– Data Further Advance Understanding of VASCEPA®/VAZKEPA® Potential Mechanism of Action and Utility as A Complementary Therapy for Residual Risk Reduction in Combination with Statins in Important Patient Sub-Categories –DUBLIN and BRIDGEWATER, N.J., March 31, 2025 (GLOBE NEWSWIRE) — Amarin Corporation plc (NASDAQ:AMRN) today highlighted key data presentations at ACC.25 showcasing the mechanistic activity of eicosapentaenoic acid (EPA) on lipoprotein(a) [Lp(a)]-enriched plasma and the effects of a glucagon-like peptide-1 (GLP-1) receptor agonist in combination with EPA on the expression of proteins in endothelial cells. “The data presented at ACC.25 continue to underscore the therapeutic value of icosapent ethyl (IPE) and EPA in potentially addressing known pathways of cardiovascular (CV) risk beyond LDL lowering for patients,” said R. Preston Mason, Ph.D., Brigham and Women’s Hospital. “While emerging therapeutic approaches are being explored to address residual CV risk, especially in patients with additional risk factors like obesity and elevated glucose levels, cardiovascular disease remains the world’s leading cause of death and we cannot afford to wait. High-risk patients must be treated now, using proven therapies that have consistently demonstrated their ability to reduce CV risk—on top of the standard of care, including statins. We already have effective treatments available, and it is imperative that we utilize them to reduce patients’ CV risk and save lives today. These learnings further advance understanding of how EPA and VASCEPA/VAZKEPA may be working to reduce CV events in at-risk patients.” The key findings are outlined below: More Rapid Oxidation of Lipoprotein(a) [Lp(a)]-enriched Plasma Compared to Small Dense- and Triglyceride-rich Lipoproteins is Limited by Eicosapentaenoic Acid (EPA) In this analysis, researchers analyzed rates of oxidation for Lp(a)-enriched plasma to other atherogenic particles, including enriched small dense LDL (sdLDL), LDL, or triglyceride (TG)-rich lipoproteins (VLDL) with and without the introduction of EPA at a pharmacologic concentration. An elevated Lp(a) level is known to increase CV risk. New data from this analysis show that EPA dose-dependently inhibited oxidation in all lipoproteins tested, especially Lp(a) enriched human plasma. This is an important finding as the potent inhibition of Lp(a) oxidation by EPA may contribute to the benefit observed in REDUCE-IT, including in those subjects with elevated Lp(a) levels as recently reported in this publication. Addition of Eicosapentaenoic Acid (EPA) to a GLP-1 Agonist Enhanced Expression of Detoxification Proteins in Endothelial Cells During Inflammation In Vitro In this mechanistic analysis, researchers evaluated the separate versus combined effects of EPA and GLP-1 receptor agonist liraglutide on expression of proteins in endothelial cells. We know there is clear evidence backing the benefits of EPA in reducing cardiovascular events in at-risk patients. However, with emerging therapeutic approaches to address residual cardiovascular risk there is added value in exploring the combination of proven therapies, in this case EPA and GLP-1 receptor agonist, with complementary or additive protective mechanisms that may potentially play a role in further reducing cardiovascular risk on top of the statin therapy. The combination of EPA and GLP-1 receptor agonist favorably modulated the expression of proteins associated with detoxifying reactive oxygen species under disease-like conditions. Recent Data Published in JAHA: REDUCE-IT Analysis Shows Clear VASCEPA/ VAZKEPA Outcomes Benefit in Patients with Well-Controlled LDL-C A recent post hoc analysis of REDUCE-IT was published in the Journal of the American Heart Association this past month evaluating the impact of icosapent ethyl on top of statin therapy in reducing cardiovascular events in at-risk patients with various baseline LDL-C levels, including those with well-controlled LDL-C (
Author: Ken Dropiewski
CorVista Health Presents New Data on Non-Invasive Point of Care Testing for Pulmonary Capillary Wedge Pressure (PCWP) Elevation Using Machine Learning
