The Latest Cardiac and Vascular News
This focus issue examines the “diagnostic odyssey,” evolving risk stratification, and the use of AI tools to reveal patterns in infiltrative and inflammatory cardiomyopathies. WASHINGTON, May 14, 2026 /PRNewswire/ — Inflammatory and infiltrative cardiomyopathies remain among the most…
Orchestra BioMed targeting enrollment completion of BACKBEAT Global Pivotal Trial (“BACKBEAT Trial”) by the end of Q3 2026 Orchestra BioMed and Medtronic plc. (NYSE: MDT, “Medtronic”), the Company’s strategic collaborator for the BACKBEAT Trial, intend to submit primary endpoint results for consideration as a late-breaker at a major cardiology conference in Q2 2027Medtronic plans to submit AVIM Therapy-related marketing application for FDA approval after primary endpoint data analyses and reports are complete and pursue subsequent global regulatory approvals, assuming primary safety and efficacy endpoints are met NEW HOPE, Pa., May 12, 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 global medical device companies, today announced an update to the overall clinical and regulatory timeline for the BACKBEAT Trial evaluating Atrioventricular Interval Modulation Therapy (“AVIM Therapy”) in pacemaker-indicated patients with uncontrolled hypertension despite medications. The Company is targeting completion of enrollment by the end of the third quarter of 2026. Further, the Company and Medtronic, its strategic collaborator for the BACKBEAT Trial and the commercialization of AVIM Therapy for the treatment of uncontrolled hypertension in patients indicated for a pacemaker, plan to submit the primary endpoint data for a late-breaking clinical trial presentation at a major cardiovascular conference in the second quarter of 2027. Lastly, assuming primary safety and efficacy endpoints are met, Medtronic plans to submit a marketing application for FDA approval after primary endpoint data analyses and reports are complete, and subsequently to pursue global regulatory approvals. The updated BACKBEAT Trial timeline is supported by FDA approval of a reduction in the sample size for the clinical trial to a target total of 284 evaluable randomized subjects with the total enrollment target of 316 patients accounting for potential loss to follow up. The primary efficacy endpoint (between-group difference in 24-hour ambulatory systolic blood pressure “aSBP” at 3-month follow up) and primary safety endpoint (freedom from unanticipated serious adverse device events in the AVIM Therapy arm at 3-month follow up) remain robustly powered ( >90% statistical power) at the revised sample size for the trial. The sample size is designed to detect a between group difference of at least 5 mmHg in aSBP. The change in sample size reflects collaboration among Orchestra BioMed, Medtronic and the FDA under the Breakthrough Devices program, and follows FDA approval of an amendment to the BACKBEAT Trial protocol received on May 8, 2026 by Orchestra BioMed. David Hochman, Chairman, Chief Executive Officer of Orchestra BioMed, commented, “We are delighted to provide clarity on the anticipated overall timeline for the BACKBEAT Trial, which reflects ongoing global enrollment momentum and FDA alignment with a streamlined sample size that remains highly powered to assess AVIM Therapy’s efficacy and safety at the 3-month primary endpoints. We believe BACKBEAT has the potential to be a landmark pivotal trial that can open up an entirely new therapeutic modality for patients at increased risk from high blood pressure and hypertensive heart disease.” Robert C. Kowal, M.D., Ph.D., Vice President and General Manager for Cardiac Pacing Therapies in the Medtronic Cardiac Rhythm Management operating unit, stated, “For decades, cardiac pacing has been foundational in the management of rhythm disorders. With the BACKBEAT Trial, Medtronic and Orchestra BioMed are investigating whether AVIM Therapy can extend the benefits of pacing to the field of hypertension management in high-risk patients. This update reflects our shared confidence in progress toward the completion of enrollment, the submission of data to the FDA, and the presentation of clinical evidence.” 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 TherapyAVIM 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. MODERATO II, a double-blind, randomized pilot study, showed that patients treated with AVIM Therapy experienced net reductions of 8.1 mmHg in 24-hour ambulatory systolic blood pressure (aSBP) and 12.3 mmHg in office systolic blood pressure (oSBP) at six months when compared to control patients. 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 study 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 enrollment, 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, 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:Kelsey KirkOrchestra BioMedkkirkellis@orchestrabiomed.com
ISSUED ON BEHALF OF VENTRIPOINT DIAGNOSTICS LTD. USANewsGroup.com News Commentary VANCOUVER, BC, May 12, 2026 /PRNewswire/ — Cardiovascular disease is about to become the most expensive problem in American medicine. The American Heart Association fired a warning shot in late April: U.S….
