The Latest Cardiac and Vascular News
CLEVELAND, June 13, 2025 /PRNewswire/ — Primary Investigator, Bernardo Cortese MD, proudly announces the successful completion of patient enrollment in the TRANSFORM II randomized controlled trial (RCT). This pivotal study aims to evaluate the safety and efficacy of the MagicTouch…
Proceeds will be used to grow the commercial organization, scale-up manufacturing operations, and launch additional products in the R&D pipeline. [San Diego, CA – June 10, 2025] Atraverse Medical, a medical device company pioneering next-generation transseptal access technology, today announced the close of a $29.4 million follow-on financing to accelerate […]
CHICAGO–(BUSINESS WIRE)–Cardio Diagnostics Holdings Inc. (Nasdaq: CDIO), an artificial intelligence-powered precision cardiovascular medicine company, today announced that the Japan Patent Office has issued a patent for another set of biomarkers in the company’s intellectual property portfolio. The patent, titled “Compositions and Methods for Detecting Predisposition to Cardiovascular Disease,” (Japanese Patent No. 7672192) is […]
KIRKLAND, Wash.–(BUSINESS WIRE)–Prevencio, Inc., the leader in artificial intelligence-powered blood tests for cardiovascular disease, today announced that it has been granted patents for its HART CADhs® test in the United States—marking the second U.S. patent for this novel test—as well as the European Union and Japan. These patents protect Prevencio’s […]
Novo Nordisk to present data from STEP UP trial on a higher dose of Wegovy® (semaglutide 7.2 mg) for those in need of greater weight loss Data will expand semaglutide evidence in both a clinical and real-world setting, including cardiometabolic and kidney health benefits for those with obesity and diabetesNovo Nordisk continues to pioneer obesity innovation, including presentation of full Phase 3 REDEFINE 1 and 2 trial results, providing insights into the transformational potential of CagriSema Bagsværd, Denmark, 10 June – Novo Nordisk today announced that new data from its industry-leading portfolio in metabolic and cardiovascular health will be showcased at the upcoming American Diabetes Association (ADA) 85th Scientific Sessions taking place in Chicago US, 20 – 23 June 2025. A total of 29 abstracts will be presented, including trials investigating the weight loss efficacy of higher dose Wegovy® (semaglutide 7.2 mg) in people with obesity (STEP UP) and those with obesity and type 2 diabetes (STEP UP T2D) as a new option for those in need of greater weight loss. New data will offer additional evidence of the broader cardiovascular and kidney health benefits of semaglutide for people with type 2 diabetes through analyses of the SOUL, STRIDE and FLOW trials, as well as insights from further real-world studies of semaglutide 2.4 mg. The presentation of the CagriSema REDEFINE 1 and 2 trials are the first ever Phase 3 data presented on a GLP-1 and amylin receptor agonist combination, offering insights into the transformational potential of this investigational medicine. Data will also be presented on pipeline candidate amycretin, demonstrating Novo Nordisk’s commitment to obesity innovation and individualised healthcare solutions. On 22 June, Novo Nordisk will also host an R&D investor event on their metabolic and cardiovascular health portfolio to cover the science and abstracts presented at the congress. The event will be accessible via a live webcast on the Novo Nordisk investor website. “Aiming to address individual needs and preferences for better health, we look