Coronary/Structural Heart

JSCAI at TCT 2026: TAVR Use Increased Nearly Ninefold Among Patients Under 70 in Health System Analysis

Annual TAVR procedures among patients younger than 70 rose from 15 in 2014 to 134 in 2024 within one health system, driven primarily by patients in their 60s, while surgery remained predominant. SAN DIEGO (November 3, 2026)—New research simultaneously published today in JSCAI and presented at TCT 2026 found that […]

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TCT26: Medtronic Symplicity blood pressure procedure shows significant blood pressure drops in SPYRAL AFFIRM real-world study

Nearly nine out of 10 patients experienced a clinical benefit at six months Medtronic receives FDA approval for U.S. labeling update to Symplicity blood pressure procedure, expanding clinical evidence informing treatment options GALWAY, Ireland and SAN DIEGO, Nov. 3, 2026 /PRNewswire/ — Medtronic plc, a global leader in healthcare technology, […]

Bayer to Present New Cardiovascular, Kidney and Stroke Data at the 2026 American Heart Association (AHA) Scientific Sessions

WHIPPANY, N.J.–(BUSINESS WIRE)–Bayer Summary Bayer today announced that new data from its cardiovascular, kidney and stroke portfolios will be featured at the American Heart Association Scientific Sessions in Chicago, Illinois from November 6-9, 2026. Key Facts A late-breaking oral presentation will feature data from an exploratory post-hoc analysis of the Phase 3 OCEANIC-STROKE study, which evaluated asundexian versus placebo, both in combination with antiplatelet therapy, in patients after

Humacyte Innovative Research in Coronary Bypass and Vascular Regeneration to be Highlighted at American Heart Association Scientific Sessions 2026

– Founder & CEO Laura Niklason, M.D., Ph.D., to deliver invited talk on engineering the microenvironment to accelerate vascular regeneration. – Two additional presentations to cover first-in-human Phase 2a study design and preclinical results for Humacyte’s investigational coronary tissue engineered vessel. DURHAM, N.C., Nov. 03, 2026 (GLOBE NEWSWIRE) — Humacyte, Inc. (Nasdaq: HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at a commercial scale, announced today that the Company’s regenerative medicine technology will be highlighted in three presentations at the American Heart Association (AHA) Scientific Sessions 2026. The conference will be taking place from November 6–9th at McCormick Place Convention Center in Chicago, Illinois. AHA Scientific Sessions is one of the world’s largest gatherings of cardiovascular clinicians and scientists. Humacyte’s presentations include an invited talk by the company’s Founder, President and Chief Executive Officer, Laura Niklason, M.D., Ph.D., and two presentations highlighting Humacyte’s investigational coronary tissue engineered vessel (CTEV), a small-diameter bioengineered vessel for coronary artery bypass grafting (CABG). “AHA brings together the cardiac surgeons and cardiologists who will ultimately decide whether an off-the-shelf conduit belongs in bypass surgery, and we are excited for them to see our preclinical data and our study design firsthand,” said Dr. Niklason. “Our approach is built on the idea that the body can repopulate an engineered vessel with a patient’s own cells. With the CTEV, we are taking the next step toward bringing bioengineered vascular technology to coronary bypass surgery through the first U.S. clinical trial of a bioengineered CABG conduit.” Presentation details: Invited Talk Title: Engineering the Microenvironment to Accelerate Vascular RegenerationPresenter: Laura E. Niklason, M.D., Ph.D., Founder and CEO, Humacyte, Inc.Date and time: Saturday, November 7, 2026, 10:15 AM CTLocation: North Hall, Level 3, McCormick Place, Chicago Clinical Study Design Title: First-in-Human Phase 2a Study Design of a Bioengineered Human Coronary Artery for Coronary Artery Bypass GraftingPresenters: John Alexander, M.D., M.H.S., Professor of Medicine/Cardiology, Duke Clinical Research Institute at Duke University and Alan Kypson, M.D., Cardiothoracic Surgeon, UNC Rex HospitalDate and time: Saturday, November 7, 2026, 3:57 PM CTSession/Location: Science and Technology Hall, Level 3, Clinical Science Zone 1, McCormick Place, Chicago Preclinical CABG Results Title: Evaluation of Tissue Engineered Human Vessels in Porcine and Ovine Models of Coronary Artery Bypass GraftingPresenter: Robert Kirkton, Ph.D., Executive Director of New Product and Process Development, Humacyte, Inc.Date and time: Sunday, November 8, 2026, 9:15 AM CTSession/Location: Science and Technology Hall, Level 3, Clinical Science Zone 2, McCormick Place, Chicago The