SANTA CLARA, Calif.–(BUSINESS WIRE)–Johnson & Johnson Advances the Standard of Calcium Modification with Global Launch of Shockwave™ C2 Aero Coronary IVL Catheter
Multinational Real-world Data Reinforce Favorable Clinical Profile and Long-Term Safety SOUTH SAN FRANCISCO, Calif., May 11, 2026 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) today announced the presentation of new data reinforcing the clinical profile of MYQORZO® (aficamten) at the European Society of Cardiology (ESC) Heart Failure 2026 Congress. The presentations include new analyses from SEQUOIA-HCM, the pivotal Phase 3 clinical trial of aficamten in patients with oHCM; MAPLE-HCM, the Phase 3 clinical trial of aficamten compared to metoprolol in patients with symptomatic obstructive HCM (oHCM); and FOREST-HCM, the open-label extension trial of aficamten. Collectively, the new evidence expands understanding of the effectiveness of cardiac myosin inhibition with aficamten compared directly to metoprolol, a beta blocker, as well as specific safety and durability characteristics of MYQORZO across patient demographics, clinical, and economic subgroups. “The breadth of research being presented at ESC Heart Failure 2026 reflects our commitment to deepening the scientific understanding of oHCM and heart failure,” said Stephen Heitner, M.D., Senior Vice President, Clinical Research and Development, Cytokinetics. “These new insights underscore the strength and consistency of the clinical profile of MYQORZO, adding to the growing body of real-world evidence informing physician treatment decisions.” New Analyses Show MYQORZO Outperforms Metoprolol Across Sex and Doses A dose-dependent analysis from MAPLE-HCM compared aficamten to the beta-blocker metoprolol in patients with symptomatic oHCM. Key findings showed significant improvements in exercise capacity, outflow gradients, and N-terminal pro-B-type natriuretic peptide (NT-proBNP) across all treatment doses. Conversely, metoprolol failed to show improvement in these outcomes regardless of the dose administered (Figure 1). Figure 1 A secondary analysis of sex differences in MAPLE-HCM showed consistent benefits of MYQORZO in women. Despite women entering the trial (42%) with more severe baseline characteristics, MYQORZO delivered nearly identical improvements in peak oxygen consumption (pVO2) for both sexes (+2.2 mL/kg/min). Both groups also saw significant gains in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) and reductions in cardiac biomarkers and NT-proBNP. Long-term Data Reinforce Safety and Efficacy Profile of MYQORZO A prospective analysis of 122 patients who had interpretable ambulatory electrocardiogram (ECG) data at screening in the FOREST-HCM showed that long-term treatment with MYQORZO—up to 96 weeks—did not increase the incidence of arrhythmias in patients, including those who underwent withdrawal of beta-blocker therapy. Among 122 patients, the incidence of non-sustained ventricular tachycardia (NSVT) on ambulatory ECG remained stable through 96 weeks compared with baseline, with no increase in atrial fibrillation (AF) episodes and no newly identified subclinical AF. There was also no increase in arrhythmia frequency among a subgroup of 16 patients who discontinued beta-blocker therapy during aficamten treatment. These results represent the first prospective analysis of ambulatory ECG monitoring in patients treated with a cardiac myosin inhibitor and are consistent with the low incidence of clinically detected arrhythmias previously reported for patients with oHCM treated with aficamten. Additionally, an open-label extension study of aficamten in Chinese patients with symptomatic oHCM showed that aficamten was well tolerated using the same dosing strategy of individualized titration as was used globally. Through 48 weeks of treatment with aficamten, patients experienced no serious or severe treatment-emergent adverse events, no occurrences of LVEF
Results with next-generation cardiac myosin inhibitor suggest a potentially disease-modifying therapy in non-obstructive hypertrophic cardiomyopathy HRS/BHB-1893 treatment resulted in rapid and sustained reductions in key biomarkers, structural remodeling and meaningful improvements in…
-Acoramidis increased sTTR early and significantly reduced intra-individual sTTR variability versus placebo (p
Nataliya Agafonova
Nataliya Agafonova, M.D., Chief Medical Officer, Longeveron
