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TCT 2026 Clinical Data Reveals 84% Reporting Gap in Aortic Valve Calcification, Highlighting the Potential of Nanox.AI’s AVC Solution

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TIME Best Inventions 2026

TIME Best Inventions 2026

Nanox.AI’s Investigational AVC Solution Demonstrated 98.3% Sensitivity and 96.6% Specificity in Evaluable CT Scans.Findings Highlight the Potential of AI to Identify Previously Unreported Aortic Valve Calcification Using Existing Routine CT Scans.Findings published in the peer-reviewed journal JACC: Advances. PETACH TIKVA, Israel, Nov. 2, 2026 (GLOBE NEWSWIRE) — Nanox Imaging Ltd. (“Nanox” or the “Company”, NASDAQ: NNOX), a leader in innovative medical imaging technology, today announced that updated clinical data on Nanox AI Ltd’s (“Nanox.AI”) aortic valve calcification (AVC) AI solution was presented at the Transcatheter Cardiovascular Therapeutics (TCT) Conference, taking place October 31 to November 3, 2026, in San Diego, California. Nanox.AI’s HealthAVC solution is intended to serve as a non-invasive, post-processing software application that detects and quantifies calcified plaques in the aortic valve. The software analyzes non-gated, non-contrast chest computed tomography (CT) images acquired during routine clinical care and provides a numeric aortic valve calcium score, a sex-based categorization, and a visual indication of the result. The HealthAVC device is being developed for the use by clinicians to assist in the detection and quantification of aortic valve calcification, supporting early identification of patients who may benefit from cardiovascular evaluation, ongoing monitoring, and potential consideration for TAVR. The solution is under development and is not yet cleared for clinical use or commercially available. “The low reporting rate may reflect the fact that most CT scans were performed for unrelated indications, alongside challenges in assessing aortic valve calcification and the lack of clearly defined clinical pathways for incidental findings,” said Ofir Koren, MD, FACC, FESC, Assistant Professor of Cardiology, Director, Cardiovascular Innovation Program of Cedars-Sinai Medical Center, consultant to Nanox.AI and lead author of the study. “AI-based clinical decision support could help address these challenges by providing consistent detection and quantitative assessment, potentially improving the recognition and reporting of AVC in routine practice. At the same time, we need to establish clearer, evidence-based recommendations for further evaluation and follow-up, particularly for patients with high calcium burden or findings suggestive of severe aortic stenosis.” The data was also published in the Journal of the American College of Cardiology (JACC). The TCT abstract, “AI-Detected Aortic Valve Calcification on Routine Chest CT Reveals a Large Hidden Population at Risk for Severe Aortic Stenosis,” was presented by Ofir Koren on Sunday, November 1, 2026. The study analyzed non-contrast chest CT from 440 evaluable adults aged 50 and older and compared AI findings with routine radiology reports. Key findings highlight an opportunity for AI-assisted detection A substantial documentation gap: 145 of 172 manually confirmed AVC-positive scans (84.3%) did not explicitly mention AVC in the original radiology report. This is a reporting measure, not a radiologists’ diagnostic-error rate.Detection of undocumented AVC: HealthAVC V1.0 identified 142 of these 145 cases (97.9%). Across all 440 evaluable scans, sensitivity was 98.3% (169/172) and specificity was 96.6% (259/268).Important workflow limitation: 56 of 496 submitted scans (11.3%) were non-evaluable. Counting manually positive rejected scans as missed yielded end-to-end sensitivity of 89.9% (169/188).Broader clinical context: Expert manual scoring identified two cases meeting sex-specific severe AVC thresholds. Among 86 AI-positive patients with clinically obtained echocardiography within ±365 days, 10 had mild-or-greater aortic stenosis. These selected data do not establish clinical benefit or a need for intervention. Nanox.AI’s HealthAVC solution will be highlighted at the RSNA 2026 Annual Meeting on the Innovation Theater; Tuesday, December 1 | 11:00am Schedule a meeting with Nanox at RSNA 2026| Booth #1759: https://www.nanox.vision/rsna2026 About Nanox Nanox (NASDAQ: NNOX) is focused on driving the world’s transition to preventive health care by delivering an integrated, end-to-end medical imaging and healthcare services platform. Nanox combines affordable imaging hardware, advanced AI-based solutions, cloud-based software, access to remote radiology, health IT solutions, and a marketplace to enable earlier detection, improved clinical efficiency, and broader access to care. Nanox’s vision is to expand the reach of medical imaging both within and beyond traditional hospital settings by providing a seamless solution from scan to interpretation and beyond. By leveraging proprietary digital X-ray technology, AI-driven analytics, and a clinically driven approach, Nanox aims to enhance the efficiency of routine imaging workflows, support early detection of disease, and improve patient outcomes. The Nanox ecosystem includes Nanox.ARC X, a multi-source digital tomosynthesis system designed to make advanced 3D imaging accessible in more clinical settings; Nanox.AI, a suite of AI-based algorithms that augment the interpretation of routine CT imaging to identify early signs often associated with chronic disease; Nanox.CLOUD, a cloud-based platform for secure data