CTEV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency. About Humacyte Humacyte, Inc. (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems designed to improve the lives of patients and transform the practice of medicine. The Company develops and manufactures acellular tissues to treat a wide range of diseases, injuries, and chronic conditions. Humacyte’s Biologics License Application for the acellular tissue engineered vessel (ATEV) in the vascular trauma indication was approved by the FDA in December 2024. ATEVs are also currently in late-stage clinical trials targeting other vascular applications, including arteriovenous (AV) access for hemodialysis and peripheral artery disease (PAD). Preclinical development is also underway in coronary artery bypass grafts, pediatric heart surgery, treatment of type 1 diabetes, and multiple novel cell and tissue applications. Humacyte’s 6mm ATEV for AV access in hemodialysis was the first product candidate to receive the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation and has also received FDA Fast Track designation. Humacyte’s 6mm ATEV for urgent arterial repair following extremity vascular trauma and for advanced PAD also have received RMAT designations. The ATEV received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense. For more information, visit www.Humacyte.com. For uses other than the FDA approval in the extremity vascular trauma indication, the ATEV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency. Forward-Looking Statements This press release contains forward-looking statements that are based on beliefs and assumptions and on information currently available. In some cases, you can identify forward-looking statements by the following words: “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties, and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this press release, we caution you that these statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. Forward-looking statements in this press release include, but are not limited to, our plans and ability to commercialize Symvess and, if approved by regulatory authorities, our product candidates, successfully and on our anticipated timelines; the degree of market acceptance of and the availability of third-party coverage and reimbursement for Symvess and, if approved by regulatory authorities, our product candidates; our ability to manufacture Symvess and, if approved by regulatory authorities, our product candidates in sufficient quantities to satisfy our clinical trial and commercial needs; the anticipated benefits of our ATEVs relative to existing alternatives; our plans and ability to execute product development, process development and preclinical development efforts successfully and on our anticipated timelines; our ability to design, initiate and successfully complete clinical trials and other studies for our product candidates and our plans and expectations regarding our ongoing or planned clinical trials; the anticipated characteristics and performance of our ATEVs; the implementation of our business model and strategic plans for our business; our ability to execute and achieve the expected benefits of our cost-saving measures and whether our efforts will result in further actions or additional asset impairment charges that adversely affect our business; and the timing or likelihood of regulatory filings, acceptances and approvals. We cannot assure you that the forward-looking statements in this press release will prove to be accurate. These forward-looking statements are subject to a number of significant risks and uncertainties that could cause actual results to differ materially from expected results, including, among others, changes in applicable laws or regulations, the possibility that Humacyte may be adversely affected by other economic, business, competitive and/or reputational factors, and other risks and uncertainties, including those described under the header “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2024 and Form 10-Q for the quarter ended March 31, 2025, each filed by Humacyte with the SEC, and in future SEC filings. Most of these factors are outside of Humacyte’s control and are difficult to predict. Furthermore, if the forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. Except as required by law, we have no current intention of updating any of the forward-looking statements in this press release. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release. Humacyte Investor Contact:Joyce AllaireLifeSci Advisors LLC+1-617-435-6602jallaire@lifesciadvisors.cominvestors@humacyte.com Humacyte Media Contact:Rich LuchettePrecision Strategies+1-202-845-3924rich@precisionstrategies.commedia@humacyte.com

