although not all forward-looking statements contain these identifying words. These forward-looking statements are subject to a number of risks, uncertainties, and assumptions, including those described under “Risk Factors” in Anteris’ Annual Report on Form 10-K for the fiscal period ended December 31, 2025 that was filed with the Securities and Exchange Commission and ASX. Actual future events may vary from these forward-looking statements and readers are cautioned not to put undue reliance on forward-looking statements. Other than as required by law, Anteris gives no representation or guarantee that the occurrence of any of the events or circumstances expressed or implied in these statements will occur. In addition, except as required by law, Anteris does not assume any obligation to update any of these forward-looking statements to conform these statements to actual results or revised expectations. For more information: Global Investor RelationsInvestor Relations (US)investors@anteristech.commchatterjee@bplifescience.comDebbie OrmsbyMalini Chatterjee, Ph.D.Anteris Technologies Global Corp.Blueprint Life Science Group+61 1300 550 310 | +61 7 3152 3200+1 917 330 4269 Websitewww.anteristech.comX@AnterisTechLinkedInhttps://www.linkedin.com/company/anteristech

Teleflex Medical OEM Launches as INGENYX to Empower Tomorrow’s MedTech Innovators

Combining leading in-house expertise with platform-enhancing investments to accelerate advances in engineering, innovation and manufacturing capabilities serving global medical device innovators Marks completion of acquisition by Montagu and Kohlberg PLYMOUTH, Minn., Aug. 04, 2026 (GLOBE NEWSWIRE) — INGENYX, formerly Teleflex Medical OEM, today announced its launch as an independent company following the completion of its acquisition by Montagu and Kohlberg and carve-out from Teleflex Incorporated (NYSE: TFX). The transaction was first announced on December 9, 2025. Rooted in more than 40 years of experience serving medical device manufacturers, INGENYX develops and manufactures custom-engineered interventional catheters and subassemblies, sutures, tubing, wiring, complex extrusion solutions, surgical fibers, and other advanced medical device technologies for customers worldwide. As an independent company, INGENYX is well-positioned to expand its engineering capabilities, accelerate innovation, and strengthen customer collaboration while continuing to deliver the expertise, quality, and reliability medical device manufacturers have come to expect. Greg Stotts, formerly the Chief Executive Officer of Teleflex Medical OEM, continues in that role at INGENYX, and Matt Jennings, Senior Operating Partner at Kohlberg, will serve as Executive Chairman of the Board. “Medical device companies face growing pressure to innovate faster while managing complexity, risk, and cost,” Jennings said. “INGENYX is uniquely positioned to meet that need by serving as a collaborative extension of our customers’ teams, combining design for manufacturability (DFM) methodology, and our proprietary intelligence databank with a deep understanding of the decisions that shape successful products.” Under the INGENYX brand, the company will expand its focus beyond traditional contract manufacturing development to help customers navigate increasingly complex product development, material selection, scalability, and lifecycle challenges. “INGENYX reflects both who we are and where we’re headed,” Stotts added. “For decades, we’ve helped medical device companies bring innovative products to market. As an independent company, we have an opportunity to invest further in the capabilities, expertise, and technologies that help our customers make smarter decisions and accelerate their path to commercialization and beyond.” Key highlights of INGENYX include: Continuity that customers can count on. The same trusted teams, expertise, and customer commitment that have defined the business for decades remain in place under the INGENYX brand.The agility of an independent company. As a standalone organization backed by Kohlberg and Montagu, INGENYX is positioned to move faster and accelerate investments in innovation, engineering, and manufacturing capabilities.A stronger platform for what’s next. With integrated real-world manufacturing expertise and DFM intelligence, INGENYX helps customers make more informed development decisions, reduce risk, accelerate commercialization, and prepare for future product generations. For more information, visit www.ingenyx.com. About INGENYXINGENYX is a leading development and manufacturing partner to global medical device innovators. For more than 40 years, the company has developed and supplied custom-engineered interventional catheter components and subassemblies, surgical fibers, sutures, and other advanced medical device technologies used across high-growth treatment areas, including structural heart, neurovascular, electrophysiology, and urology. Leveraging deep materials science expertise, complex extrusion capabilities, proprietary intelligence, and a vertically integrated operating model, INGENYX helps customers navigate critical decisions from concept through commercial readiness and future product generations. With seven state-of-the-art facilities across the United States, Ireland, and Mexico, INGENYX supports many of the world’s leading medical device companies, helping to bring life-changing technologies to market. About MontaguMontagu is a leading mid-market private equity firm, committed to finding and growing businesses that make the world work. Focusing on businesses with a must-have product or service in a structurally growing marketplace, Montagu brings proven growth capabilities to help companies achieve their ambitions and unlock their full potential. Montagu specializes in carve-out and other first-time buyout investments and has deep expertise in five priority sectors: Healthcare, Financial Sector Services, Critical Data, Digital Infrastructure, and Education. Environmental, Social, and Governance (ESG) forms an integral part of its strategy, and its commitment to responsible investment is fully integrated into its investment and value-creation process. Montagu has €15 billion in assets under management. For more information, visit www.montagu.com. About Kohlberg Founded in 1987, Kohlberg is a leading U.S. middle market investment firm based in Mount Kisco, New York with deep experience investing across private equity and credit. Informed by its thesis-driven White Paper Program, Kohlberg invests in healthcare and services companies characterized by strong brands, recurring revenue streams and leading market positions. Kohlberg manages approximately $17 billion on behalf of investors globally. For more information, please visit www.kohlberg.com. Media Contact:For INGENYXPatty Caballeropatty@pscconsulting.net973-348-5055 For MontaguJames Madsen, Bella LahdoGreenbrook+44 20 7952 2000montagu@greenbrookadvisory.com For KohlbergAmanda Shpiner/Jonathan WarrenGasthalter & Co.212-257-4170media@kohlberg.com