New data show the machine learning algorithms may be used to detect PCWP elevation, aiding in assessment of heart failure with preserved ejection fraction (HFpEF) and pulmonary hypertension (PH) subtypesData was analyzed from patients signals collected using the CorVista System®, the world’s first non-invasive point-of-care solution currently approved for evaluating the presence of coronary artery disease and PH BETHESDA, Md., March 31, 2025 (GLOBE NEWSWIRE) — CorVista Health today announced a poster presentation showcasing preliminary results of its machine learning-based algorithm for non-invasively estimating pulmonary capillary wedge pressure (PCWP) elevation – a key indicator of heart failure with preserved ejection fraction. The poster titled ‘Point-of-Care Testing for Pulmonary Capillary Wedge Pressure Elevation Using Machine Learning on Non-invasive Signals’ was presented at the American College of Cardiology’s Annual Scientific Session (ACC.25) in Chicago on March 30, 2025. Currently, PCWP is measured through an invasive right heart catheterization (iRHC) procedure that requires a cardiologist, pulmonologist or intensivist. The CorVista capture device collects non-invasive signals for 3.5 minutes in patients at rest, which could potentially provide an alternative to iRHC in certain patient populations. The data demonstrate how machine learning signal analysis of a symptomatic population may provide a robust, non-invasive alternative to measuring PCWP elevation, potentially making early detection of HFpEF and PH subtypes more accessible. Key findings presented in poster: The machine learning-based test achieved 0.92 ROC-AUC, 90% sensitivity, and 76% specificity when tested in 283 patients, showing strong diagnostic performance consistently across multiple subgroups defined by sex, BMI and age – both confirming and ruling out disease with a high degree of certainty.Univariate analysis identified 247 features within the collected signal features that differentiate subjects with PCWP > 18mmHg vs PCWP ≤ 18mmHg when measured via iRHC.Model has a positive likelihood ratio of 3.8 and negative likelihood ratio of 0.13, indicating that the test has a strong impact on post-test probability in both test-positive and test-negative cases.Model resulted in a diagnostic odd ratio of 29, indicating that a positive result was 29 times more likely to be observed in a patient with heart failure than a patient without. “Heart failure with preserved ejection fraction can be challenging to diagnose in part because its symptoms overlap with many other conditions and although echocardiography is an excellent modality for estimating left ventricular ejection fraction (EF), its sensitivity for diagnosing diastolic dysfunction is rather abysmal,” said Charles R. Bridges, M.D., Sc.D., Executive Vice President and Chief Scientific Officer, CorVista Health. “The new data provide preliminary results for the feasibility of our non-invasive machine learning-based test to detect elevated PCWP with a high level of accuracy. HFpEF represents over 50 percent of all cases of heart failure and has the highest morbidity and mortality. The underdiagnosis of HFpEF is arguably the largest unmet need in cardiovascular medicine today, representing approximately $25 billion in direct costs to the US healthcare system annually. Moreover, PH is also vastly underdiagnosed, and it is critically important to differentiate subtypes of pulmonary hypertension which have distinct often lifesaving guideline-directed treatments.” The exploration of a PCWP add-on to the CorVista System represents a major advancement in cardiology, with potential implications for early diagnosis, cost reduction, and broader access to cardiovascular care. The CorVista System Add-On for elevated PCWP discussed here is currently an investigational device limited by federal law (or United States) law to investigational use and is not available for commercial distribution. The system is designed to be deployed anywhere with an internet connection – addressing the unmet need in rural and underserved populations with limited access to traditional standard of care. About CorVista System® The CorVista System is a point-of -care digital health solution that detects multiple heart conditions in a single, non-invasive test. The system uses machine learned algorithms to quickly analyze heart signals and detect issues like blocked arteries or high pressure in the lungs—all in under 30 minutes, allowing clinicians to interpret results and guide treatment decisions in a single visit. The system received clearance from the U.S. Food and Drug Administration (FDA) for coronary artery disease in September 2023 and Pulmonary Hypertension in April 2024, with additional indications, including heart failure, in active development. In 2022, the CorVista System’s PH indication was awarded an FDA Breakthrough Device Designation—marking the first major advancement in PH diagnostics in over 40 years and setting a new standard for patient care. About CorVista Health CorVista Health is on a mission to transform cardiovascular care with diagnostics that shorten the path from symptoms to diagnosis, empowering earlier treatment and better patient outcomes. We are dedicated to enabling more equitable care by providing access to immediately actionable, high-quality cardiovascular test results for previously underserved patient populations – with the goal of contributing to a future where everyone has timely access to life-saving cardiovascular care. For more information on CorVista Health, please visit: www.corvista.com Media Contact:media@corvista.com