management, storage, and advanced imaging analytics; Nanox.MARKETPLACE and USARAD Holdings, which provides access to remote radiology and cardiology experts and comprehensive teleradiology services; and Nanox Health IT combines deep healthcare IT expertise with leading technology partners to deliver RIS, PACS, AI, dictation, and secure infrastructure solutions that streamline workflows and support safer, more efficient care delivery. The Nanox.ARC X was selected as one of TIME’s Best Inventions of 2026. By integrating imaging technology, AI, cloud infrastructure, clinical expertise, a marketplace, and health information technology, Nanox seeks to lower barriers to adoption, improve utilization, and advance preventive care worldwide. For more information, please visit https://www.nanox.vision. About Nanox.AI Nanox.AI is the deep-learning medical imaging analytics subsidiary of Nanox. Nanox.AI solutions are developed to target highly prevalent chronic and acute diseases affecting large populations around the world. Leveraging AI, Nanox.AI helps clinicians extract valuable and actionable clinical insights from medical imaging that otherwise may go unnoticed, potentially initiating further medical assessment to establish individual preventative care pathways for patients. For more information, please visit www.nanox.vision/ai. Forward-Looking Statements This press release may contain forward-looking statements that are subject to risks and uncertainties. All statements that are not historical facts contained in this press release are forward-looking statements. Such statements include, but are not limited to, any statements relating to the initiation, timing, progress and results of the Company’s research and development, manufacturing, and commercialization activities with respect to its X-ray source technology and the Nanox.ARC, the ability to realize the expected benefits of its recent acquisitions and the projected business prospects of the Company and the acquired companies. In some cases, you can identify forward-looking statements by terminology such as “can,” “might,” “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “,” “could,” “expect,” “predict,” “potential,” or the negative of these terms or other similar expressions. Forward-looking statements are based on information the Company has when those statements are made or management’s good faith belief as of that time with respect to future events and are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking statements. Factors that could cause actual results to differ materially from those currently anticipated include: risks related to (i) Nanox’s ability to complete development of the Nanox System; (ii) Nanox’s ability to successfully demonstrate the feasibility of its technology for commercial applications; (iii) Nanox’s history of recurring losses and negative cash flows from operating activities, significant future commitments and the uncertainty regarding the adequacy of Nanox’s liquidity to pursue its complete business objectives, and substantial doubt regarding its ability to continue as a going concern; (iv) Nanox’s expectations regarding the necessity of, timing of filing for, and receipt and maintenance of, regulatory clearances or approvals regarding its technology, the Nanox.ARC and Nanox.CLOUD from regulatory agencies worldwide and its ongoing compliance with applicable quality standards and regulatory requirements; (v) Nanox’s ability to realize the anticipated benefits of the acquisitions, which may be affected by, among other things, competition, brand recognition, the ability of the acquired companies to grow and manage growth profitably and retain their key employees; (vi) Nanox’s ability to enter into and maintain commercially reasonable arrangements with third-party manufacturers and suppliers to manufacture the Nanox.ARC; (vii) the market acceptance of the Nanox System and the proposed pay-per-scan business model; (viii) Nanox’s expectations regarding collaborations with third-parties and their potential benefits; (ix) Nanox’s ability to conduct business globally; (x) changes in global, political, economic, business, competitive, market and regulatory forces; (xi) risks related to the current war between Israel and Hamas and any worsening of the situation in Israel; (xii) risks related to business interruptions resulting from the COVID-19 pandemic or similar public health crises, among other things; and (xiii) potential litigation associated with our transactions. For a discussion of other risks and uncertainties, and other important factors, any of which could cause Nanox’s actual results to differ from those contained in the Forward-Looking Statements, see the section titled “Risk Factors” in Nanox’s Annual Report on Form 20-F for the year ended December 31, 2025, and subsequent filings with the U.S. Securities and Exchange Commission. The reader should not place undue reliance on any forward-looking statements included in this press release. Except as required by law, Nanox undertakes no obligation to update publicly any forward-looking statements after the date of this press release to conform these statements to actual results or to changes in the Company’s expectations. Contacts Media Contact:Ben ShannonICR HealthcareNanoxPR@icrinc.com Investor Contact:Mike CavanaughICR Healthcaremike.cavanaugh@icrhealthcare.com
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TIME Best Inventions 2026

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Orchestra BioMed Exceeds Full Enrollment Target in the BACKBEAT Global Pivotal Trial of AVIM Therapy