forward to providing a higher dose of Wegovy® (semaglutide 7.2 mg) for people with obesity in need of more significant weight loss, alongside the broader health benefits seen with semaglutide,“ said Ludovic Helfgott, executive vice president of Product & Portfolio Strategy at Novo Nordisk. “Semaglutide has shown comprehensive and disease-modifying effects across the metabolic and cardiovascular health spectrum, and the data presented at ADA 2025 for Wegovy®, Rybelsus®, and Ozempic® will add to this evidence base as we aspire to a future where semaglutide is a foundational therapy that can provide people with comprehensive protection, early enough to make a difference.” “We recognise the complex interplay between cardiovascular and metabolic diseases, including type 2 diabetes and obesity, which require a personalised treatment approach,” said Martin Holst Lange, executive vice president for Development at Novo Nordisk. “As we look to further build an impactful portfolio of medicines to address patient needs, our data presented at ADA 2025 demonstrates not only how we are already delivering for a wide range of these needs with semaglutide, but that we are continuing to invest in innovation to support people living with serious chronic disease.” Novo Nordisk data overview at ADA 2025: ADA Scientific Sessions: Diabetes and peripheral artery disease—evolving role of GLP-1 RA and new insights from the STRIDE trial – Saturday 21 June; 13:30–15:00 CDTEfficacy and Safety of CagriSema 2.4 mg/2.4 mg in Adults with Overweight/Obesity—The REDEFINE 1 and REDEFINE 2 clinical trials – Sunday 22 June; 8:00–9:30 CDTSOUL trial—effects of oral semaglutide on cardiovascular (and other) outcomes in people with type 2 diabetes at high CV risk – Sunday 22 June; 16:30–18:00 CDT Novo Nordisk poster and oral presentations: Ozempic® (once-weekly semaglutide 1.0 mg) Impact of semaglutide on kidney, cardiovascular, and mortality outcomes by baseline BMI and weight loss in people with T2D and CKD: data from the FLOW Trial. Poster presentation (1971-LB poster) – Sunday 22 June; 12:30–13:30 CDTOnce-weekly semaglutide versus placebo for the treatment of type 2 diabetes and chronic kidney disease in Denmark: a long-term cost effectiveness analysis based on FLOW. Poster presentation (782-P) – Sunday 22 June; 12:30–13:30 CDTChanges in clinical measures in US adults with type 2 diabetes (T2D) and chronic kidney disease (CKD) who received once-weekly (OW) semaglutide. Poster presentation (838-P) – Sunday 22 June; 12:30–13:30 CDTChanges in clinical measures among US adults with type 2 diabetes (T2D) and chronic kidney disease (CKD) receiving once-weekly semaglutide (sema OW) vs. oral antidiabetic medications (ADMs). Poster presentation (2005-LB poster) – Sunday 22 June; 12:30–13:30 CDTEffect of type 2 diabetes characteristics on semaglutide treatment in people with type 2 diabetes and peripheral artery disease: a post-hoc analysis of the STRIDE Trial. Oral presentation (291-OR) – Monday 23 June; 13:30–13:45 CDT Rybelsus® (once-daily oral semaglutide) Real-world impact of oral semaglutide (sema) alone and vs DPP-4is on weight, BMI and HbA1c outcomes in type 2 diabetes (T2D): an observational study (PAUSE). Poster presentation (732-P) – Sunday 22 June; 12:30–13:30 CDTOral semaglutide and cardiovascular outcomes by baseline A1c and BMI in people with type 2 diabetes in the SOUL trial. Oral presentation (292-OR) – Monday 23 June; 13:45–14:00 CDT Wegovy® (once-weekly semaglutide 2.4 mg) Demographic and clinical characteristics associated with real-world