The Latest Cardiac and Vascular News
AQUAPASS ECCON™ System delivered a >7x increase in net fluid loss in congested heart failure patients not responding to high-dose diuretics, with a consistently high responder rate (91%) and no device-related adverse events NEWTON, Mass., Nov. 5, 2026: AQUAPASS Medical, developer of a noninvasive, kidney-independent therapy, announced that the REFORM-HF […]
NEW HOPE, Pa., Nov. 05, 2026 (GLOBE NEWSWIRE) — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO) (“Orchestra BioMed” or the “Company”), a biomedical innovation company accelerating high-impact technologies to patients through strategic collaborations with market-leading global medical device companies, announced today that it has commenced an underwritten public offering of shares of its common stock (the “Offering”). All of the securities are being offered by the Company. In addition, the Company intends to grant the underwriters a 30-day option to purchase up to an additional 15% of shares of its common stock sold in the Offering at the public offering price per share, less underwriting discounts and commissions. The Offering is subject to market and other conditions, and there can be no assurance as to whether or when the Offering may be completed, or as to the actual size or terms of the Offering. The Company intends to use the net proceeds it receives from the Offering, together with its existing cash and cash equivalents, to fund the Company’s Atrioventricular Interval Modulation Therapy (“AVIM Therapy”) program and the execution of the BACKBEAT global pivotal trial involving patients with uncontrolled hypertension who are indicated for a dual-chamber pacemaker (the “Backbeat Trial”) and to fund its Virtue® Sirolimus AngioInfusion Balloon (“Virtue SAB”) program and the Virtue SAB in the Treatment of Coronary In-Stent Restenosis Trial (the “Virtue Trial”), as well as research and clinical development of other current or additional product candidates, and the remainder for working capital and other general corporate purposes. Piper Sandler and TD Cowen are acting as joint bookrunning managers for the Offering. BTIG is acting as a bookrunner. The securities described above are being offered pursuant to a shelf registration statement on Form S-3 (File No. 333-279430) that was filed with the Securities and Exchange Commission (the “SEC”) on May 15, 2024 and declared effective on May 24, 2024. The Offering is being made only by means of a prospectus supplement and an accompanying prospectus that form a part of the registration statement. A preliminary prospectus supplement related to and describing the terms of the Offering will be filed with the SEC and will be available on the SEC’s website located at www.sec.gov. Copies of the preliminary prospectus supplement and an accompanying prospectus related to the Offering may also be obtained, when available, from: Piper Sandler & Co., Attention: Prospectus Department, 350 North 5th Street, Suite 1000, Minneapolis, Minnesota 55401, or by telephone at (800) 747-3924, or by email at prospectus@psc.com; or TD Securities (USA) LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, or by email at TDManualrequest@broadridge.com. This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. 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 – AVIM Therapy and Virtue SAB – are currently undergoing pivotal clinical trials for their lead indications. 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 (NYSE: MDT), 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 two FDA Breakthrough Device Designations. The BACKBEAT Trial evaluating AVIM Therapy in this population has completed enrollment. Virtue SAB is a first-of-its-kind, non-coated drug delivery AngioInfusion™ balloon system designed to infuse 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 exceeded the published pharmacokinetics of leading limus drug-eluting stents and demonstrated positive three-year clinical data in coronary In-Stent Restenosis in the SABRE study, a multi-center prospective, independent core lab-adjudicated pilot clinical study of 50 patients conducted in Europe. 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, in each case, within specified parameters. The Virtue Trial is currently enrolling patients. 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 regarding the proposed Offering, including the completion and timing of the Offering, the anticipated use of proceeds from the Offering and the expectation to grant the underwriters a 30-day option to purchase additional shares . 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, as such discussion may be updated from time to time by subsequent filings the Company may make with the SEC, as well as the risks identified in the registration statement and the preliminary prospectus supplement relating to the Offering. 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 ContactSilas NewcombOrchestra BioMedsnewcomb@orchestrabiomed.com Media ContactNina PremuticoOrchestra BioMednpremutico@orchestrabiomed.com
DENVER–(BUSINESS WIRE)– #AI–Cleerly, a leader in AI-based cardiovascular imaging, announces its participation in the American Heart Association (AHA) Scientific Sessions 2026, November 6 to 9 at McCormick Place Convention Center in Chicago, Illinois. Cleerly will share primary results from PARAMOUNT, the first randomized trial to compare personalized care guided by AI-based quantitative coronary CT analysis (AI-QCT) with usual care in symptomatic patients with suspected coronary artery disease (CA
Published study reports PulseAI model delivers up to 10x performance improvement when used with leading wearables BELFAST, Northern Ireland, Nov. 5, 2026 /PRNewswire/ –PulseAI, a medical technology company developing artificial intelligence for cardiac diagnostics, today announced U.S….