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330 patients randomized as of September 30, 2026, surpassing full trial enrollment targetCompany reiterates prior guidance: primary endpoint data to be submitted for late-breaking presentation consideration at a major cardiovascular conference in Q2 2027 Data expected to support future marketing application submissions by Medtronic to the FDA and other global regulatory agencies NEW HOPE, Pa., Oct. 01, 2026 (GLOBE NEWSWIRE) — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO) (“Orchestra BioMed” or the “Company”), a biomedical company accelerating high-impact technologies to patients through strategic partnerships with market-leading medical device companies, today announced that it has surpassed full enrollment in the BACKBEAT Global Pivotal Trial (“BACKBEAT Trial”), exceeding its previously announced target of 316 randomized patients. The BACKBEAT Trial is evaluating Atrioventricular Interval Modulation Therapy (“AVIM Therapy”) in pacemaker-indicated patients with uncontrolled hypertension despite the use of medication. Hypertension is the most common modifiable risk factor for death worldwide and the most common comorbidity among the pacemaker population.1 The BACKBEAT Trial (NCT06059638) is being conducted with Medtronic plc (“Medtronic”), the Company’s strategic collaborator for the BACKBEAT Trial and, subject to regulatory approval, for the commercialization of AVIM Therapy in pacemaker-indicated patients with uncontrolled hypertension despite the use of medication. As of September 30, 2026, 330 patients have been randomized in the BACKBEAT Trial at 81 sites across 13 countries.The BACKBEAT Trial’s protocol, approved by the U.S. Food and Drug Administration (the “FDA”), specifies 284 evaluable randomized subjects for the primary endpoint analysis, with a total enrollment target of 316 patients to account for potential loss to follow-up. The BACKBEAT Trial is a global, multi-center, prospective, randomized, double-blind pivotal trial. Patients are randomized 1:1 to AVIM Therapy combined with continued medical therapy and pacing (treatment) or continued medical therapy and standard pacing alone (control). The primary efficacy endpoint of the BACKBEAT Trial is the between-group difference in the change in 24-hour ambulatory systolic blood pressure (“aSBP”) at three-month follow-up from pre-randomization baseline. The primary safety endpoint is freedom from unanticipated serious adverse device events in the AVIM Therapy arm at three-month follow-up. The protocol-specified sample size provides greater than 90% statistical power for both primary endpoints and is designed to detect a between-group difference of at least 5 mmHg in aSBP. David Hochman, Chairman & Chief Executive Officer of Orchestra BioMed, commented, “Achieving and surpassing full enrollment of the BACKBEAT Trial is a defining milestone for Orchestra BioMed, for our collaboration with Medtronic and potentially for the millions of high cardiovascular risk patients who remain above blood pressure target despite the medications available to them today. We are grateful for and excited about the enrollment momentum built across our global trial site network over the last year. I want to thank the patients and their families who chose to participate, and the clinical teams and investigators at our trial sites globally whose commitment made this milestone possible. Our focus now turns to completing three-month follow-up, database lock, and the delivery of a rigorous, well-powered data set next spring.” Robert C. Kowal, M.D., Ph.D., Vice President and General Manager for Cardiac Pacing Therapies in the Medtronic Electrophysiology Therapies operating unit, stated, “For decades, cardiac pacing has been foundational in the management of rhythm disorders. Reaching full enrollment in the BACKBEAT Trial brings us a big step closer to understanding whether AVIM Therapy can extend the role of cardiac pacing therapy to include hypertension management for patients at increased cardiovascular risk. We are proud of the collaborative work our team and Orchestra BioMed’s team have done alongside investigators around the world, and we look forward to the primary endpoint results.” Vivek Reddy, M.D., Executive Chairman of the BACKBEAT Clinical Steering Committee, Director of Cardiac Arrhythmia Services at The Mount Sinai Fuster Heart Hospital and Director of Electrophysiology for the Mount Sinai Health System, commented, “Randomized, double-blind evidence is the highest standard by which a new therapeutic modality earns its place in clinical practice, and that is exactly what the BACKBEAT Trial was designed to generate. The pilot data for AVIM Therapy have been exciting, consistent and mechanistically coherent, but the field needs a pivotal trial to answer the question definitively. On behalf of the Steering Committee, I want to recognize the investigators, coordinators and other professionals whose work enabled the trial to reach full enrollment, and I look forward to seeing the three-month primary endpoint results.” Clinical, Regulatory and Commercial Next Steps Orchestra BioMed and Medtronic intend to submit the BACKBEAT Trial’s primary endpoint results for consideration as a late-breaking clinical trial presentation at a major cardiovascular conference in the second quarter of 2027. Assuming positive results from the BACKBEAT Trial, Medtronic plans to submit AVIM Therapy marketing applications to the FDA and other global regulatory agencies promptly. About Orchestra BioMed Orchestra BioMed is a biomedical innovation company accelerating high-impact technologies to patients through strategic collaborations with market-leading global medical device companies. The Company’s two flagship product candidates, Atrioventricular Interval Modulation (AVIM) Therapy and Virtue Sirolimus AngioInfusion Balloon (Virtue SAB), are currently undergoing pivotal clinical trials for their lead indications, each representing multi-billion-dollar annual global market opportunities. AVIM Therapy is a bioelectronic treatment for hypertension, the leading risk factor for death worldwide, and is