persistence on semaglutide for weight management in the USA. Poster presentation (786-P) – Sunday 22 June; 12:30–13:30 CDTTwo-year real-world effectiveness of semaglutide in patients with obesity or overweight. Poster presentation (1733-P) – Monday 23 June; 12:30–13:30 CDTReduction of the 10-Year ASCVD risk in patients with overweight or obesity treated with semaglutide 2.4 mg in routine clinical care: a real-world study. Poster presentation (1734-P) – Monday 23 June; 12:30–13:30 CDT Once-weekly semaglutide 7.2 mg Efficacy and safety of semaglutide 7.2 mg in obesity: STEP UP trial. Poster presentation (1966-LB ePoster) – Saturday 21 June; 13:30–15:00 CDT Efficacy and safety of semaglutide 7.2 mg in obesity: STEP UP trial. Poster presentation (1966-LB poster) – Sunday 22 June; 12:30–13:30 CDT Efficacy and safety of semaglutide 7.2 mg in obesity and type 2 diabetes: STEP UP T2D trial. Poster presentation (1978-LB poster) – Sunday 22 June; 12:30–13:30 CDT CagriSema Effect of combined therapy with once-weekly subcutaneous cagrilintide 2.4 mg and semaglutide 2.4 mg (CagriSema) on energy intake, gastric emptying, and appetite in adults with overweight or obesity. Poster presentation (1969-LB poster) – Sunday 22 June; 12:30–13:30 CDTDiabetes, cagrisema-induced weight loss in diet-induced obese rats relies on preserved mitochondrial leak respiration in skeletal muscle. Poster presentation (1693-P) – Monday 23 June; 12:30–13:30 CDT Amycretin/amylin The amylin receptor selective agonist NN1213 reduces food intake and body weight in rats without decreasing calcium plasma levels. Oral presentation (86-OR) – Friday 20 June; 14:45–15:00 CDTAmycretin, a novel, unimolecular GLP-1 and amylin receptor agonist: results of a phase 1b/2a clinical trial. Poster presentation (2002-LB poster) – Sunday 22 June; 12:30–13:30 CDT Once-weekly insulin icodec Efficacy and hypoglycemia outcomes with once-weekly insulin icodec vs once-daily basal insulin in T2D by diabetes duration: ONWARDS 1–5. Poster presentation (816-P) – Saturday 21 June; 12:30– 13:30 CDTEfficacy and hypoglycemia outcomes with once-weekly insulin icodec vs once-daily basal insulin in T2D by baseline A1C: ONWARDS 1–5. Poster presentation (822-P) – Saturday 21 June; 12:30–13:30 CDTEfficacy and hypoglycemia outcomes with once-weekly insulin icodec vs once-daily basal insulin in T2D by baseline BMI: ONWARDS 1–5. Poster presentation (819-P) – Saturday 21 June; 12:30–13:30 CDT Once-weekly IcoSema CGM-derived model-based postprandial glucose with IcoSema vs other insulin regimens: a post hoc analysis of COMBINE 1 and 3. Poster presentation (815-P) – Saturday 21 June; 12:30–13:30 CDTA1C and hypoglycemia outcomes with once-weekly IcoSema vs comparators in T2D by kidney function. Poster presentation (804-P) – Saturday 21 June; 12:30–13:30 CDTCGM-based outcomes in adults with T2D receiving IcoSema vs comparators: post hoc analysis of COMBINE 1 and 3. Poster presentation (830-P) – Saturday 21 June; 12:30–13:30 CDTComparison of characteristics among individuals with established vs newly diagnosed type 2 diabetes during ischemic stroke hospitalization – a retrospective cohort study. Poster presentation (1373-P) – Saturday 21 June; 12:30–13:30 CDT Digital Health Effect of telemonitoring using connected devices on insulin injection adherence in people living with T2D. Oral presentation (315-OR) – Monday 23 June; 13:30–13:45 CDTTracking treatment outcomes using the semaglutide patient support solution app. Poster presentation (1098-P) – Sunday 22 June; 12:30–13:30 CDT General diabetes Prevalence