The Latest Cardiac and Vascular News
Approval marks a historic milestone for Americans living with ssAR who are at high risk for surgery and previously had no dedicated transcatheter treatment option Approval marks a historic milestone for Americans living with ssAR who are at high risk for surgery and previously had no dedicated transcatheter treatment option
SAN FRANCISCO, March 16, 2026 /PRNewswire/ — Allelica, a leader in genomic risk assessment for common diseases, announced today that polygenic risk scores (PRS) have been recognized as a risk-enhancing factor in the 2026 American College of Cardiology (ACC) and American Heart Association…
DUBLIN and BRIDGEWATER, N.J., March 16, 2026 (GLOBE NEWSWIRE) — Amarin Corporation plc (NASDAQ: AMRN), a company committed to advancing the science of cardiovascular disease (CVD) worldwide, today announced that additional REDUCE-IT patient subgroup analysis and additional mechanistic data on potential multifactorial biologic activities will be presented at the American College of Cardiology’s Annual Scientific Session & Expo, March 28-30, 2026, in New Orleans, LA. Featured Amarin-supported abstracts to be presented by academic collaborators (italicized below) at ACC Scientific Sessions 2026 include: Oral Presentation Efficacy of Icosapent Ethyl Among Patients at Extreme Cardiovascular Risk: A Secondary Analysis of REDUCE-ITRahul Aggarwal, Deepak L. Bhatt, Michael Miller, Eliot A. Brinton, Terry A. Jacobson, Steven Ketchum, Hakima Hannachi, Armando Lira Pineda, Jean Claude Tardif, Christie M. Ballantyne, Philippe Gabriel Steg– Available March 29th, 12:30pm CST– Highlighted Original Research Stage, Posters, Hall E Poster Presentation Rates of Lipoprotein(a) Oxidation Increase at Elevated Levels in Non-linear Fashion and Inhibited by Eicosapentaenoic Acid (EPA)Samuel CR. Sherratt, Peter Libby, Deepak Bhatt, R. Preston Mason– Available March 28th, 11:00 am CST– Posters, Hall E About AmarinAmarin is a global pharmaceutical company committed to reducing the cardiovascular disease (CVD) burden for patients and communities and to advancing the science of cardiovascular care around the world. We own and support a global branded product approved by multiple regulatory authorities based on a track record of proven efficacy and safety and backed by robust clinical trial evidence. Our commercialization model includes a direct sales approach in the U.S. and an indirect distribution strategy internationally, through a syndicate of reputable and well-established partners with significant geographic expertise, covering close to 100 markets worldwide. Our success is driven by a dedicated, talented, and highly skilled team of experts passionate about the fight against the world’s leading cause of death, CVD. About REDUCE-IT®REDUCE-IT was a global cardiovascular outcomes study designed to evaluate the effect of VASCEPA in adult patients with LDL-C controlled to between 41-100 mg/dL (median baseline 75 mg/dL) by statin therapy and various cardiovascular risk factors including persistent elevated triglycerides between 135-499 mg/dL (median baseline 216 mg/dL) and either established cardiovascular disease (secondary prevention cohort) or diabetes mellitus and at least one other cardiovascular risk factor (primary prevention cohort). REDUCE-IT, conducted over seven years and completed in 2018, followed 8,179 patients at over 400 clinical sites in 11 countries with the largest number of sites located within the United States. REDUCE-IT was conducted based on a special protocol assessment agreement with FDA. The design of the REDUCE-IT study was published in March 2017 in Clinical Cardiology.i The primary results of REDUCE-IT were published in The New England Journal of Medicine in November 2018ii. The total events results of REDUCE-IT were published in the Journal of the American College of Cardiology in March 2019.iii These and other publications can be found in the R&D section on the company’s website at www.amarincorp.com. About Cardiovascular RiskCardiovascular disease is the number one cause of death in the world. In the United States alone, cardiovascular disease results in 859,000 deaths per year.iv And the number of deaths in the United States attributed to cardiovascular disease continues to rise. In addition, in the United States there are 605,000 new and 200,000 recurrent heart attacks per year (approximately 1 every 40 seconds). Stroke rates are 795,000 per year (approximately 1 every 40 seconds), accounting for 1 of every 19 U.S. deaths. In aggregate, in the United States alone, there are more than 2.4 million major adverse cardiovascular events per year from cardiovascular disease or, on average, 1 every 13 seconds. Controlling bad cholesterol, also known as LDL-C, is one way to reduce a patient’s risk for cardiovascular events, such as heart attack, stroke or death. However, even with the achievement of target LDL-C levels, millions of patients still have significant and persistent risk of cardiovascular events, especially those patients with elevated triglycerides. Statin therapy has been shown to control LDL-C, thereby reducing the risk of cardiovascular events by 25-35%.v Significant cardiovascular risk remains after statin therapy. People with elevated triglycerides have 35% more cardiovascular events compared to people with normal (in range) triglycerides taking statins.vi,vii,viii About VASCEPA®/VAZKEPA® (icosapent ethyl) Capsules VASCEPA capsules are the first prescription treatment approved by the U.S. Food and Drug Administration (FDA) comprised solely of the active ingredient, icosapent ethyl (IPE), a unique form of eicosapentaenoic acid. VASCEPA was launched in the United States in January 2020 as the first drug approved by the U.S. FDA for treatment of the studied