Maze Therapeutics Reports Fourth Quarter and Full-Year 2024 Financial Results and Recent Highlights
MZE829 Phase 2 HORIZON Trial Enrolling Patients with APOL1 Kidney Disease (AKD); Initial Data Expected in Q1 2026 MZE782 Phase 1 Healthy Volunteer Trial Ongoing; Initial Data Expected in H2 2025 Raised $140 Million in Gross Proceeds in Upsized IPO in February 2025, Providing Expected Cash Runway into H2 2027 SOUTH SAN FRANCISCO, Calif., March 31, 2025 (GLOBE NEWSWIRE) — Maze Therapeutics, Inc. (Nasdaq: MAZE), a clinical-stage biopharmaceutical company developing small molecule precision medicines for patients with renal, cardiovascular and metabolic diseases, today reported financial results for the fourth quarter and year ended December 31, 2024, highlighted recent progress and reiterated upcoming milestones. “Maze has reached a pivotal moment in our journey. On the heels of a successful IPO and with two ongoing clinical-stage programs – MZE829 for AKD and MZE782 for both chronic kidney disease (CKD) and phenylketonuria (PKU) – we are making meaningful progress towards advancing genetic-based medicines with the potential to transform patient care,” said Jason Coloma, Ph.D., chief executive officer of Maze. “We look forward to reporting initial Phase 1 data for MZE782 in healthy volunteers in the second half of 2025, which will enable us to prepare to initiate Phase 2 trials in CKD and PKU. We also expect to report initial data from the Phase 2 HORIZON trial of MZE829 in patients with AKD in the first quarter of next year. With a strong financial foundation, highly accomplished team and clear mission, we are well-positioned to execute our milestones and deliver breakthrough medicines to patients.” Pipeline Accomplishments and Upcoming Milestones MZE829 for AKD MZE829 is an oral, small molecule APOL1 inhibitor that Maze is advancing as a potential treatment for patients with AKD, a subset of CKD estimated to affect over one million people in the United States alone. In February 2025, Maze dosed the first patient in the Phase 2 HORIZON Study of MZE829 in patients with AKD. The trial is enrolling a broad population of AKD patients, including those with more severe disease who have nephrotic range proteinuria, focal segmental glomerulosclerosis (FSGS), patients with lower levels of proteinuria and hypertensive nephropathy and patients with proteinuria and diabetic kidney disease. Maze expects to announce topline data from the Phase 2 trial in the first quarter of 2026. In October 2024, Maze reported positive Phase 1 results for MZE829 in healthy volunteers, which demonstrated that MZE829 was well tolerated at single doses up to 480 mg and multiple doses up to 350 mg daily over seven days, with dose-proportional pharmacokinetics and low variability. The observed half-life of approximately 15 hours supports once-daily dosing of MZE829. MZE782 in CKD and PKU MZE782 is an oral small molecule targeting the solute transporter SLC6A19, with potential to be a first-in-class treatment for approximately five million U.S. patients with CKD who have inadequate responses to currently available CKD therapies, as well as those with PKU, an inherited metabolic disorder. In September 2024, Maze initiated a Phase 1 clinical trial of MZE782 in healthy volunteers. Maze expects to report initial data, including proof-of-mechanism biomarkers, in the second half of 2025. Based on Phase 1 results, Maze plans to initiate two parallel Phase 2 clinical trials of MZE782 in CKD and PKU. Corporate Highlights In February 2025, Maze completed an upsized IPO, raising approximately $140 million in gross proceeds, before deducting underwriting discounts and commissions and other offering expenses, through the sale of 8,750,000 shares at $16.00 per share. In November 2024, Maze closed an oversubscribed $115 million Series D financing co-led by Frazier Life Sciences and Deep Track Capital, with participation from Janus Henderson Investors and Logos Capital. Approximately $40 million of the $115 million represented the conversion of previously issued convertible notes held by existing investors. Combined gross proceeds of approximately $255 million from the two financings are expected to provide runway into the second half of 2027, supporting completion of Phase 2 clinical trials for MZE829 in AKD and MZE782 in CKD and PKU, as well as continued advancement of