and factors for treatment failure with sodium-glucose co-transporter 2 inhibitor (SGLT2i) in US adults with type 2 diabetes (T2D). Poster presentation (909-P) – Sunday 22 June; 12:30–13:30 CDTMacrovascular and microvascular complications in Medicare patients with type 2 diabetes and atherosclerotic cardiovascular disease from 2006-2021: incidence stratified by sex, age, and race/ethnicity. Poster presentation (1870-LB poster) – Sunday 22 June; 12:30–13:30 CDTElevated body mass index at type 2 diabetes diagnosis is associated with increased risk of cardiovascular disease and kidney outcomes. Poster presentation (427-P) – Monday 23 June; 12:30–13:30 CDT General obesity Health utilities of people with obesity in Taiwan: a nationwide representative analysis. Publication Only (63-PUB) About semaglutideSemaglutide is a glucagon-like peptide 1 receptor agonist (GLP-1 RA), which mimics the effects of the naturally occurring hormone GLP-1. Semaglutide has been tested in several robust clinical development programmes and outcome studies in cardiometabolic diseases, including type 2 diabetes, obesity, cardiovascular disease, heart failure, chronic kidney disease, liver disease and other related cardiometabolic diseases. It has a cumulative exposure of over 33 million patient-years since 2018.1 Semaglutide is marketed under the brand names Wegovy® (once-weekly semaglutide 2.4 mg injection), Ozempic® (once-weekly semaglutide 1.0 mg injection), and Rybelsus® (once-daily oral semaglutide 14 mg). About CagriSemaOnce-weekly subcutaneous CagriSema is being investigated by Novo Nordisk as a treatment for adults with overweight or obesity (REDEFINE programme) and as a treatment for adults with type 2 diabetes (REIMAGINE programme). CagriSema is a fixed-dose combination of a long-acting amylin analogue, cagrilintide 2.4 mg and semaglutide 2.4 mg. The two molecules induce weight loss by reducing hunger, increasing feelings of fullness, thereby helping people eat less and reduce their calorie intake. About amycretinAmycretin is a unimolecular long-acting GLP-1 and amylin receptor agonist under development by Novo Nordisk, to provide an efficacious and convenient treatment for adults with overweight or obesity and as a treatment for adults with type 2 diabetes. Amycretin is developed for oral and subcutaneous administration. About once-weekly basal insulin icodec Insulin icodec is a once-weekly basal insulin analogue designed to cover the basal insulin requirements for a full week with a single subcutaneous injection. About once-weekly IcoSema Once-weekly IcoSema is a fixed-ratio combination of a once-weekly basal insulin icodec and once-weekly semaglutide (700U/2 mg per millilitre). IcoSema is titrated in the same way as insulin, with a maximum weekly dose of 350 dose steps (ie 350 U insulin icodec/1mg semaglutide). About Novo NordiskNovo Nordisk is a leading global healthcare company founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 77,400 people in 80 countries and markets its products in around 170 countries. For more information, visit novonordisk.com, Facebook, Instagram, X, LinkedIn and YouTube. Contacts for further information Media: Ambre James-Brown +45 3079 9289abmo@novonordisk.comLiz Skrbkova (US)+1 609 917 0632lzsk@novonordisk.comInvestors: Jacob Martin Wiborg Rode+45 3075 5956jrde@novonordisk.comIda Schaap Melvold +45 3077 5649 idmg@novonordisk.comSina Meyer +45 3079 6656 azey@novonordisk.comMax Ung+45 3077 6414mxun@novonordisk.comFrederik Taylor Pitter +1 609 613 0568fptr@novonordisk.com 1 Novo Nordisk data on file.