high-risk patients with persistent cardiovascular risk despite being on statin therapy. VASCEPA was initially launched in the United States in 2013 based on the drug’s initial FDA approved indication for use as an adjunct therapy to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. Since launch, VASCEPA has been prescribed more than twenty-five million times. VASCEPA is covered by most major medical insurance plans. In addition to the United States, VASCEPA is approved and sold in Canada, China, Australia, Lebanon, the United Arab Emirates, Saudi Arabia, Qatar, Bahrain, and Kuwait. In Europe, in March 2021 marketing authorization was granted to icosapent ethyl in the European Union for the reduction of risk of cardiovascular events in patients at high cardiovascular risk, under the brand name VAZKEPA. In April 2021 marketing authorization for VAZKEPA was granted in Great Britain (applying to England, Scotland and Wales). VAZKEPA is currently approved and sold in Europe in Sweden, Finland, England/Wales, Spain, Netherlands, Scotland, Greece, Portugal, Italy, Denmark and Austria. United States Indications and Limitation of Use VASCEPA is indicated: As an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels (≥ 150 mg/dL) and established cardiovascular disease or diabetes mellitus and two or more additional risk factors for cardiovascular disease.As an adjunct to diet to reduce TG levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia. The effect of VASCEPA on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined. Important Safety Information VASCEPA is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to VASCEPA or any of its components. VASCEPA was associated with an increased risk (3% vs 2%) of atrial fibrillation or atrial flutter requiring hospitalization in a double-blind, placebo-controlled trial. The incidence of atrial fibrillation was greater in patients with a previous history of atrial fibrillation or atrial flutter.It is not known whether patients with allergies to fish and/or shellfish are at an increased risk of an allergic reaction to VASCEPA. Patients with such allergies should discontinue VASCEPA if any reactions occur.VASCEPA was associated with an increased risk (12% vs 10%) of bleeding in a double-blind, placebo-controlled trial. The incidence of bleeding was greater in patients receiving concomitant antithrombotic medications, such as aspirin, clopidogrel or warfarin.Common adverse reactions in the cardiovascular outcomes trial (incidence ≥3% and ≥1% more frequent than placebo): musculoskeletal pain (4% vs 3%), peripheral edema (7% vs 5%), constipation (5% vs 4%), gout (4% vs 3%), and atrial fibrillation (5% vs 4%).Common adverse reactions in the hypertriglyceridemia trials (incidence >1% more frequent than placebo): arthralgia (2% vs 1%) and oropharyngeal pain (1% vs 0.3%).Adverse events may be reported by calling 1-855-VASCEPA or the FDA at 1-800-FDA-1088.Patients receiving VASCEPA and concomitant anticoagulants and/or anti-platelet agents should be monitored for bleeding. FULL U.S. FDA-APPROVED VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT WWW.VASCEPA.COM EuropeFor further information about the Summary of Product Characteristics (SmPC) for VAZKEPA® in Europe, please visit: https://www.ema.europa.eu/en/documents/product-information/vazkepa-epar-product-information_en.pdf Globally, prescribing information varies; refer to the individual country product label for complete information. Forward-Looking Statements This press release contains forward-looking statements which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including beliefs about Amarin’s outlook for achievements in 2026 and beyond; Amarin’s 2026 financial outlook and cash position; Amarin’s overall efforts to expand access and reimbursement to VAZKEPA across global markets; expectations regarding potential strategic collaboration and licensing agreements with third parties, including our ability to attract additional collaborators, as well as our plans and strategies for entering into potential strategic collaboration and licensing agreements and the overall potential and future success of VASCEPA/VAZKEPA and Amarin that are based on the beliefs and assumptions and information currently available to Amarin. All statements other than statements of historical fact contained in this press release are forward-looking statements. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. A further list and description of these risks, uncertainties and other risks associated with an investment in Amarin can be found in Amarin’s filings with the U.S. Securities and Exchange Commission, including Amarin’s annual report on Form 10-K for the fiscal year ended 2025. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date they are made. Amarin undertakes no obligation to update or revise the information contained in its forward-looking statements, whether as a result of new information, future events or circumstances or otherwise. Amarin’s forward-looking statements do not reflect the potential impact of significant transactions the company may enter into, such as mergers, acquisitions, dispositions, joint ventures or any material agreements that Amarin may enter into, amend or terminate. Investors and others should note that Amarin communicates with its investors and the public using the company website (www.amarincorp.com), the investor relations website (www.amarincorp.com/investor-relations), including but not limited to investor presentations and investor FAQs, U.S. Securities and Exchange Commission filings, press releases, public conference calls and webcasts. Amarin Contact Information Media Inquiries: Tegan Berry Amarin Corporation plc PR@amarincorp.com Investor Inquiries: Devin Sullivan & Conor Rodriguez The Equity Group on Behalf of Amarindevin.sullivan.ext@amarincorp.com or conor.rodriguez.ext@amarincorp.comInvestor.relations@amarincorp.com _____________________________________________i Bhatt DL, Steg PG, Brinton E, et al., on behalf of the REDUCE-IT Investigators. Rationale and Design of REDUCE‐IT: Reduction of Cardiovascular Events with Icosapent Ethyl–Intervention Trial. Clin Cardiol. 