The 6-month target lesion primary patency (TLPP)1 and access circuit primary patency (ACPP)2 for patients in the arteriovenous fistula (AVF) cohort were 92.7% and 76.7%, respectivelyThe real-world patency results observed in the WRAP Global Registry are higher than the patency results from the WRAPSODY Arteriovenous Access Efficacy (WAVE) pivotal trial, validating the already favorable performance of the device SOUTH JORDAN, Utah, Nov. 05, 2026 (GLOBE NEWSWIRE) — Merit Medical Systems, Inc. (NASDAQ: MMSI), a global leader of healthcare technology, today announced results from the AVF cohort of the WRAPSODY (WRAP) Global registry. Clinical data were presented during the New Innovations, Trials, Techniques & Devices session on Saturday, October 31, 2026, at the Controversies in Dialysis Access (CiDA)* conference held in Washington, DC. Hemodialysis is a life-sustaining therapy for patients diagnosed with advanced kidney disease. For many patients, the creation and long-term maintenance of an AVF is essential for ongoing access to blood vessels (vascular access). However, impairments in and around the fistula due to progressive narrowing (stenosis) and/or blockage (occlusion) are inevitable for some patients. These obstructions can interfere with a patient’s ability to receive hemodialysis, require repeated interventions, and may result in life-threatening consequences. The WRAPSODY™ Cell-Impermeable Endoprosthesis (CIE) was developed to restore functionality in vascular access in patients who experience stenosis/occlusion. The device’s favorable performance has been documented in the clinical trial setting.3–6 Real-world data provide insight into how a medical device performs when used in routine clinical practice, outside the controlled setting of a traditional clinical trial. The WRAP Global registry is an international, multicenter, prospective study designed to evaluate the performance of the WRAPSODY CIE in real-world clinical practice through 24 months following device placement. A total of 237 patients were enrolled in the AVF cohort across 31 sites in nine countries. The 6-month TLPP1 was 92.7%, and the 6-month ACPP2 was 76.7%. These findings align with the patency rates observed in the AVF cohort in the WAVE pivotal trial (6-month TLPP: 89.8%; 6-month ACPP: 72.8%).4 “These are the results physicians have been waiting for,” said Panagiotis M. Kitrou, MD, MSc, PhD, EBIR, FCIRSE, Co-Global Principal Investigator of the WRAP Global registry, Associate Professor of Interventional Radiology at Patras University Hospital in Patras, Greece, and a clinical consultant to Merit Medical. “Real-world insight regarding the patency of WRAPSODY provides an important benchmark for this patient population.” “The promising patency outcomes from the WRAP Global registry are likely to improve physician confidence in the clinical benefits associated with WRAPSODY and help to further optimize patient care,” said Dheeraj K. Rajan, MD, Co-Global Principal Investigator of the WRAP Global registry, Professor and Division Head in the Department of Vascular Interventional Radiology at the University of Toronto in Toronto, Canada, who also serves as a clinical advisor to Merit Medical. “These results reinforce our commitment to building a comprehensive body of clinical evidence for WRAPSODY, which includes both rigorous clinical trials and real-world practice,” said Martha G. Aronson, Merit’s President and Chief Executive Officer. “Helping physicians maintain vascular access and reduce the burden associated with repeat interventions is central to what we are working to achieve for patients receiving hemodialysis worldwide.” The WRAPSODY CIE received premarket approval from the U.S. Food and Drug Administration (FDA) in December 2024 and was approved by Health Canada in April 2025. In January 2025, Merit began commercialization of the device in the United States. The device previously received the Conformité Européenne (CE) Mark for commercial use in the European Union and is available in Brazil. In addition to the WRAP Global registry, real-world clinical outcomes of the WRAPSODY CIE are being evaluated in the WRAP North America registry, which is designed to enroll up to 250 patients in the United States and Canada. For additional information on Merit’s WRAP North America