additional preclinical programs. Fourth Quarter and Full Year 2024 Financial Results Cash Position: Cash and cash equivalents were $196.8 million as of December 31, 2024, compared to $29.2 million as of December 31, 2023. Maze expects its current cash and cash equivalents, which includes proceeds from its February 2025 IPO, will fund operations into the second half of 2027. License Revenue: License revenue was $167.5 million for the year ended December 31, 2024, compared to none for the year ended December 31, 2023. The increase was primarily due to the receipt of a one-time upfront payment of $150.0 million in May 2024 under the license agreement with Shionogi & Co., Ltd. (Shionogi) for the development of MZE001 in Pompe disease. No license revenue was recognized for the fourth quarter of 2024 and 2023. Research & Development (R&D) Expenses: R&D expenses were $22.2 million for the fourth quarter of 2024 and $83.5 million for the year ended December 31, 2024, compared to $16.0 million for the fourth quarter of 2023 and $73.9 million for the year ended December 31, 2023. This year-over-year increase primarily reflects higher clinical trial expenses for MZE829 and MZE782 as well as for preclinical studies for MZE782. General & Administrative (G&A) Expenses: G&A expenses were $7.5 million for the fourth quarter of 2024 and $26.4 million for the year ended December 31, 2024, compared to $7.0 million for the fourth quarter of 2023 and $24.6 million for the year ended December 31, 2023. This year-over-year increase primarily reflects higher personnel-related expenses, including non-cash stock-based compensation expense, partially offset by lower expenses for professional services. Net (Loss) Income: Net loss was $29.6 million for the fourth quarter of 2024 and net income was $52.2 million for the year ended December 31, 2024, compared to net loss of $26.6 million for the fourth quarter of 2023 and net loss of $100.4 million for the year ended December 31, 2023. Net income for the year ended December 31, 2024 includes $167.5 million in license revenue recognized under various license agreements, including the exclusive license agreement with Shionogi. About Maze Therapeutics Maze Therapeutics is a clinical-stage biopharmaceutical company harnessing the power of human genetics to develop novel, small molecule precision medicines for patients living with renal, cardiovascular and related metabolic diseases, including obesity. The company is advancing a pipeline using its Compass platform, which provides insights into the genetic variants in disease and links them with the biological pathways that drive disease in specific patient groups. The company’s pipeline is led by two wholly owned lead programs, MZE829 and MZE782, each of which represents a novel precision medicine-based approach for patients. For more information, please visit mazetx.com, or follow us on LinkedIn and X. Forward Looking Statements This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect the current beliefs and expectations of management. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including, without limitation, statements concerning the company’s future plans and prospects, any expectations regarding the safety or efficacy of MZE829, MZE782 and other candidates under development, the ability of MZE829 to treat AKD or other indications, the ability of MZE782 to treat CKD, PKU or other indications, the planned timing of the company’s clinical trials, data results and further development of MZE829, MZE782 and other therapeutic candidates, and the sufficiency of the company’s cash and cash equivalents to fund its operating expenses and capital expenditure requirements. In addition, when or if used in this press release, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and similar expressions and their variants, as they relate to the company may identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Although the company believes the expectations reflected in such forward-looking statements are reasonable, the company can give no assurance that such expectations will prove to be correct. Readers are cautioned that actual results, levels of activity, safety, performance or events and circumstances could differ materially from those expressed or implied in the company’s forward-looking statements due to a variety of factors, including risks and uncertainties related to the company’s ability to advance MZE829, MZE782 and its other therapeutic candidates, obtain regulatory approval of and ultimately commercialize the company’s therapeutic candidates, the timing and results of preclinical studies and clinical trials, the company’s ability to fund development activities and achieve