Phase 2b clinical trial (ELPIS II) evaluating laromestrocel as a potential adjunct treatment for HLHS, a rare pediatric disease and orphan-designated indicationDMC performed a risk-benefit assessment, identified no new safety concerns, and recommended continuation of the study as designed through completionThis review represents the final planned independent safety assessment prior to completion of the trialELPIS II top-line trial results anticipated in August 2026 MIAMI, May 11, 2026 (GLOBE NEWSWIRE) — Longeveron Inc. (NASDAQ: LGVN), a clinical stage biotechnology company developing cellular therapy for life-threatening, rare pediatric and chronic aging-related conditions, today announced that the independent Data Monitoring Committee (DMC) has completed its final prespecified data review for the ongoing, fully enrolled, Phase 2b clinical trial (ELPIS II) evaluating laromestrocel (Lomecel-B®) as a potential adjunct therapy for hypoplastic left heart syndrome (HLHS). The DMC based its review on available data for all participating patients enrolled. The DMC performed a risk-benefit assessment, indicated no safety concerns, and approved the study to continue as designed to completion. “We are grateful to the members of the DMC for their effort and diligence in this review,” said Nataliya Agafonova, M.D., Chief Medical Officer at Longeveron. “Based on the scientific rationale supporting laromestrocel and the clinical data generated to date, we remain encouraged by the potential of our investigational therapy in HLHS. With our Phase 2b clinical trial for HLHS having achieved full enrollment last June, we continue to anticipate top-line trial results in August 2026 and look forward to sharing the data.” ELPIS II enrolled 40 pediatric patients at 12 leading pediatric cardiac centers across the country. The clinical trial is being conducted in collaboration with the National Heart, Lung, and Blood Institute (NHLBI) through grants from the National Institutes of Health (NIH). ELPIS II builds on findings from ELPIS I study, in which treated children demonstrated 100% transplant-free survival up to five years of age. Published historical outcomes in HLHS populations have reported substantial mortality despite surgical palliation. The U.S. Food and Drug Administration (FDA) has granted laromestrocel Orphan Drug designation, Fast Track designation, and Rare Pediatric Disease designation, for development for HLHS. About Hypoplastic Left Heart Syndrome (HLHS) HLHS is a rare congenital heart defect that effects approximately 1,000 infants per year in the U.S. Infants with HLHS are born with an underdeveloped left ventricle, which creates a life-threatening condition due to the heart’s inability to pump adequate amounts of blood throughout the body. The current treatment requires infants to undergo a complex three-stage heart reconstruction surgery process over the first five years of their life. Despite staged surgical palliation, long-term mortality and morbidity remain substantial, with progressive right ventricular dysfunction representing a major contributor to adverse outcomes. There is clearly an important unmet medical need to improve right ventricular function in these infants to positively impact both short- and long-term patient outcomes. About laromestrocel (Lomecel-B®)Laromestrocel is a living cell product made from specialized cells isolated from the bone marrow of young healthy adult donors. These specialized cells, known as mesenchymal stem cells (MSCs), are essential to our endogenous biological repair mechanism. MSCs have been shown to perform a number of complex functions in the body and support tissue repair and regenerative signaling pathways. They also have been shown to respond to sites of injury or disease and secrete bioactive factors that are immunomodulatory and regenerative. We believe that laromestrocel MSCs may have multiple potential mechanisms of action that may lead to anti-inflammatory, pro-vascular regenerative responses, and therefore may have broad application for a range of rare and aging related diseases. About Longeveron Inc. Longeveron is a clinical stage biotechnology company developing regenerative medicines to address unmet medical needs. The Company’s lead investigational product is laromestrocel (Lomecel-B™), an allogeneic mesenchymal stem cell (MSC) therapy product isolated from the bone marrow of young, healthy adult donors. Laromestrocel has multiple potential mechanisms of action encompassing pro-vascular, pro-regenerative, anti-inflammatory, and tissue repair and healing effects with broad potential applications across a spectrum of disease areas. Longeveron is pursuing four pipeline indications: hypoplastic left heart syndrome (HLHS), Alzheimer’s disease (AD), Pediatric Dilated Cardiomyopathy (DCM) and Aging-related Frailty. Laromestrocel development programs have received five distinct and important FDA designations: for the HLHS program – Orphan Drug designation, Fast Track designation, and Rare Pediatric Disease designation; and, for the AD program – Regenerative Medicine Advanced Therapy (RMAT) designation and Fast Track designation. For more information, visit www.longeveron.com or follow Longeveron on LinkedIn, X, and Instagram. Forward-Looking StatementsCertain statements