2017;40:138-148.ii Bhatt DL, Steg PG, Miller M, et al., on behalf of the REDUCE-IT Investigators. Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia. N Engl J Med. 2019;380:11-22.iii Bhatt DL, Steg PG, Miller M, et al., on behalf of the REDUCE-IT Investigators. Effects of Icosapent Ethyl on Total Ischemic Events: From REDUCE-IT. J Am Coll Cardiol. 2019;73:2791-2802.iv American Heart Association. Heart Disease and Stroke Statistics—2020 Update: A Report From the American Heart Association. Circulation. 2020;141:e139-e596.v Ganda OP, Bhatt DL, Mason RP, et al. Unmet need for adjunctive dyslipidemia therapy in hypertriglyceridemia management. J Am Coll Cardiol. 2018;72(3):330-343.vi Budoff M. Triglycerides and triglyceride-rich lipoproteins in the causal pathway of cardiovascular disease. Am J Cardiol. 2016;118:138-145.vii Toth PP, Granowitz C, Hull M, et al. High triglycerides are associated with increased cardiovascular events, medical costs, and resource use: A real-world administrative claims analysis of statin-treated patients with high residual cardiovascular risk. J Am Heart Assoc. 2018;7(15):e008740.viii Nordestgaard BG. Triglyceride-rich lipoproteins and atherosclerotic cardiovascular disease – New insights from epidemiology, genetics, and biology. Circ Res. 2016;118:547-563
Heartflow PCI Navigator is the only integrated, AI-driven PCI planning tool that gives interventional cardiologists a patient-specific 3D model detailing anatomy, plaque composition, and lesion-specific physiology, all aligned to optimize potential stent placement.
Three presentations at ACC reinforce Heartflow’s AI-powered technology predicts MACE, drives superior lipid outcomes and results in cost-effective care First patient enrolled in pioneering NAVIGATE-PCI Registry assessing impact of Heartflow PCI Navigator on clinical strategy, efficiency and physician confidence across 5,000 patients MOUNTAIN VIEW, Calif., March 16, 2026 (GLOBE NEWSWIRE) — Heartflow, Inc. (Heartflow) (Nasdaq: HTFL), the leader in AI technology for coronary artery disease (CAD), today announced new clinical evidence and a landmark registry launch that together advance the company’s vision of transforming CAD management across every stage of the patient journey. At the American College of Cardiology (ACC) Annual Scientific Session, Heartflow is presenting new clinical evidence that further establishes AI-powered Heartflow Plaque Analysis as the leading tool for identifying high-risk patients earlier and guiding more effective medical management. Simultaneously, Heartflow has enrolled the first patient in the NAVIGATE-PCI Registry, the first large-scale effort to evaluate the real-world impact of CT-guided percutaneous coronary intervention (PCI) planning on clinical strategy, procedural efficiency and physician confidence. The registry is evaluating how often treatment plans change when physicians use the AI-driven insights provided by Heartflow PCI Navigator compared to angiography alone. “These milestones reflect tremendous progress toward Heartflow’s goal of transforming coronary artery disease from the world’s leading cause of death into a condition that can be detected early, diagnosed accurately, and managed for life,” said Campbell Rogers, M.D., F.A.C.C., Chief Medical Officer at Heartflow. “The Heartflow Plaque Analysis data presented at ACC and the launch of the NAVIGATE-PCI Registry represent important steps in building the rigorous real-world evidence needed to support AI-driven decision-making across the full continuum of cardiovascular care. From identifying high-risk patients earlier and improving how they are managed to generating the evidence needed to guide more precise interventions when required, Heartflow is giving physicians deeper insights and greater confidence so they can deliver better outcomes for patients.” Heartflow Plaque Analysis: New Clinical Evidence for Earlier Risk Stratification and Management Heartflow Plaque Analysis will be featured in three ACC 2026 presentations, covering long-term validation of risk stratification, real-world comparative effectiveness in lipid management, and economic sustainability. Collectively, these data reinforce Plaque Analysis as a personalized, clinically actionable and cost-effective solution for CAD management. AI-Based Coronary Plaque Analysis and Adverse Cardiovascular Events: The Mass General Brigham CCTA Registry (Poster 1082-09, March 29, 10:06 a.m. CDT)This cohort, based on a large-scale registry tracking over 15,000 patients, with up to 16 years of follow-up, demonstrated that Plaque Analysis is a powerful predictor of major adverse cardiovascular events (MACE), even after accounting for traditional risk factors and the severity of coronary stenosis. The findings reveal that patients with extensive plaque volume face a fourfold higher risk of such events. This robust, real-world data solidifies Heartflow Plaque Staging as the most powerful CTA-based independent predictor for personalized risk stratification, enabling clinicians to identify high-risk individuals beyond conventional metrics. “Stenosis has long been our primary lens for evaluating coronary risk, but it tells an incomplete story, as this registry demonstrates. With over 15,000 patients and 16 years of follow-up, we now have compelling real-world evidence that total plaque volume independently drives adverse events, regardless of risk