development goals, its ability to protect its intellectual property, general business and economic conditions, and risks related to the impact on its business of macroeconomic conditions, including inflation, volatile interest rates, tariffs, instability in the global banking sector, and public health crises. Further information on potential risk factors that could affect the company’s business and its financial results are detailed under the heading “Risk Factors” included in the company’s Annual Report on Form 10-K for the year ended December 31, 2024, filed with the U.S. Securities and Exchange Commission (SEC) on March 31, 2025, and the company’s annual and quarterly reports and other filings filed from time to time with the SEC. Accordingly, readers are cautioned not to place undue reliance on these forward-looking statements. These forward-looking statements speak only as of the date of this press release and Maze undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof. Corporate Contact:Jillian Connell, Maze Therapeuticsjconnell@mazetx.com(650) 850-5080 Media Contact:Dan Budwick, 1ABdan@1abmedia.com Maze Therapeutics, Inc. Select Condensed Financial Information (in thousands, except share and per share amounts) (unaudited) Condensed Statements of Operations Three months ended Year ended December 31, December 31, 2024 2023 2024 2023 License revenue$— $— $167,500 $— Operating expenses: Research and development 22,216 16,045 83,496 73,945 General and administrative 7,510 7,006 26,418 24,606 Total operating expenses 29,726 23,051 109,914 98,551 (Loss) income from operations (29,726) (23,051) 57,586 (98,551)Interest and other income, net 1,516 304 4,654 1,966 Change in fair value of convertible promissory notes (1,644) (3,830) (8,837) (3,830)(Loss) income before income tax expense$(29,854) $(26,577) $53,403 $(100,415)Income tax benefit (expense) 275 — (1,172) — Net (loss) income$(29,579) $(26,577) $52,231 $(100,415)Net (loss) income attributable to common stockholders, basic and diluted$(44,551) $(26,577) $3,405 $(100,415)Net (loss) income per share attributable to common stockholders: Basic$(18.32) $(11.46) $1.42 $(43.89)Diluted$(18.32) $(11.46) $1.25 $(43.89)Weighted-average shares used in computing net (loss) income per share attributable to common stockholders: Basic 2,431,764 2,318,137 2,396,094 2,287,980 Diluted 2,431,764 2,318,137 2,730,299 2,287,980 Condensed Balance Sheet Data December 31, December 31, 2024 2023 Cash and cash equivalents $196,812 $29,158 Total assets $240,542 $71,504 Total liabilities $43,638 $61,450 Total redeemable convertible preferred stock and stockholders’ deficit $196,904 $10,054
Anteris Technologies Reaches Clinical Milestone: 100 patients treated with DurAVR® THV
MINNEAPOLIS and BRISBANE, Australia, March 31, 2025 (GLOBE NEWSWIRE) — Anteris Technologies Global Corp. (Anteris® or the Company) (NASDAQ: AVR, ASX: AVR) a global structural heart company committed to designing, developing, and commercializing cutting-edge medical devices, announces a significant milestone in our mission to restore heart valve patients to healthy function. Our first in class, biomimetic DurAVR® Transcatheter Heart Valve (THV) has now been used to treat over 100 patients worldwide, marking a major achievement in our goal to revolutionize cardiac care in patients affected by severe aortic stenosis. Highlights: Over 100 patients successfully treated with the DurAVR® THV, including de novo (first time) aortic stenosis cases, valve-in-valve (ViV) patients and complex anatomies such as bicuspid aortic valve patients*65 patients have successfully completed the primary endpoint measures of safety and efficacy, including hemodynamic benefit at 30-days post implantOne-year efficacy data on 37 aortic stenosis patients continues to validate the exceptional hemodynamic performance, with sustained large effective orifice areas (EOAs) and low mean pressure gradients (MPGs)Excellent safety profile demonstrated at one-year, with no valve or cardiovascular related mortalityRange of valve sizes used to accommodate a broad patient population Anteris Chief Medical Officer, Chris Meduri, M.D., commented: “We are incredibly proud to have reached this milestone, which represents years of dedication, research, and importantly collaboration with expert physicians in the field. The excellent hemodynamic performance we are seeing is noteworthy in that it shows that DurAVR® has the potential to restore natural heart valve function and thereby redefine what success looks like in the treatment of aortic stenosis.” Dr. Michael Reardon, Allison Family Distinguished Chair of Cardiovascular Research and Professor of Cardiothoracic Surgery at the Houston Methodist Hospital and