designed to be delivered by a pacemaker and achieve immediate, substantial and sustained reductions in blood pressure in patients with hypertensive heart disease. The Company has a strategic collaboration with Medtronic, one of the largest medical device companies in the world and the global leader in cardiac pacing therapies, for the development and commercialization of AVIM Therapy for the treatment of uncontrolled hypertension in pacemaker-indicated patients. AVIM Therapy has FDA Breakthrough Device Designations for these patients, as well as an estimated 7.7 million total patients in the U.S. with uncontrolled hypertension despite medical therapy and increased cardiovascular risk. Virtue SAB is a highly differentiated, first-of-its-kind non-coated drug delivery angioplasty balloon system designed to deliver a large liquid dose of proprietary extended-release formulation of sirolimus, SirolimusEFR™, for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide. Virtue SAB has been granted Breakthrough Device Designation by the FDA for the treatment of coronary in-stent restenosis, coronary small vessel disease and below-the-knee peripheral artery disease. For further information about Orchestra BioMed, please visit www.orchestrabiomed.com, and follow us on LinkedIn. About AVIM Therapy AVIM Therapy is an investigational therapy compatible with standard dual-chamber pacemakers designed to substantially and persistently lower blood pressure. It has been evaluated in pilot studies in patients with hypertension who are also indicated for a pacemaker. In MODERATO II, a double-blind, randomized pilot study, AVIM Therapy-treated patients had a mean reduction of 11.1 mmHg in 24-hour ambulatory systolic blood pressure (aSBP) from pre-randomization baseline at six months, representing a net reduction of 8.1 mmHg versus control patients. At the same time point, the net reduction in office systolic blood pressure (oSBP) was 12.3 mmHg versus control. Additional MODERATO II data showed an immediate mean oSBP reduction of 13.2 mmHg when AVIM Therapy was activated during setup before randomization, with 97% of patients achieving a reduction of at least 5 mmHg. In addition to reducing blood pressure, clinical results using AVIM Therapy demonstrate improvements in cardiac function and hemodynamics. The BACKBEAT (BradycArdia paCemaKer with atrioventricular interval modulation for Blood prEssure treAtmenT) global pivotal trial is evaluating the safety and efficacy of AVIM Therapy in lowering blood pressure in patients who have systolic blood pressure above target despite anti-hypertensive medication and who are indicated for or have recently received a dual-chamber cardiac pacemaker. AVIM Therapy has been granted two Breakthrough Device Designations by the FDA for the treatment of uncontrolled hypertension in patients who have increased cardiovascular risk. Forward-Looking Statements Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements relating to the timing, implementation, results and design of the Company’s ongoing pivotal trials, the timing of regulatory submissions, realizing the clinical and commercial value of the Company’s product candidates, the potential safety and efficacy of the Company’s product candidates, the size of the potential markets for the Company’s product candidates, and the ability of the Company’s partnerships to accelerate clinical development. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of the Company’s management and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as and must not be relied on as a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and may differ from assumptions. Many actual events and circumstances are beyond the control of the Company. These forward-looking statements are subject to a number of risks and uncertainties, including changes in domestic and foreign business, market, financial, political, and legal conditions; risks related to regulatory approval of the Company’s commercial product candidates and ongoing regulation of the Company’s product candidates, if approved; the timing of, and the Company’s ability to achieve expected regulatory and business milestones; the impact of competitive products and product candidates; and the risk factors discussed under the heading “Item 1A. Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, which was filed with the SEC on March 12, 2026. The Company operates in a very competitive and rapidly changing environment. New risks emerge from time to time. Given these risks and uncertainties, the Company cautions against placing undue reliance on these forward-looking statements, which only speak as of the date of this press release. The Company does not plan and undertakes no obligation to update any of the forward-looking statements made herein, except as required by law. Investor Contact:Silas NewcombOrchestra BioMedsnewcomb@orchestrabiomed.com Media Contact:Nina PremuticoOrchestra BioMednpremutico@orchestrabiomed.com 1 World Health Organization, Global Report on Hypertension 2025 (an estimated 1.4B adults aged 30–79 with hypertension in 2024, 33% of that age group; ~23% of those living with hypertension have their blood pressure effectively controlled).

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

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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, […]

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Anteris Technologies Announces Results for the Second Quarter of 2026

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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

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

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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

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

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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…

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

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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…

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