The Latest Cardiac and Vascular News
Largest hypertension trial of an aldosterone synthase inhibitor to date demonstrated the efficacy of lorundrostat in over 1,000 participants with uncontrolled or resistant hypertension in a real-world setting – – Lorundrostat 50 mg dosed once daily demonstrated clinically meaningful and sustained reductions in systolic blood pressure, with a 16.9 mmHg reduction […]
SHANGHAI, May 27, 2025 (GLOBE NEWSWIRE) — Shanghai Junshi Biosciences Co., Ltd (Junshi Biosciences, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced that the National Medical Products Administration (the “NMPA”) has approved two supplemental new drug applications for the ongericimab injection (a recombinant humanized anti-PCSK9 monoclonal antibody injection, trade name: JUNSHIDA (君适达®)) for: 1) adult patients with heterozygous familial hypercholesterolemia (“HeFH”); 2) alone or in combination with ezetimibe, in adult patients with non-familial hypercholesterolemia and mixed dyslipidemia who are statin-intolerant or statins contraindicated. Ongericimab has become China’s first domestic PCSK9-targeted drug approved for statin-intolerant patients. According to the Chinese Guidelines for Lipid Management (2023), cardiovascular disease is the leading cause of death among both urban and rural residents in China, with atherosclerotic cardiovascular disease (“ASCVD”) being the predominant subtype. The rise of low-density lipoprotein cholesterol (“LDL-C”) levels is a major cause of ASCVD. Lowering LDL-C levels can significantly decrease the incidence of ASCVD and risk of death. HeFH is a common type of familial hypercholesterolemia with an estimated prevalence of 1:250 ~ 1:200, and its main clinical features are significantly elevated LDL-C and early onset of coronary artery disease. Compared to patients with non-familial hypercholesterolemia, patients with HeFH exhibit higher baseline LDL-C levels and lower target levels for control recommended by the guidelines. Failure to achieve target LDL-C levels after treatments such as statins will result in patients being at high cardiovascular risk. In addition, despite statins currently being the cornerstone of lipid-lowering treatment, approximately 9.1% of patients clinically exhibit statin intolerance, with a higher proportion observed in Asian populations. Discontinuation of statins or the use of only tolerable doses in patients with statin intolerance may lead to suboptimal LDL-C levels, thereby failing to effectively reduce the patient’s ASCVD risk. As a new lipid-lowering drug that effectively reduces LDL-C levels, PCSK9 inhibitor has been recommended in the guidelines for the management of lipids both in China and overseas and is widely recognized by clinicians. The significant lipid-lowering effects of ongericimab have been demonstrated in multiple phase 3 clinical studies, and ongericimab was approved by the NMPA for the treatment of adult patients with primary hypercholesterolemia (non-familial) and mixed dyslipidemia in October 2024. The approval of the two supplemental new drug applications are mainly based on two registered clinical trials—JS002-005 (NCT05325203) and JS002-007 (NCT05621070). JS002-005 is a randomized, double-blind, placebo-controlled Phase 3 clinical study in adult patients with HeFH. JS002-005 was led by Professor Changsheng MA and Professor Jie LIN from Beijing Anzhen Hospital affiliated to Capital Medical University as the principal investigators. A total of 135 patients with HeFH were enrolled. This study is the first Phase 3 clinical study evaluating an anti-PCSK9 monoclonal antibody in Chinese patients diagnosed with HeFH (DLCN >8). The latest data on JS002-005 has been published in full in Atherosclerosis. The results showed that, compared with placebo, the ongericimab subcutaneous injection (150 mg every 2 weeks (Q2W) or 450 mg every 4 weeks (Q4W)) significantly reduced LDL-C levels by 69.4% and 80.6% (p
ATLAS™ Sternal Repair Matrix is intended for challenging sternal fusion cases and IKON™ Allograft Surgical Matrix assists with soft tissue repair in high-risk patients MTF Biologics and Kolosis BIO Launch Two New Allografts to Advance Cardiac Surgery EDISON, N.J. & SALT LAKE CITY–(BUSINESS WIRE)–MTF Biologics, a global nonprofit organization that […]
WASHINGTON—A new expert opinion document jointly released by the Society for Cardiovascular Angiography and Interventions (SCAI) and the Society of Cardiovascular Computed Tomography (SCCT) presents a comprehensive framework for using coronary computed tomography angiography (CCTA) to guide percutaneous coronary intervention (PCI). Published in JSCAI, “Coronary Computed Tomography Angiography to Guide […]
At the EuroPCR 2025 Congress – Paris Results confirm the promise of non-invasive ultrasound therapy (NIUT) previously observed in earlier clinical studies. 91% of patients were free of major adverse cardiac events (MACE) at 30 days (achieving the primary endpoint objective MACE ≤ 25%). 85% of patients experienced an improvement or stabilization […]
PARIS–(BUSINESS WIRE)–Edwards Lifesciences (NYSE: EW) today announced new economic and clinical evidence on severe aortic stenosis (AS) presented as a late-breaking clinical trial at EuroPCR 2025, further contributing to the extensive body of research on this disease. The results of a new real-world study of more than 24,000 patients demonstrated […]