Study Chair of the DurAVR® THV Pivotal Trial said, “We are building on a strong foundation of clinical evidence, and we remain committed to rigorous scientific evaluation as we progress toward the all-risk, head-to-head, DurAVR® registration trial.” Vice Chairman and CEO, Wayne Paterson added, “This is a clinical milestone for the company and its investors. Not only have we crossed the threshold of having treated over 100 patients, but we have achieved results that are clinically relevant and significantly differentiated to current therapies. DurAVR® is the first new class of product in this space in many years and the current results across often complex patients confirms the value of the product for physicians and patients as we move into our registration trial this year.” The Company remains on track to commence the DurAVR® THV Pivotal Trial in the third quarter of 2025, pending U.S. Food and Drug Administration (“FDA”) approval. *A bicuspid aortic valve (BAV) is a congenital heart condition where the aortic valve, which regulates blood flow from the heart to the aorta, has only two leaflets (or flaps) instead of the normal three. About Anteris Anteris Technologies Global Corp. (NASDAQ: AVR, ASX: AVR) is a global structural heart company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function. Founded in Australia, with a significant presence in Minneapolis, USA, Anteris is a science-driven company with an experienced team of multidisciplinary professionals delivering restorative solutions to structural heart disease patients. Anteris’ lead product, the DurAVR® Transcatheter Heart Valve (THV), was designed in partnership with the world’s leading interventional cardiologists and cardiac surgeons to treat aortic stenosis – a potentially life-threatening condition resulting from the narrowing of the aortic valve. The balloon-expandable DurAVR® THV is the first biomimetic valve, which is shaped to mimic the performance of a healthy human aortic valve and aims to replicate normal aortic blood flow. DurAVR® THV is made using a single piece of molded ADAPT® tissue, Anteris’ patented anti-calcification tissue technology. ADAPT® tissue, which is FDA-cleared, has been used clinically for over 10 years and distributed for use in over 55,000 patients worldwide. The DurAVR® THV System is comprised of the DurAVR® valve, the ADAPT® tissue, and the balloon-expandable ComASUR® Delivery System. Forward-Looking Statements This announcement contains forward-looking statements. Forward-looking statements include all statements that are not historical facts. Forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “budget,” “target,” “aim,” “strategy,” “plan,” “guidance,” “outlook,” “intend,” “may,” “should,” “could,” “will,” “would,” “will be,” “will continue,” “will likely result” and similar expressions, although not all forward-looking statements contain these identifying words. These forward-looking statements are subject to a number of risks, uncertainties, and assumptions, including those described under “Risk Factors” in Anteris’ Annual Report on Form 10-K for the fiscal period ended December 31, 2024 that was filed with the SEC and ASX. Readers are cautioned not to put undue reliance on forward-looking statements, and except as required by law, neither ATL or Anteris assume any obligation to update any of these forward-looking statements to conform these statements to actual results or revised expectations. Authorisation and Additional information This announcement was authorised for release on the ASX by the Board of Directors. For more information: Investor Relationsinvestor@anteristech.comDebbie OrmsbyAnteris Technologies Global Corp.+61 1300 550 310 | +61 7 3152 3200Investor Relations (US)mchatterjee@bplifescience.comMalini Chatterjee, Ph.D.Blueprint Life Science Group+1 917 330 4269 Website www.anteristech.comX@AnterisTechLinkedInhttps://www.linkedin.com/company/anteristech
Lilly’s lepodisiran reduced levels of genetically inherited heart disease risk factor, lipoprotein(a), by nearly 94% from baseline at the highest tested dose in adults with elevated levels
In Phase 2 ALPACA results, lepodisiran significantly reduced levels of genetically inherited cardiovascular risk factor, with some patients sustaining reductions for nearly 1.5 years These data were presented at the American College of Cardiology 2025 Scientific Sessions and…
Medtronic Evolut™ TAVR system shows durable clinical outcomes and outstanding valve performance at five years in low-risk aortic stenosis patients
GALWAY, Ireland and CHICAGO, March 30, 2025 /PRNewswire/ — Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced late-breaking data on five-year outcomes from the Evolut Low Risk Trial. Data shows, versus surgery, the Evolut™ transcatheter aortic valve…