factors or the presence of anatomical stenosis,” said Ron Blankstein, M.D., Director of Cardiac Computed Tomography at Brigham and Women’s Hospital, and Professor of Medicine and Radiology at Harvard Medical School. “These findings catalyze a meaningful shift in how we approach risk stratification by more accurately identifying patients who might otherwise have been characterized as having lower risk based on conventional assessment and optimizing management based on their actual disease burden.” Comparative Effectiveness of Coronary Computed Tomographic Angiography With or Without AI-Plaque Analysis and Stress Testing on Lipid Lowering After One Year: A Primary Analysis of the DECIDE Registry (Poster 1469-058, March 29, 12:30 p.m. CDT)This analysis, involving nearly 3,800 patients, compared patient management guided by CCTA with Plaque Analysis versus traditional stress-test-guided care over a one-year follow-up. A significantly higher portion of patients whose care was informed by Plaque Analysis initiated lipid-lowering therapy and achieved guideline-recommended LDL goals (
The Human Vascular System Stretches Up to 100,000 Miles — Standard Imaging Captures Only a Fraction of ItThe Endothelial Glycocalyx: A Microscopic Lining That Helps Regulate How Blood Moves Through the Smallest VesselsHow Patented Microfluidic Chip Technology Allows Researchers to Study Vascular Function Under Realistic ConditionsWhat This Means for the Millions of People Searching for Answers About Circulation, Energy, and Whole-Body Vitality A closer look at how microcirculation research is expanding what we understand about blood flow, oxygen delivery, and why the body’s smallest vessels may matter more than the largest ones Scottsdale, AZ, March 13, 2026 (GLOBE NEWSWIRE) — Calroy Health Sciences, a science-driven dietary supplement company focused on foundational vascular health, has published a comprehensive educational resource on microcirculation, blood flow, and the endothelial glycocalyx — the micro-thin, gel-like lining that coats the inside of every blood vessel in the body. The resource explores why this recently discovered structure is foundational to vascular health and total-body vitality, and why standard medical imaging often cannot assess the very network where oxygen and nutrient delivery actually occurs. The cardiovascular system is frequently visualized as a network of major arteries and veins — the primary conduits that transport blood to and from the heart. While these large vessels are essential for systemic circulation, they represent a small chapter of a much larger biological story. The vast majority of the vascular network is composed of microscopic vessels so narrow that red blood cells must travel single file to pass through them. This is the microcirculation — the capillary-level system where oxygen and nutrients are delivered directly to tissue. Standard medical imaging tools, including CT scans and angiograms, are designed to evaluate the body’s primary supply routes. They can confirm that the main conduits are open and functioning. However, these tools lose resolution long before they reach the capillary beds where the final exchange between blood and tissue actually occurs. “I often use a tree analogy,” explains Dr. Joel Kahn, MD, known as “America’s Holistic Heart Doc” and best-selling author and integrative cardiologist at the Kahn Center for Cardiac Longevity in Bingham Farms, Michigan, and a frequent educator for Calroy Health Sciences.. “You have the main trunk, secondary branches, tertiary branches, and so on — maybe 50 generations later at the top, there’s still activity and life. The arterial system works the same way. We can image the main trunk and maybe three or four generations of branches, but we’re really limited in imaging the microcirculation — that 10th, 40th, 50th generation of vessels.” This technological limitation means it is entirely possible for someone to pass a standard vascular screening with clear results while still experiencing fatigue, cold extremities, or mental fog — signals that may reflect what is happening at the microvascular level, not the arterial level. Lining the interior of every blood vessel in the body is a delicate, gel-like structure known as the endothelial glycocalyx (EGX). Only recently discovered and often overlooked, this micro-thin lining is foundational to vascular health and total-body vitality. It performs critical functions: it acts as a semi-permeable barrier, it facilitates smooth blood flow, and it houses the enzymes involved in the production of nitric oxide — the molecule, first identified in Nobel Prize–winning research, that signals blood vessels to relax and support healthy circulation. “There’s a single layer of cells — the endothelium — that separates the blood inside a blood vessel from the artery wall structure,” notes Dr. Kahn. “It’s almost like a Spanish-style tile floor of interlocking cells. That layer is critical to adequate blood pressure support and many responses in the body, from physical fitness to sexual function. You need a healthy endothelium. The glycocalyx sits on top of the endothelium, which consists of hair-like, protein-sugar structures resembling cake frosting. It’s very dynamic. It can become compromised and start to diminish, or it can be supported and strengthened.” When the glycocalyx is supported, it helps maintain the slippery-smooth quality of the vessel interior — facilitating the efficient transit of red blood cells through capillaries and supporting nutrient and oxygen delivery at the tissue level. Peer-reviewed research has examined specific markers of vascular elasticity and endothelial integrity that may be associated with this structure’s function. For decades, vascular research relied on static testing