Galaxy Therapeutics Achieves CE Mark for SEAL™ Embolization System, Enabling Commercial Launch Across Europe and International Markets

MILPITAS, Calif., Aug. 4, 2026 /PRNewswire/ — Galaxy Therapeutics, a privately held medical device company dedicated to advancing the treatment of intracranial aneurysms, today announced that it has received CE Mark under the European Medical Device Regulation (EU MDR 2017/745) for the…

First Patient Enrolled in Penumbra’s FORWARD Study Evaluating Mechanical Thrombectomy and Computer Assisted Vacuum Thrombectomy for Distal Acute Ischemic Stroke

ALAMEDA, Calif., July 7, 2026 /PRNewswire/ — Penumbra, Inc. (NYSE: PEN), the world’s leading thrombectomy company, announced the initiation of its FORWARD study, an international, real world prospective, multi-center study. The study will collect safety and efficacy data on mechanical…

AnaCardio´s Phase 1b/2a GOAL-HF1 study in patients with Heart Failure and Reduced Ejection Fraction (HFrEF) published in The Lancet

STOCKHOLM, Sweden, June 25, 2026 – AnaCardio, a clinical stage biopharmaceutical company developing novel drugs to treat heart failure, today announced the publication in The Lancet of results from its Phase 1b/2a GOAL-HF1 study evaluating AC01, a first-in-class, oral calcium-sensitising contractile agent, in patients with heart failure with reduced ejection fraction (HFrEF). The results showed a favourable safety and tolerability profile, dose-proportional pharmacokinetics with confirmed target engagement. In exploratory efficacy analyses, numerical rapid and sustained improvements in haemodynamics and cardiac structure and function were observed on top of optimised guideline-directed medical therapy (GDMT).

PorTal Access, Inc. Announces Completion of FDA 510(k) Submission for Flexi-Port™, Marking Major Milestone Toward Commercial Launch

Mid-Summer Launch Anticipated for Next-Generation Oncology Vascular Access Platform MIAMI, May 18, 2026 /PRNewswire/ — PorTal Access, Inc., a medical device company pioneering next-generation vascular access solutions for oncology, today announced the successful completion of its U.S….