SCORE analysis of semaglutide 2.4 mg demonstrated reduction in cardiovascular events in a real-world setting
Building on results of the landmark SELECT trial, SCORE shows cardiovascular (CV) risk reduction with use of semaglutide 2.4 mg in a real-world environment1 SCORE is a retrospective, observational analysis of 27,963 patients with obesity or overweight and established cardiovascular…
Anthos Therapeutics Shares New Data from the Landmark AZALEA-TIMI 71 Study Demonstrating the Factor XI Inhibitor Abelacimab Significantly Reduced Bleeding in Patients Regardless of Age or Bleeding Risk
–Data presented at the American College of Cardiology Annual Scientific Session show that the reduction of bleeding with abelacimab compared to rivaroxaban (Xarelto) was even greater in patients ≥75 years old compared to younger patients –Another analysis from AZALEA-TIMI 71 shows abelacimab, as compared to rivaroxaban (Xarelto), was associated with a greater absolute benefit in patients who are at higher risk for bleeding CAMBRIDGE, Mass., March 29, 2025 (GLOBE NEWSWIRE) — Anthos Therapeutics, Inc., a transformative, clinical-stage biopharmaceutical company developing innovative therapies for the treatment of cardiovascular metabolic diseases, is presenting two new analyses from its landmark AZALEA-TIMI 71 study at the American College of Cardiology Annual Scientific Session (ACC.25) demonstrating the novel Factor XI inhibitor abelacimab significantly reduced bleeding in patients regardless of age or bleeding risk. These data will be presented today during the moderated poster sessions from 2:30-4:30pm CT. In the first analysis, the safety of abelacimab, a novel Factor XI inhibitor, was compared to rivaroxaban, a direct oral anticoagulant (DOAC), by patient age. Inhibition of Factor XI with abelacimab significantly reduced the relative risk of major or clinically relevant non-major (CRNM) bleeding compared with rivaroxaban regardless of age, with potential for greater absolute risk reduction (ARR) with older patients. The ARR in patients 75 years of age and older was 6.2% compared to 4.2% in patients less than 75 years. In addition, abelacimab consistently reduced bleeding risk in patients 75 years of age and older regardless of renal function, body mass index (BMI), and the use of concomitant antiplatelet therapy. “Patients with atrial fibrillation, particularly older patients, are frequently at a high risk of bleeding. There is a need for safer anticoagulants that can prevent thrombotic events while minimizing excess bleeding,” said Christian T. Ruff, MD, MPH, senior investigator of TIMI Group, director General Cardiology, Brigham and Women’s Hospital, and associate professor, Harvard Medical School. “These data show that abelacimab significantly reduced the risk of major or CRNM bleeding, particularly among people over 75 who are vulnerable to such risks, and, if approved, could be a safer alternative for patients needing anticoagulation therapy.” In the second analysis, the safety of abelacimab was compared to rivaroxaban across a spectrum of bleeding risk, which was determined by using the direct oral anticoagulant (DOAC) score, a clinical tool leveraged to assess the risk of bleeding in patients who are prescribed DOACs. In patients with atrial fibrillation, abelacimab reduced rates of bleeding relative to rivaroxaban regardless of bleeding risk, with greater absolute safety benefit in those at higher bleeding risk. In the rivaroxaban arm, the rates of major or CRNM bleeding per 100 patient years increased stepwise across risk categories from 5.6% in the low risk category to 21.2% in the very high risk category. In contrast, the rates of bleeding in patients in the pooled abelacimab arm were 2.5% in the low-risk category to 7.1% in the very high-risk category. The ARR increased from 3.1% in the low risk category to 14.1% in the very high risk category (p-trend for ARR
MiRus Siegel™ TAVR: First EFS Cases
ATLANTA, March 28, 2025 /PRNewswire/ — MiRus is pleased to announce the launch of the US multi-center Early Feasibility Study of the Siegel™ 8-Fr aortic transcatheter heart valve (THV). The first two cases were successfully performed this week by Pradeep K. Yadav MD, Director of…
LifeTech Scientific Corporation Announced 2024 Annual Results: Revenue Exceeded RMB1.3 billion, and International Business Increased by 26%
SHENZHEN, China, March 28, 2025 /PRNewswire/ — LifeTech Scientific Corporation (the “Company” or “LifeTech”, Stock code: 1302.HK), a company specializing in minimally invasive interventional medical devices for cardio-cerebrovascular and peripheral vascular diseases, together with its…