Paris, May 21, 2025 (GLOBE NEWSWIRE) — —Sustained durability of treatment effect with significantly lower TLF rates (2.7% versus 7.2%, p=0.030) with DynamX® compared to DES— —Significantly lower rate of Cardiac Death (0.5% versus 3.2%, p=0.033) with DynamX® compared to DES— Paris – May 21, 2025 – Elixir Medical, a developer of transformative technologies to treat cardiovascular and peripheral disease, today announced three-year results from the large 445-patient BIOADAPTOR Randomized Controlled (1:1) Trial (RCT), comparing the DynamX® Coronary Bioadaptor System to standard of care Resolute OnyxTM Drug-Eluting Stent (DES) from 34 centers in Japan, Europe, and New Zealand. The results demonstrate sustained very low adverse events and durability of clinical outcomes with DynamX® bioadaptor in target lesion failure (TLF) and Cardiovascular Death (CVD) compared to non-plateauing increase in adverse events in the DES arm. The data were presented at a late-breaking clinical session during the EuroPCR 2025 conference in Paris. Clinical results show sustained significant reduction of device-oriented adverse events with DynamX® bioadaptor over the drug-eluting stent at three years: Significant reduction in TLF rate (2.7% versus 7.2%; p=0.030) demonstrating the durability of DynamX® treatment through three years of follow-up. The significant reduction in TLF was driven by low adverse events across all components of the composite endpoint with DynamX® compared to DES, respectively: Significantly lower Cardiovascular Death (0.5% versus 3.2%, p=0.033)Target Vessel Myocardial Infarction (0.9% versus 1.8%)Ischemia-Driven Target Lesion Revascularization (1.4% versus 2.7%) Reduction in adverse events amplified in Left Anterior Descending (LAD) artery lesions: Significantly lower TLF rate in LAD lesions (2.7% versus 10.6%; p=0.019) consistent with bioadaptor mechanism of action of restoring vessel function in this hemodynamically critical coronary vessel as reported previously in the imaging subgroup at 12 months1. “These three-year results from the BIOADAPTOR RCT demonstrate that DynamX bioadaptor provides for a new class of treatment—with significant clinical benefit from six months when the bioadaptor mechanism of action is activated and sustained through long-term follow-up, including the hard clinical endpoint of cardiovascular death,” said Shigeru Saito, M.D., director of the Division of Cardiology and Catheterization Laboratory at Shonan Kamakura General Hospital in Kamakura, Japan. “We also see the heightened importance of restoring hemodynamic modulation in the LAD vessel demonstrated by the large difference in clinical events in LAD lesions between the two treatment arms.” The DynamX bioadaptor is differentiated from the current therapies, having a novel mechanism of action designed to return vessel health through three distinct phases of adapting in the body to restore vessel biology. In the locked phase during the implant, the bioadaptor opens the artery and restores blood flow. Unique to bioadaptor, after six months the implant unlocks, separates into three helical strands, releasing the vessel and providing dynamic support to maintain the established blood flow lumen. The continued adaptive dynamic support helps return vessel hemodynamic modulation through restoration of pulsatility and adaptive blood flow volume and has also shown evidence of plaque stabilization and regression in the lesion. “With these results, we are pleased to demonstrate that restoring hemodynamic modulation of the artery translates to lasting clinical outcomes, elevating the level of care for patients,” said Motasim Sirhan, CEO of Elixir Medical. “With the three-year BIOADAPTOR-RCT data presented today, and the results from the 2,400 patient INIFINITY-SWEDEHEART RCT published in The Lancet, we have shown consistently across multiple trials significantly lower, plateauing clinical events after six months with DynamX® bioadaptor compared to DES, validating the benefit of our transformative technology.” About BIOADAPTOR RCT TrialThe BIOADAPTOR RCT is an international, single-blind, randomized controlled (1:1) trial comparing a sirolimus-eluting bioadaptor with a contemporary zotarolimus-eluting stent in 445 patients in 34 centers in Japan, Europe, and New Zealand. Both arms had large randomized multi-modality imaging subgroups of 50 patients each to document standard effectiveness benchmarks of establishing and maintaining artery flow lumen measured by percent diameter stenosis (%DS) and late lumen loss (LLL), and the new effectiveness benchmarks of restoring artery hemodynamic modulation, including pulsatility, vessel compliance, adaptive flow volume, and plaque stabilization and regression. Clinical follow-up will continue through five years. BIOADAPTOR RCT trial is the third trial of Elixir Medical’s robust DynamX® bioadaptor clinical evidence program consisting of nine company-sponsored and investigator-initiated studies involving over 9,000 patients, including INFINITY SWEDEHEART RCT (n=2400) and a global BIO-RESTORE registry with a target enrollment of up to 5,000 patients. About DynamX Coronary Bioadaptor SystemThe DynamX® bioadaptor is the first coronary implant technology designed to restore coronary artery hemodynamic modulation as demonstrated by restored vessel pulsatility, compliance, and adaptive increase in blood flow volume, and providing plaque stabilization and regression. With its unique mechanism of action (MOA), it addresses the shortcomings of drug-eluting stents and bioresorbable scaffolds (BRS) with remarkably low clinical event rates that showed a plateau from six months through three-year clinical follow-up. The DynamX® Coronary Bioadaptor System is CE-marked. The DynamX® Sirolimus Eluting Coronary Bioadaptor System is an investigational device. Limited by Federal (or United States) law to investigational use. About Elixir MedicalElixir Medical Corporation, a privately held company based in Milpitas, California, develops disruptive platforms to treat coronary and peripheral artery disease. Our transformative technologies have multiple applications across the cardiovascular space capable of delivering improved clinical outcomes for millions of patients. Elixir Medical was named to Fast Company’s prestigious list of the World’s Most Innovative Companies of 2025. Visit us at www.elixirmedical.com and on LinkedIn. Media ContactRichard LaermerRLM PRelixir@rlmpr.com(212) 741-5106 X 216 1 Saito S et al. 12-Months Outcomes BIODAPTOR-RCT. The Lancet eClinicalMedicine. 2023;65:102304.