Attachment
PR250610-ADA-Curtain-Raiser
–The Study Met Primary and All Secondary Efficacy Endpoints– Statistically Significant 35% Placebo-Adjusted Reduction from Baseline in Pulmonary Vascular Resistance for the Primary Endpoint (p
SAN DIEGO, June 10, 2025 (GLOBE NEWSWIRE) — Gyre Therapeutics (“Gyre”) (Nasdaq: GYRE), an innovative, commercial-stage biopharmaceutical company dedicated to advancing fibrosis-first therapies across organ systems affected by chronic disease, today announced that the first volunteer has been successfully dosed in a Phase 1 clinical trial evaluating F230, a novel endothelin A (“ETA”) receptor antagonist, for the treatment of pulmonary arterial hypertension (“PAH”).This milestone marks Gyre’s entry into the PAH field, a rare, progressive, and high-mortality cardiovascular condition with limited treatment options. PAH is recognized in China’s National Rare Disease Catalog, underscoring its significance in public health. According to Frost & Sullivan, China’s PAH market was valued at $370 million in 2023 and is projected to grow to $480 million by 2031.F230, originally discovered by Eisai Co., Ltd. and exclusively licensed by GNI Group Ltd. to Gyre, is a fully synthetic small molecule designed to selectively block the ETA receptor. By targeting this pathway, F230 is designed to reduce pulmonary vascular remodeling and lower pulmonary pressure, key contributors to PAH progression.The Phase 1 trial is designed to evaluate safety, tolerability, and pharmacokinetics in healthy volunteers. The trial represents the latest expansion of Gyre’s fibrosis-first strategy beyond the liver, leveraging a robust clinical development platform and commercial infrastructure in China.F230 joins Gyre’s pipeline alongside lead candidate Hydronidone (F351), which met the primary endpoint in a pivotal Phase 3 trial for CHB-fibrosis. A New Drug Application (“NDA”) submission to China’s National Medical Products Administration (“NMPA”) is planned for the third quarter of 2025, and a pre-IND meeting with the U.S. Food and Drug Administration is being planned for an expected Phase 2 trial in metabolic dysfunction-associated steatohepatitis (“MASH”) fibrosis.About Gyre TherapeuticsGyre Therapeutics is a biopharmaceutical company headquartered in San Diego, CA, primarily focused on the development and commercialization of Hydronidone for liver fibrosis, including MASH, in the U.S. Gyre’s strategy builds on its experience in mechanistic studies using MASH rodent models and clinical studies in CHB-induced liver fibrosis. In the People’s Republic of China, Gyre is advancing a broad pipeline through its indirect controlling interest in Gyre Pharmaceuticals, including therapeutic expansions of ETUARY, and development programs for F573, F528, and F230.Forward-Looking StatementsThis press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this press release, are forward-looking statements, including statements concerning the expectations regarding Gyre’s research and development efforts and timing of expected clinical trials, including an NDA submission to the NMPA for F351, the expected clinical benefits of F230 and expectations regarding interactions with regulators. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “plan” or the negative of these terms, and similar expressions intended to identify forward-looking statements. These statements reflect our plans, estimates, and expectations, as of the date of this press release. These statements involve known and unknown risks, uncertainties and other factors that could cause our actual results to differ materially from the forward-looking statements expressed or implied in this press release. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation: Gyre’s ability to execute on its clinical development strategies; positive results from a clinical trial may not necessarily be predictive of the results of future or ongoing clinical trials; the timing or likelihood of regulatory filings and approvals; competition from competing products; the impact of general economic, health, industrial or political conditions in the United States or internationally; the sufficiency of Gyre’s capital resources and its ability to raise additional capital. Additional risks and factors are identified under “Risk Factors” in Gyre’s Annual Report on Form 10-K for the year ended December 31, 2024 filed on March 17, 2025 and in other filings Gyre may make with the SEC. Gyre expressly disclaims any obligation to update any forward-looking statements whether as a result of new information, future events or otherwise, except as required by law.Investor Contact:David ZhangGyre Therapeuticsdavid.zhang@gyretx.com
LMNA-related dilated cardiomyopathy (LMNA DCM) is one of the most aggressive forms of DCM, affecting approximately 100,000 individuals in the United States and Europe, who progress rapidly to end-stage heart failure. NVC-001 demonstrated significant benefits, including survival and…
Enlicitide demonstrated statistically significant and clinically meaningful reductions in LDL-C in both Phase 3 CORALreef HeFH and CORALreef AddOn trials Enlicitide, a novel macrocyclic peptide, has the potential to be the first approved oral PCSK9 inhibitor RAHWAY, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside of the United States and […]
TEL AVIV, Israel, June 9, 2025 /PRNewswire/ — Microtech, a wholly owned subsidiary of Medinol, is happy to announce the first U.S. implantations of its atrial-pressure microsensor. Two surgical implantations were performed on Friday, May 16, 2025, at New York-Presbyterian/Columbia…