registry, please visit: https://clinicaltrials.gov/study/NCT06807099. Merit believes that the collective data from the WAVE trial, the WRAP North America registry, and the WRAP Global registry will generate evidence on the largest cohort of patients for a single indication in dialysis access to date. For more information on the WRAPSODY CIE within the United States, please visit: https://www.merit.com/product/wrapsody-cie/. For information on the device outside of the United States, please visit: https://www.merit.com/product/merit-wrapsody/. Cautionary statement regarding forward-looking statements Any forward-looking statements set forth in this release are subject to risks and uncertainties such as those described in Merit’s filings with the U. S. Securities and Exchange Commission (“SEC”). For discussion of the risks and uncertainties which may affect Merit’s business, operations and financial condition, see Part I, Item 1A, “Risk Factors” in Merit’s Annual Report on Form 10-K for the year ended December 31, 2025 filed with the SEC, which Merit updated in Part II, Item 1A, “Risk Factors” in Merit’s Quarterly Reports on Form 10-Q for the quarters ended March 31, 2026, June 30, 2026 and September 30, 2026, which Merit filed with the SEC. Actual results will likely differ, and may differ materially, from anticipated results. ABOUT MERIT Founded in 1987, Merit Medical Systems, Inc. is engaged in the development, manufacture, and distribution of proprietary medical devices used in interventional, diagnostic, and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care, and endoscopy. Merit serves customers worldwide with a domestic and international sales force and clinical support team totaling approximately 900 individuals. Merit employs approximately 7,500 people worldwide. *ABOUT CiDA Controversies in Dialysis Access (CiDA) is a leading multidisciplinary educational forum dedicated to advancing the care of patients requiring dialysis access. Established in 2003, CiDA brings together vascular surgeons, interventional radiologists, nephrologists, and other healthcare professionals to examine current challenges, emerging technologies, clinical research, and evolving approaches to dialysis access management. Through expert presentations, interactive debates, case discussions, and hands-on education, CiDA promotes collaboration and the exchange of knowledge to improve patient care. For more information, visit www.dialysiscontroversies.org. TRADEMARKS Unless noted otherwise, trademarks and registered trademarks used in this release are the property of Merit Medical Systems, Inc., its subsidiaries, or its licensors. CONTACTSPR/Media InquiriesSarah ComstockMerit Medical+1-801-432-2864 | sarah.comstock@merit.com INVESTOR INQUIRIESMike Piccinino, CFA, IRCWestwicke – ICR+1-443-213-0509 | mike.piccinino@westwicke.com TLPP (primary effectiveness endpoint) was defined as the proportion of patients who did not require an intervention due to clinically driven target lesion revascularization or target lesion thrombosis.ACPP (a secondary effectiveness endpoint) was defined as the proportion of patients without loss of vascular access anywhere within the circuit from the time of their initial treatment to the need for reintervention or abandonment of vascular access.Gilbert et al. 2021. “First Clinical Results of the Merit WRAPSODY™ Cell-Impermeable Endoprosthesis for Treatment of Access Circuit Stenosis in Haemodialysis Patients.” Cardiovasc Interv Radiol 44, no. 12 (Dec): 1903–13. doi: 10.1007/s00270-021-02953-8.Razavi et al. 2025. “Six-Month Safety and Efficacy Outcomes from the Randomized-Controlled Arm of the WRAPSODY Arteriovenous Access Efficacy (WAVE) Trial.” Kidney Int 107, no. 4 (Apr): 740–50. doi: 10.1016/j.kint.2025.01.006.Razavi et al. 2026. “One-Year Clinical Outcomes from the Randomized-Controlled Arm of the WRAPSODY Arteriovenous Access Efficacy (WAVE) Trial.” J Vasc Interv Radiol 37, no. 6 (Jun): 108593. Online ahead of print. doi: 10.1016/j.jvir.2026.108593.Razavi et al. 2026. “Safety and Effectiveness of the Wrapsody Cell-Impermeable Endoprosthesis to Treat Dysfunctional Arteriovenous Grafts: Results from the Nonrandomized Arm of the WAVE Trial.” J Vasc Interv Radiol 37, no. 6 (Jun): 108594. Online ahead of print. doi: 10.1016/j.jvir.2026.108594.