environments — observing cells in a stationary petri dish. While informative, this approach could not capture the dynamic behavior of the EGX under the physical shear stress of flowing blood. Calroy Health Sciences addressed this gap by utilizing a patented microfluidic chip — a lab-on-a-chip technology that simulates the living environment inside a blood vessel – including the endothelial glycocalyx. Instead of testing compounds in a motionless setting, researchers can observe the endothelial glycocalyx in a dynamic state, under conditions that more closely mirror what happens inside the human body. Through this approach, Calroy identified Monostroma nitidum, a rare marine algae containing the sulfated polysaccharide Rhamnan sulfate. A patented extract of this compound, trademarked as MonitumRS®, became the core of Arterosil HP® — a dietary supplement specifically formulated to support the integrity of the endothelial glycocalyx.* MonitumRS is scientifically shown to protect and restore the endothelial glycocalyx.*† Millions of people turn to search engines and AI tools every month asking about blood flow and circulation. In most cases, they are not looking for a clinical label — they are trying to make sense of the subtle shifts they experience throughout the day: afternoon energy dips, cold fingers and toes, or thinking that feels less sharp than it used to. The language people use — “How do I support circulation?” — is often a description of microvascular function. The experience of “flow” is frequently the experience of capillary efficiency, governed by the very structure that standard imaging cannot see. As vascular research continues to advance, the endothelial glycocalyx is emerging as a foundational area of focus for understanding how the body delivers oxygen and nutrients to every organ, every day. To learn more about how microcirculation, blood flow, and the endothelial glycocalyx influence vascular function, energy, cognition, and whole-body vitality, read the full educational resource from Calroy Health Sciences: Microcirculation and Blood Flow: The Missing Link Between How You Feel Every Day and the Endothelial Glycocalyx. FREQUENTLY ASKED QUESTIONSWhat is microcirculation and why does it matter? Microcirculation refers to the network of microscopic blood vessels — capillaries, arterioles, and venules — where the body’s actual exchange of oxygen and nutrients at the tissue level takes place. While the heart and major arteries are responsible for bulk transport, it is the microcirculation that determines whether oxygen and nutrients reach their final destination. The human vascular system stretches approximately 60-100,000 miles, and the vast majority of that distance exists at the capillary level. Supporting healthy microcirculation is foundational to whole-body vitality, including energy, cognition, and vascular well-being.* Every organ and system in the body from the brain, to sexual organs, to the joints rely on healthy microcirculation to function.* Calroy Health Sciences has published a comprehensive educational resource on this topic at calroy.com/education/microcirculation-and-blood-flow/. What is the endothelial glycocalyx? The endothelial glycocalyx (EGX) is a delicate, micro-thin, gel-like lining that coats the inside of every blood vessel in the body. Only recently discovered and often overlooked, it is foundational to vascular health and total-body vitality. The EGX acts as a semi-permeable barrier, facilitates smooth blood flow, and houses the enzymes involved in nitric oxide production — the molecule that helps blood vessels relax and support healthy circulation. When the glycocalyx is strong and healthy, circulation is supported and every organ feels the impact. Why do standard heart health screenings sometimes miss what people actually feel? Standard imaging tools like CT scans and angiograms are designed to evaluate large vessels — the body’s primary supply routes. They can confirm that the main conduits are open. However, they lose resolution before reaching the capillary beds where the actual exchange between blood and tissue occurs. This means it is possible to receive clear results from a standard vascular screening while still experiencing everyday shifts like fatigue, cold extremities, mental fog, or changes in sexual wellness — signals that may relate to microvascular function rather than large-vessel mechanics. How does Calroy Health Sciences study vascular function differently? Calroy utilizes a patented microfluidic chip — a lab-on-a-chip technology that simulates the living environment inside a blood vessel. Unlike static testing methods, this approach replicates the physical shear stress of flowing blood, allowing researchers to observe the endothelial glycocalyx in a dynamic state. Through this technology, Calroy identified and validated MonitumRS® (Rhamnan sulfate from Monostroma nitidum), the proprietary extract at the core of Arterosil HP® with MonitumRS®, which is specifically formulated to support the integrity of the endothelial glycocalyx.* Calroy’s published research is available in peer-reviewed journals. What is MonitumRS® and how is it different from other vascular support ingredients? MonitumRS® is a proprietary extract of Rhamnan sulfate derived from Monostroma nitidum, a rare marine algae. It is the core ingredient in Arterosil HP® with MonitumRS®. What distinguishes it is that it works. In the microfluidic chip study, it repaired the glucose-damaged endothelial glycocalyx cells up 103.8% from baseline in just 24 hours.