Conavi Medical Presents Data Demonstrating Feasibility of Saline-Based Hybrid IVUS–OCT Imaging with OCTIV™ at TCT 2026

Study demonstrates feasibility of saline-based hybrid IVUS-OCT imaging without iodinated contrast during image acquisitionFDA-cleared OCTIV system now in commercial clinical use, with patient cases ongoing TORONTO, Nov. 03, 2026 (GLOBE NEWSWIRE) — Conavi Medical Corp. (TSXV: CNVI) (OTCQB: CNVIF) (“Conavi” or the “Company”), a commercial-stage medical device company developing imaging technologies to guide cardiovascular procedures, today announced the presentation of data from its OCTIV™ hybrid IVUS–OCT imaging system at Transcatheter Cardiovascular Therapeutics (“TCT”) 2026. The study, conducted in an animal model before OCTIV’s use in patients, demonstrated the feasibility of using saline instead of iodinated contrast during image acquisition. The FDA-cleared system is now in commercial clinical use, with its first U.S. placement completed and patient cases ongoing. The findings were presented by Megha Prasad, MD, MS, in an abstract titled “Saline-Based Hybrid IVUS-OCT Imaging: Feasibility of Contrast-Free Dual-Modality Intracoronary Imaging in a Porcine Model.” “These findings highlight the potential of OCTIV to provide complementary ultrasound and optical images using saline, eliminating the need for iodinated contrast during image acquisition,” said Thomas Looby, President and Chief Executive Officer of Conavi Medical. “Since this study was conducted, OCTIV has advanced into commercial clinical use, with our first U.S. placement completed and patient cases ongoing. We are pleased to share these results as we build clinical experience with the system.” Study Results The prospective feasibility study evaluated hybrid intravascular ultrasound (“IVUS”) and optical coherence tomography (“OCT”) imaging of major coronary arteries in three swine, using saline as the sole OCT flushing medium. Investigators performed 26 imaging pullbacks in native vessels and following stent placement, assessing feasibility, safety, catheter performance and image quality. Key findings included: Interpretable images across all 26 pullbacks: Hybrid imaging was successfully performed in all targeted vessels without iodinated contrast during image acquisition.Complementary vessel assessment: OCT provided high-resolution visualization of luminal morphology and stent architecture, while IVUS enabled assessment of vessel dimensions and deeper wall structures within the same pullback.Continuous IVUS imaging: IVUS assessment remained available independently of blood clearance, with high-resolution OCT visualization achieved when saline flushing was adequate.No observed device-related complications: No device-related complications, coronary injury, sustained arrhythmia or procedural mortality occurred.Potential to eliminate iodinated contrast during image acquisition: The findings support further clinical evaluation of saline-based hybrid imaging, which could be particularly relevant for patients at risk of contrast-associated acute kidney injury.   About Conavi MedicalConavi Medical is focused on designing, manufacturing, and marketing imaging technologies to guide common minimally invasive cardiovascular procedures. Its patented OCTIV hybrid imaging system is the first system to co-register and co-align intravascular ultrasound (IVUS) and optical coherence tomography (OCT) imaging beams to enable simultaneous hybrid imaging of coronary arteries. The hybrid imaging system has 510(k) clearance from the U.S. Food and Drug Administration. For more information, visit http://www.conavi.com/. Forward-Looking StatementsThis press release includes forward-looking information or forward-looking statements within the meaning of applicable securities laws regarding the Company and its business, which may include, but are not limited to, statements with respect to the anticipated clinical benefits and performance of OCTIV, continued clinical use, placements at additional U.S. institutions, participation in TCT 2026, the commercialization and commercial launch of Conavi’s hybrid imaging system and the timing thereof, the sufficiency of Conavi’s resources to achieve such commercial launch, the global market opportunity for coronary intravascular imaging (including for IVUS and OCT), the continued growth in adoption of and in the clinical validation and guideline support for intravascular imaging and the ability of Conavi’s hybrid imaging system to meet market needs. All statements that are, or information which is, not historical facts, including without limitation, statements regarding future estimates, plans, programs, forecasts, projections, objectives, assumptions, expectations or beliefs of future performance, are “forward-looking information or statements”. Often but not always, forward-looking information or statements can be identified by the use of words such as “shall”, “intends”, “anticipate”, “believe”, “plan”, “expect”, “intend”, “estimate” or any variations (including negative variations) of such words and phrases, or state that certain actions, events or results “may”, “might”, “can”, “could”, “would” or “will” be taken, occur, lead to, result in, or, be achieved. Such statements are based on the current expectations and views of future events of the management of the Company. They are based on assumptions and subject to risks and uncertainties. Although management believes that the assumptions underlying these statements are reasonable, they may prove to be incorrect. The forward-looking events and circumstances discussed in this release, may not occur and could differ materially as a result of known and unknown risk factors and uncertainties affecting the Company, including, without limitation, those listed in the “Risk Factors” section of the annual information form of the Company dated February 26, 2026 (available on the Company’s profile at www.sedarplus.ca). Although the Company has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. Accordingly, readers should not place undue reliance on any forward-looking statements or information. No forward-looking statement can be guaranteed. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and the Company does not undertake any obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise. No regulatory authority has approved or disapproved the content of this press release. Neither the TSX Venture Exchange nor its Regulatory Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this press release. ContactMark Quick, Chief Financial Officer | 416-483-0100Christina Cameron, Investor Relations | 416-483-0100 ext. 121 | IR@conavi.comSusan Thomas, Media | 619-540-9195

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Majority of Patients with Moderate Aortic Stenosis Carry Features Linked to Twice the Risk of Death, egnite Registry Study Finds

The analysis, published simultaneously in JACC, found that moderate AS patients with at least one at-risk feature had a two-fold increase in mortality and hospitalization with heart failure compared with moderate AS patients with no at-risk features over two years. Dr. Philippe Généreux…

Blackstone Life Sciences Announces $455 Million Collaboration to Co-Fund Development of Boston Scientific VITALYST™ Heart Pump for Patients with Cardiogenic Shock

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Blackstone Life Sciences (“BXLS”) today announced a $455 million collaboration with Boston Scientific Corporation (NYSE: BSX) to co-fund the development of the VITALYST™ Temporary Percutaneous Transvalvular Circulatory Support System program. The VITALYST system is a next-generation, miniature heart pump intended to increase cardiac output and improve blood flow from the heart to the brain and other vital organs. It is designed to treat acute myocardial infarc

Progress Trial Demonstrates Edwards TAVR Is Superior to Clinical Surveillance for Moderate AS Patients With At-Risk Features

SAN DIEGO–(BUSINESS WIRE)–Edwards Lifesciences (NYSE: EW) today announced results from the PROGRESS Trial, marking a turning point in the management of moderate aortic stenosis (AS). The trial demonstrated that transcatheter aortic valve replacement (TAVR) was superior to clinical surveillance in the primary composite endpoint of death or heart failure events at two years in moderate AS patients with at-risk features. The late-breaking results were presented at Transcatheter Cardiovascular Th