in this press release that are not historical facts are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, which reflect management’s current expectations, assumptions, and estimates of future operations, performance and economic conditions, and involve known and unknown risks, uncertainties, and other important factors that could cause actual results, performance, or achievements to differ materially from those anticipated, expressed, or implied by the statements made herein. Forward-looking statements are generally identifiable by the use of forward-looking terminology such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expects,” “intend,” “looks to,” “may,” “on condition,” “plan,” “potential,” “predict,” “preliminary,” “project,” “see,” “should,” “target,” “will,” “would,” or the negative thereof or comparable terminology, or by discussion of strategy or goals or other future events, circumstances, or effects. Factors that could cause actual results to differ materially from those expressed or implied in any forward-looking statements in this release include, but are not limited to, our cash position and need to raise additional capital, the difficulties we may face in obtaining access to capital, and the dilutive impact it may have on our investors; our financial performance, and ability to continue as a going concern; the period over which we estimate our existing cash and cash equivalents will be sufficient to fund our future operating expenses and capital expenditure requirements; the ability of our clinical trials to demonstrate safety and efficacy of our product candidates, and other positive results; the timing and focus of our ongoing and future preclinical studies and clinical trials, and the reporting of data from those studies and trials; the size of the market opportunity for certain of our product candidates, including our estimates of the number of patients who suffer from the diseases we are targeting; our ability to scale production and commercialize the product candidate for certain indications; the success of competing therapies that are or may become available; the beneficial characteristics, safety, efficacy and therapeutic effects of our product candidates; our ability to obtain and maintain regulatory approval of our product candidates in the U.S. and other jurisdictions; our plans relating to the further development of our product candidates, including additional disease states or indications we may pursue; our plans and ability to obtain or protect intellectual property rights, including extensions of existing patent terms where available and our ability to avoid infringing the intellectual property rights of others; the need to hire additional personnel and our ability to attract and retain such personnel; and our estimates regarding expenses, future revenue, capital requirements and needs for additional financing. Further information relating to factors that may impact the Company’s results and forward-looking statements are disclosed in the Company’s filings with the Securities and Exchange Commission, including Longeveron’s Annual Report on Form 10-K for the year ended December 31, 2024, filed with the Securities and Exchange Commission on February 28, 2025, its Quarterly Reports on Form 10-Q, and its Current Reports on Form 8-K. The Company operates in highly competitive and rapidly changing environment; therefore, new factors may arise, and it is not possible for the Company’s management to predict all such factors that may arise nor assess the impact of such factors or the extent to which any individual factor or combination thereof, may cause results to differ materially from those contained in any forward-looking statements. The forward-looking statements contained in this press release are made as of the date of this press release based on information available as of the date of this press release, are inherently uncertain, and the Company disclaims any intention or obligation, other than imposed by law, to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. Investor and Media Contact:Derek ColeInvestor Relations Advisory Solutionsderek.cole@iradvisory.com A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/e9e96d9c-d6c3-4aec-ba85-36631b520211
Six-month clinical data from 40 patients highlights safety, effective decongestion, stable renal function, and reduced rehospitalizations using the eLym™ System Six-month clinical data from 40 patients highlights safety, effective decongestion, stable renal function, and reduced rehospitalizations using the eLym™ System
New site highlights clinical evidence and streamlined access to the Vivio® System for outpatient HF diagnosis PASADENA, Calif., May 7, 2026 /PRNewswire/ — Ventric Health, maker of the Vivio® System, the only FDA-cleared non-invasive device for measuring elevated left ventricular…