*† †As demonstrated in an independent third-party laboratory in vitro study. Does circulation affect brain function and cognition? The brain is one of the body’s most oxygen-dependent organs. It relies on continuous, efficient blood flow to support cognitive function, mental clarity, and focus throughout the day. Because the brain’s oxygen supply depends on the microvascular delivery network — not just the major arteries — the health of the microcirculation and the endothelial glycocalyx are foundational to cognitive well-being. Supporting healthy circulation means supporting the system that delivers oxygen and nutrients to the brain at the tissue level. What is nitric oxide and what role does it play in circulation? Nitric oxide (NO) is a tiny molecule naturally produced by the body that plays a central role in the cardiovascular system. First identified in Nobel Prize–winning research, it helps blood vessels relax and widen, supporting healthy circulation and helping maintain healthy blood pressure already in the normal range.* The endothelial glycocalyx houses the enzymes responsible for nitric oxide production, making the health of this microscopic lining essential to the body’s ability to maintain vascular tone and flexibility. PUBLISHED RESEARCH & RESOURCES Research on the Endothelial Glycocalyx — Practitioner ResourcesResearch on Rhamnan Sulfate from Monostroma Nitidum — Practitioner ResourcesResearch on Nitric Oxide and the Vascular System — Practitioner ResourcesMarkers of Vascular Elasticity and Endothelial Integrity — PubMedCalroy’s Published Research — Calroy Health SciencesCalroy’s Patents — Calroy Health SciencesScience and Medical Advisory Board — Calroy Health Sciences About Calroy Health Sciences Calroy Health Sciences is a science-driven dietary supplement company dedicated to supporting foundational health. Co-founded by CEO Ed Hoyt and Chief Scientific Officer Chen Chen, PhD, Calroy brings more than three decades of combined experience in the dietary supplement industry. The company’s breakthrough products — Arterosil HP® with MonitumRS®, Vascanox HP® with Noxa24®, and Cartigenix HP® with RestorCel™ — are developed through a research-first approach that includes studying the finished formulated product, not just individual ingredients. Calroy’s research has been published in peer-reviewed journals and is conducted in partnership with major academic institutions, leading clinicians and researchers. The company also holds patents on its products and its microfluidic chip testing technology. For more information, visit calroy.com. SME Available for Commentary: Joel Kahn, MD — Integrative Cardiologist, Kahn Center for Cardiac Longevity *These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease. CONTACT: Sarah Evans
Partner, Head of PR, Zen Media
sarah@zenmedia.com
Segment showcases SynCardia Total Artificial Heart supporting patients with advanced heart failure and next-generation development programs Segment showcases SynCardia Total Artificial Heart supporting patients with advanced heart failure and next-generation development programs
Nearly 9 out of 10 patients achieved meaningful health benefit in 3-year pooled analysis Additionally, pooled analysis shows radiofrequency RDN cuts hypertensive emergencies by nearly half, saving potentially $199 million per year in related healthcare costs SPYRAL CARE to expand evidence for radiofrequency RDN in real-world Medicare patients March 10, […]
BOULDER, Colo., March 10, 2026 /PRNewswire/ — The American Journal of Preventive Cardiology (AJPC) announces the publication of the POLY-ACS trial investigating the effectiveness of a polypill strategy, combining multiple evidence-based therapies into a single daily formulation,…
WASHINGTON, March 10, 2026 (GLOBE NEWSWIRE) — Egg Medical, a leader in enhanced radiation protection devices (ERPD), today announced the results of a Late-Breaking Trial presented at the Cardiovascular Research Technologies (CRT) 2026 conference. The study, presented by Santiago Garcia, MD, of The Christ Hospital, confirms that the addition of the EggNest™ system reduces levels of scatter radiation to all members of the interventional team to the extent that users could do procedures safely without the use of lead aprons or wear ultralight aprons. “For decades, the interventional community has accepted a trade-off: protect your long-term health from the effects of radiation exposure by wearing heavy lead aprons at the cost of damaging your back and joints,” said Santiago Garcia, MD, the study’s lead presenter. “This data proves that we no longer must choose. By using the EggNest system, we can provide the entire team with protection that is superior to the status quo, by either going apron-free, or while wearing aprons that feel like a light vest. This is about ensuring that the next generation can have healthy careers without the physical toll.” The Key Study Findings: Annualized collar dose (in mrem) over lead aprons is 25.5 for the primary operator, 9.8 for assistant, and 10.2 for the nurse. When combined with ultralight aprons, total annualized body doses dropped to 1.41 for primary operator, 2.1 for assistant and 1.0 for the nurse.At these levels, a clinician would have to work for an entire career to receive the same radiation dose they currently receive in just one year under the standard of care.The study confirmed that whether clinicians choose to go apron-free, or wear aprons that are 55% lighter than standard lead, the entire team remained below traditional exposure levels using traditional methods. Modern labs are not one-size-fits-all. Under the banner of “Protection Is Personal,” the company is championing a responsible approach that allows clinicians to choose whether they want to go apron free. “Our goal is to give clinicians a choice—but one backed by rigorous, published data,” said Gavin Philipps, Chief Commercial Officer. “Choice isn’t a weakness; it’s how responsible safety programs operate. By providing personalized data through live dosimetry, the EggNest supports apron-free or ultralight apron workflows where approved, rather than forcing a specific behavior.” A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/548c258c-72cd-4a18-a8cb-e5066a8688cc CONTACT: Contact:
Susan Storm
sstorm@eggmedical.com
– The FDA assigned a PDUFA target action date of December 22, 2026 – – The NDA is based on positive data from a successful clinical program demonstrating favorable safety and blood pressure reduction in adults with hypertension – – Topline results from the Phase 2 Explore-OSA exploratory trial did not reduce AHI; demonstrated a clinically meaningful reduction in blood pressure and favorable safety and tolerability in this population with difficult to control hypertension – RADNOR, Pa., March 09, 2026 (GLOBE NEWSWIRE) — Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone, announced today that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for lorundrostat for the treatment of adult patients with hypertension in combination with other antihypertensive drugs. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of December 22, 2026. “The FDA’s acceptance of our NDA for lorundrostat marks an important milestone in our efforts to address the clinically significant need faced by millions of patients living with uncontrolled or resistant hypertension,” said Jon Congleton, Chief Executive Officer of Mineralys Therapeutics. “While the Explore-OSA trial did not demonstrate a reduction in AHI, the blood pressure reductions and safety profile were clinically meaningful, especially for this difficult to control population. We believe lorundrostat has the potential to become an important new treatment option for resistant and uncontrolled hypertension, and we look forward to working with the FDA as we advance toward potential approval.” Explore-OSA Trial Topline Results The Explore-OSA trial was a Phase 2 exploratory trial of lorundrostat in forty-eight participants with an average body mass index (BMI) of 38.2 kg/m2, an average apnea-hypopnea index (AHI) of 48.5 events/hr and an average systolic blood pressure (BP) of 142.3 mmHg (range 131-175 mmHg). After four weeks of treatment, lorundrostat 50 mg dosed in the evening did not demonstrate a clinically meaningful difference relative to placebo on the apnea-hypopnea index (AHI), the primary endpoint. At week four, the trial demonstrated an 11.1 mmHg (p < 0.0001) and a 1.0 mmHg (p = NS) BP reduction with lorundrostat and placebo, respectively, in the pre-planned parallel arm analysis of the first period. There was a 6.2 mmHg placebo-adjusted reduction (p < 0.0003) in BP in the crossover analysis. Lorundrostat demonstrated a favorable safety profile and was well tolerated, with no serum potassium excursions above 5.5 mmol/L. Analysis is ongoing for other endpoints in the trial and will be reported in future publications or medical meetings. About Launch-HTN Launch-HTN (NCT06153693) was a global, randomized Phase 3 double-blind, placebo-controlled trial of adults whose blood pressure (BP) remained uncontrolled despite being on two to five antihypertensive medications. Participants were assigned to one of three groups: placebo; lorundrostat 50 mg once daily; or lorundrostat 50 mg once daily with the option to increase to 100 mg at week six. The primary endpoint was change from baseline in systolic BP at six weeks versus placebo, measured by automated office blood pressure monitoring. About Advance-HTN Advance-HTN (NCT05769608) was a randomized, double-blind, placebo-controlled Phase 2 clinical trial that evaluated the efficacy and safety of lorundrostat for the treatment of uncontrolled or resistant hypertension, when used as an add-on therapy to a standardized background treatment of two or three antihypertensive medications in adult participants. Participants who met screening criteria had their existing hypertension medications discontinued and started on a standard regimen of an angiotensin II receptor blocker (ARB) and a diuretic, if previously on two medications, or a standard regimen of ARB, diuretic and calcium channel blocker if previously on three to five medications. Participants who remained hypertensive despite the standardized regimen were then randomized into three cohorts and treated for twelve weeks: lorundrostat 50 mg once daily, lorundrostat 50 mg once daily and an option to titrate to 100 mg once daily at week four based on defined criteria, or placebo. The trial’s primary endpoint was the change in 24-hour ambulatory systolic blood pressure at week twelve from baseline for active cohorts versus placebo. About Explore-OSA The Explore-OSA trial (NCT06785454) was a Phase 2 randomized, double-blind, placebo-controlled, crossover trial. This proof-of-concept trial was designed to evaluate the efficacy, safety, and tolerability of lorundrostat in overweight or obese adults with moderate-to-severe OSA and hypertension. Participants in Explore-OSA received 50 mg of oral, once daily (QD) lorundrostat and placebo in sequential treatment periods, with continuous monitoring of BP during overnight polysomnography. The primary efficacy endpoint of the trial was absolute change from baseline in apnea-hypopnea index (AHI) after four weeks of active treatment compared to placebo. The first secondary endpoint was AOBP, and additional endpoints were nighttime BP and sleep and cardiovascular health measures. About Obstructive Sleep Apnea OSA is characterized by repetitive overnight hypoxic episodes and subsequent sleep fragmentation due to a complete or partial collapse of the upper airway. Moderate to severe OSA is associated with increased production of aldosterone and increased nighttime BP; standard treatment with positive airway pressure is not sufficient for BP reduction. OSA impacts almost one billion