EMPOWER CAD, a global prospective, multi-center, real-world study, reaffirms favorable acute outcomes for coronary IVL in female patients, unlike other calcium modification tools PARIS, May 20, 2025 /PRNewswire/ — Shockwave Medical, Inc., part of Johnson & Johnson MedTech and a global…
May 20, 2025
RADNOR, Pa., May 20, 2025 (GLOBE NEWSWIRE) — Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone, today announced that data from the pivotal Phase 3 Launch-HTN trial evaluating the efficacy and safety of lorundrostat for the treatment of uncontrolled hypertension (uHTN) or resistant hypertension (rHTN) will be presented in a late-breaking clinical trials session at the 34th European Meeting on Hypertension and Cardiovascular Protection (ESH 2025), which will be held in Milan at the MICO Congress Center, on May 23-26, 2025. Details for the Late-Breaking Clinical Trial Abstract: Abstract Title:Phase 3 Efficacy and Safety of a Novel Aldosterone Synthase Inhibitor in Patients with Uncontrolled and Treatment-Resistant Hypertension: Launch-HTN StudyPresenter:Manish Saxena MBBS, Hypertension Specialist from Barts Health NHS Trust and William Harvey Heart Centre, Queen Mary University LondonSession Date/Time:Saturday, May 24th, at 10:00-11:00am CESTSession Title:Late Breakers 1Session Location:Aqua 1 About Lorundrostat Lorundrostat is a proprietary, orally administered, highly selective aldosterone synthase inhibitor being developed for the treatment of uHTN and rHTN as well as CKD. 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 approximately a 70% reduction in plasma aldosterone concentration in hypertensive subjects. In a Phase 2, proof-of-concept trial (Target-HTN) in uncontrolled or resistant hypertensive subjects, once-daily lorundrostat demonstrated clinically meaningful blood pressure reduction in both automated office blood pressure measurement and 24-hour ambulatory blood pressure monitoring. Adverse events observed were a modest increase in serum potassium, decrease in estimated glomerular filtration rate, urinary tract infection and hypertension with one serious adverse event possibly related to study drug being hyponatremia. About Mineralys Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, CKD, OSA and other diseases driven by dysregulated aldosterone. Its initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor that Mineralys Therapeutics is developing for the treatment of cardiorenal conditions affected by dysregulated aldosterone, including hypertension, CKD and OSA. Mineralys is based in Radnor, Pennsylvania, and was founded by Catalys Pacific. For more information, please visit https://mineralystx.com. Follow Mineralys on LinkedIn and Twitter. 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 Company’s expectation that aldosterone synthase inhibitors with an SGLT2 inhibitor may provide additive clinical benefits to patients; the Company’s expectation that Advance-HTN and Launch-HTN may serve as pivotal trials in any submission of a new drug application (NDA) to the United States Food and Drug Administration (FDA); the Company’s ability to evaluate lorundrostat as a potential treatment for CKD, uHTN or rHTN; the planned future clinical development of lorundrostat and the timing thereof; and the expected timing of commencement and enrollment of patients in clinical trials and topline results from clinical trials. 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: 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; later developments with the FDA may be inconsistent with the feedback from the completed end of Phase 2 meeting, including whether the proposed pivotal program will support registration of lorundrostat which is a review issue with the FDA upon submission of an NDA; 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; 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 Mitsubishi Tanabe Pharma 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 RelationsTom WeibleElixir Health Public RelationsPhone: (1) 515-707-9678Email: tweible@elixirhealthpr.com