510(k) Application to U.S. Food and Drug Administration and Application for European Union Certification Submitted in Fourth Quarter 2026NEW YORK, Nov. 05, 2026 (GLOBE NEWSWIRE) — Baird Medical Investment Holdings Limited (NASDAQ: BDMD) (“Baird Medical” or the “Company”), a global leader in microwave ablation (MWA) technology, today announced that its strategic partner, Tianjin Yuanshan Medical Technology Co., Ltd. (“Alpmed”), has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) and an application for CE conformity assessment in the European Union for an irreversible electroporation (IRE) system. The system is designed for soft tissue ablation, with the potential to be used to treat a range of tumor types, and is being advanced under the companies’ previously announced partnership. IRE is an advanced, minimally-invasive, non-thermal ablation technology that uses high-voltage electrical pulses to disrupt cell membranes and induce cell death. This mechanism may offer advantages when treating tissue near sensitive anatomical structures. Under the partnership with Alpmed, Baird Medical is leading global regulatory interactions during the respective review processes, and holds worldwide commercial rights for the IRE system. The companies are targeting potential U.S. FDA 510(k) clearance and EU CE marking in 2027, subject to the outcome of the respective regulatory review processes. “The U.S. 510(k) submission and EU CE conformity assessment application represent two significant milestones as we continue working to expand our portfolio of minimally-invasive ablation platforms beyond our core MWA technology. If cleared, adding IRE to our portfolio could create additional opportunities to address indications for which thermal ablation may not be the optimal solution,” said Haimei Wu, Chairwoman and CEO of Baird Medical. “That these submissions were completed less than three months after the signing of the cooperation agreement with Alpmed is a testament to the capabilities and commitment of our teams as well as the broader potential of this strategic partnership. We look forward to productive interactions with the regulators in the U.S. and EU during the respective review processes, and to providing updates on our progress, as appropriate.” About Baird Medical Baird Medical is a global, pioneering medical device company specializing in minimally invasive ablation technologies for a range of solid tumors. The Company’s lead product, a microwave ablation (MWA) system, is FDA-cleared for soft tissue ablation and is being launched in the U.S. primarily for the treatment of benign thyroid nodules. In addition, the Company is expanding its minimally invasive technology portfolio, including IRE-based products and an AI-powered robotic ablation system. Baird Medical’s MWA solutions have been adopted by a growing number of leading U.S. institutions and private practice groups, including the Mayo Clinic, Columbia University Medical Center, and The George Washington University Hospital. The company is rapidly expanding its global commercial footprint, with sales now reaching markets across multiple continents. About Alpmed Alpmed is a member company of Saixiang Group and is under common control with Tianjin Saixiang Technology Co., Ltd. (SZSE: 002337), a publicly listed company. Alpmed focuses on the research, development, and innovation of IRE technology and is an early mover and one of the leading companies in the field. The company has established an IRE technology portfolio across four areas: tumor ablation, cardiac electrophysiology, peripheral vascular intervention, and interventional pulmonology. In oncology, Alpmed has commercialized China’s first domestically developed IRE ablation product for malignant liver and pancreatic tumors. The company is also advancing applications of its technology in prostate, thyroid, breast, and other solid tumor indications. Forward-Looking Statements This press release includes certain statements that are not historical facts but 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 relate to future events or Baird Medical’s future financial or operating performance. In some cases, you can identify forward-looking statements by terminology such as “may”, “could”, “should”, “expect”, “intend”, “might”, “will”, “estimate”, “anticipate”, “believe”, “budget”, “forecast”, “intend”, “plan”, “potential”, “predict”, or “continue”, or the negatives of these terms or variations of them or similar terminology. Forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Baird Medical and its management, are inherently uncertain. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. You should not place undue reliance on forward-looking statements in this press release, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein. Baird Medical does not undertake any duty to update these forward-looking statements. Actual results may vary materially from those expressed or implied by forward-looking statements based on a number of factors, including, without limitation: (1) the risk that Baird Medical may not be successful in expanding its business in China or the United States; (2) changes in general economic conditions; (3) regulatory conditions and developments; (4) changes in applicable laws or regulations; (5) the nature, cost and outcome of pending and future litigation and other legal proceedings instituted against Baird Medical or others; and (6) other risks and uncertainties from time to time described in the Registration Statement relating to the Business Combination and the transition report, including those listed under the sections titled “Risk Factors” therein, and in ExcelFin’s other filings with the SEC. The foregoing list of factors is not exclusive. Additional information concerning certain of these, and other risk factors is contained in ExcelFin’s most recent filings with the SEC and in the Registration Statement described above filed by Baird Medical in connection with its business combination with ExcelFin. All subsequent written and oral forward-looking statements concerning Baird Medical, the business combination described herein, or other matters attributable to Baird Medical or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements above. Readers are cautioned not to place undue reliance upon any forward-looking statements, which speak only as of the date made. Baird Medical expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in its expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based. Contact: Lee RothBurns McClellan for Baird MedicalLroth@burnsmc.com
Milestone reflects a decade of clinical trust, customer adoption and collaboration. SAN FRANCISCO, Nov. 5, 2026 /PRNewswire/ — Murj, a cardiac device management software and services company, today announced that more than 1 million patients are actively managed on its platform, marking…
IRVINE, Calif.–(BUSINESS WIRE)–Edwards Lifesciences (NYSE: EW) today reported financial results for the quarter ended September 30, 2026. Q3 Financial Highlights Q3 sales grew 10.5% to $1.72 billion1, constant currency2 sales grew 11.2% Q3 TAVR sales grew 8.0% to $1.24 billion1, constant currency2 sales grew 8.8% Q3 TMTT sales grew 44.0% to $207 million1,3, constant currency2 sales grew 45.6%3 Q3 EPS of $0.531; adjusted2 EPS of $0.801 which grew 19% versus prior year 2026 Outlook Increasing t
Company’s first-of-a-kind intelligent imaging system aims to expand patient access, streamline high-quality cardiac care, and establish the foundation for future robotic interventions LOS GATOS, Calif., Nov. 4, 2026 /PRNewswire/ — Laza Medical, Inc., a Shifamed portfolio company…
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 […]