people globally, including 425 million moderate-to-severe cases. Around 80% of adults with OSA are undiagnosed. As of 2025, untreated OSA is estimated to cost the United States more than $150 billion annually when considering direct medical expenses, productivity losses and accident-related costs. Between 30-50% of adults with hypertension have OSA, and this number increases to between 70-80% in adults with resistant hypertension (rHTN). Additionally, untreated moderate-to-severe OSA increases the risk of rHTN. Along with hypertension, OSA is a major risk factor of cardiovascular disease, type-2 diabetes mellitus and stroke. About Hypertension Having sustained, elevated blood pressure (BP or hypertension) increases the risk of heart disease, heart attack and stroke, which are leading causes of death in the United States. In 2022, more than 685,000 deaths in the United States included hypertension as a primary or contributing cause. Hypertension and related health issues resulted in an estimated annual economic burden of about $219 billion in the United States in 2019. Less than 50% of hypertension patients achieve their BP goal with currently available medications. Dysregulated aldosterone levels are a key factor in driving hypertension in approximately 30% of all hypertensive patients. About Lorundrostat Lorundrostat is a proprietary, orally administered, highly selective aldosterone synthase inhibitor being developed for the treatment of uncontrolled hypertension (uHTN) or resistant hypertension (rHTN), as well as CKD and OSA. Lorundrostat was designed to reduce aldosterone levels by inhibiting CYP11B2, the enzyme responsible for its production. Lorundrostat has 374-fold selectivity for aldosterone-synthase inhibition versus cortisol-synthase inhibition in vitro, an observed half-life of 10-12 hours and demonstrated a 40-70% reduction in plasma aldosterone concentration in hypertensive participants. The Company has now completed five successful Phase 2/3 clinical trials of lorundrostat supporting the efficacy and safety profile while also validating aldosterone as an integral therapeutic target in uHTN and rHTN. This includes two pivotal, registrational trials, including the Phase 3 Launch-HTN trial and Phase 2 Advance-HTN trial, which support the robust, durable and clinically meaningful reductions in systolic BP by lorundrostat. Lorundrostat was well tolerated in both trials with a favorable safety profile. About Mineralys Mineralys Therapeutics is a biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as CKD, OSA and other diseases driven by dysregulated aldosterone. Its initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor. Mineralys is based in Radnor, Pennsylvania, and was founded by Catalys Pacific. For more information, please visit https://mineralystx.com. Follow Mineralys on LinkedIn, Twitter and Bluesky. Forward Looking Statements Mineralys Therapeutics cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include, but are not limited to, statements regarding: the potential therapeutic benefits of lorundrostat; the timing and results of review of additional endpoints evaluated in the Explore-OSA clinical trial; the anticipated timing of the FDA’s review of the Company’s accepted NDA and any subsequent regulatory approval of lorundrostat; and the planned future clinical development of lorundrostat and the timing thereof; Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: topline results that we report are based on a preliminary analysis of key efficacy and safety data, and such data may change following a more comprehensive review of the data related to the clinical trial and such topline data may not accurately reflect the complete results of a clinical trial; any delays in the FDA’s review of our accepted NDA, including as a result of a government shutdown or reductions in agency funding or personnel, the results of our clinical trials, including the Advance-HTN and Launch-HTN trials, may not be deemed sufficient by the FDA to serve as the basis for regulatory approval of lorundrostat; later developments with the FDA may be inconsistent with the feedback from prior meetings, including whether the proposed pivotal program will support registration of lorundrostat following submission of an NDA and the FDA’s review of the same; our future performance is dependent entirely on the success of lorundrostat; potential delays in the commencement, enrollment and completion of clinical trials and nonclinical studies;; our dependence on third parties in connection with manufacturing, research and clinical and nonclinical testing; unexpected adverse side effects or inadequate efficacy of lorundrostat that may limit its development, regulatory approval and/or commercialization; unfavorable results from clinical trials and nonclinical studies; results of prior clinical trials and studies of lorundrostat are not necessarily predictive of future results; macroeconomic trends and uncertainty with regard to high interest rates, elevated inflation, tariffs and other trade policies, and the potential for a local and/or global economic recession; our ability to maintain undisrupted business operations due to any pandemic or future public health concerns; regulatory developments in the United States and foreign countries; our reliance on our exclusive license with Tanabe Pharma Corporation to provide us with intellectual property rights to develop and commercialize lorundrostat; and other risks described in our filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in our annual report on Form 10-K, and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Contact:Investor Relationsinvestorrelations@mineralystx.com Media RelationsMelyssa WeibleElixir Health Public RelationsEmail: mweible@elixirhealthpr.com
