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Treatment of Severe Heart Failure – AI: FineHeart Reinforces Its Industrial Credentials and Long-Term Strategy by Adding Manufacturing to Its ISO 13485: 2016 Certification

BORDEAUX, France–(BUSINESS WIRE)–FineHeart S.A., a clinical-stage medtech company developing breakthrough solutions for cardiology, announces the extension of its ISO 13485:2016 certification to cover all processes related to the production of its fully implantable cardiac assist device, the FlowMaker®. Issued following an audit conducted by BSI, an independent notified body of […]

Biome Analytics Launches Advanced ECMO, Heart Transplant, and LVAD Module

SAN FRANCISCO–(BUSINESS WIRE)–Biome Analytics, a leader in cardiovascular performance analytics, announces the launch of its newest module designed to enhance data-driven decision-making for ECMO, heart transplant, and LVAD programs. “As ECMO, heart transplant, and LVAD programs grow in complexity, actionable analytics are essential for delivering advanced therapies effectively and monitoring […]

Access Vascular Catheters with MIMIX® Technology Added to Recon Supply’s Federal Supply Schedule Contract

BILLERICA, Mass.–(BUSINESS WIRE)–Access Vascular, Inc. (AVI), a leader in tackling critical vascular access challenges with its advanced hydrophilic biomaterial technology, today announced that its portfolio of vascular access catheters made with MIMIX® technology has been added to Recon Supply’s Federal Supply Schedule (FSS) contract, as well as their Distribution and […]

CVRx announces new real-world evidence demonstrating significant reductions in healthcare utilization with Barostim

New real-world evidence presented at THT 2025 and published simultaneously in the Journal of Cardiac Failure (JCF) demonstrates large and statistically significant reductions in hospital visits and length of stay in patients with heart failure and reduced ejection fractionMINNEAPOLIS, Feb. 12, 2025 (GLOBE NEWSWIRE) — CVRx, Inc. (NASDAQ: CVRX) (“CVRx”), a commercial-stage medical device company, announced today the presentation of new real-world evidence at the Technology and Heart Failure Therapeutics (THT) conference in Boston. The study demonstrated large and statistically significant reductions in hospital visits (hospitalizations and emergency department visits) and length of stay after Barostim implantation, compared to before. The research was published simultaneously and is available now in the Journal of Cardiac Failure. “Despite contemporary medications, the clinical and economic burden of heart failure remains unacceptably high. This new study showing significant reductions in real-world healthcare utilization associated with the Barostim implant is critically important for clinicians and payers when considering this device for their patients,” said Jacob Abraham, MD, Section Head of Advanced Heart Failure at Providence Heart Institute in Portland, Ore. “While we know Barostim plus medications demonstrates long-term improvements in symptoms and quality of life, we now have compelling real-world evidence supporting a significant reduction in healthcare utilization as well.” This analysis was performed using data from the Premier Healthcare Database, a large all-payer database including data from more than 1,300 institutions. Three hundred and six (306) Barostim patients were identified in the data set. Comparisons were performed for the 12 months prior to Barostim implant and for an average of almost two years post-implant (1.92±1.87 years). Length of stay was found to be significantly reduced. Hospital visits (hospitalizations and emergency department visits) were categorized as all-cause, cardiovascular, and heart failure related. The analysis found: 86% reduction in all-cause hospital visits (p

Orchestra BioMed Announces Data Demonstrating Favorable Impact of AVIM Therapy on Diastolic Dysfunction, a Key Driver of Heart Failure Progression, will be Presented as Late-Breaking Science at the THT 2025 Conference

Late-breaking oral presentation features echocardiographic data analysis showing favorable impact of AVIM therapy on MODERATO II study patients with diastolic dysfunction, a key component in the development of heart failureHypertension is the leading cause of diastolic dysfunction; both conditions are common in older patients and contribute to the development of heart failure NEW HOPE, Pa., Feb. 12, 2025 (GLOBE NEWSWIRE) — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO) (“Orchestra BioMed” or the “Company”), a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced a late-breaking oral presentation of data on the benefits of atrioventricular interval modulation (“AVIM”) therapy on patients with diastolic dysfunction at the Technology and Heart Failure Therapeutics (“THT”) 2025 Conference in Boston, Massachusetts. The retrospective analysis of data from the MODERATO II study demonstrated that AVIM therapy significantly improved echocardiographic (“Echo”) markers of diastolic dysfunction, an important component in the development of heart failure, in hypertensive patients. The presentation titled “Effects of Atrioventricular Interval Modulation (AVIM) Therapy in Subjects with Hypertension and Diastolic Dysfunction” is being delivered in a late-breaking clinical science session at THT by Marat Fudim, M.D., M.H.S.​ Advanced Heart Failure Cardiologist, Duke Health on Wednesday, February 12, 2025, at 10:43am ET. Dr. Fudim commented, “For many patients with long-standing hypertension, the heart can undergo structural and functional changes that result in diastolic dysfunction, the progression of which is directly linked to the development of heart failure. By reducing systolic blood pressure and favorably impacting intra-cardiac pressures and volumes, AVIM therapy directly affects diastolic filling and myocardial relaxation. This analysis of MODERATO II data provides exciting insights that suggest that, beyond lowering systolic blood pressure, AVIM therapy improves diastolic function and leads to favorable ventricular remodeling. Given the strong link between uncontrolled hypertension, diastolic dysfunction, and heart failure, these findings highlight the opportunity to intervene earlier and leverage AVIM therapy for the prevention of heart failure.” Key Findings: A retrospective, treatment-blinded analysis of MODERATO II assessed the impact of 6 months of AVIM therapy on systolic blood pressure (“SBP”) and Echo markers of diastolic dysfunction (“DD”) using core lab Echos with independent blinded adjudication. Patients were classified as with DD (“DD+”) or without DD (“DD-”) using ​the American Society of Echocardiography Guidelines. From the MODERATO II study cohort (n=47), 36 patients had technically sufficient Echo data, and 61% of this group (22/36) had Echo evidence of DD. Using key measures of diastolic function, AVIM therapy: Significantly reduced office and ambulatory SBP in patients ​with DD through 6 months Ambulatory SBP (“aSBP”) was reduced in AVIM-treated DD+ patients (N=12) by 8.3±9.7 mmHg (p

CorVista Health Announces Leadership Succession, Appointing Adrian Lam as President and CEO

Adrian Lam appointed President and CEO of CorVista HealthDon Crawford to retire following a distinguished 42-year career in MedTechTim Attebery to serve as Chairman of the Board of Directors BETHESDA, Md., Feb. 12, 2025 (GLOBE NEWSWIRE) — CorVista Health today announced that Don Crawford will retire from his role as President and Chief Executive Officer (CEO) after a successful ten-year tenure. The Board of Directors has appointed Adrian Lam to the role of President and Chief Executive Officer. Tim Attebery, CEO of Cardiovascular Associates of America, former CEO of the American College of Cardiology (ACC) and current Board Director, will become Board Chairman. “It has been a privilege working with an exceptionally talented and dedicated team, united by a shared passion for improving cardiovascular care,” Don Crawford said. “Adrian is a dynamic, resourceful, and decisive leader who is perfectly suited to advance CorVista’s mission. He brings a proven track record of developing innovative products, building high-performing teams, and translating advanced technology into impactful medical products that improve patient outcomes.” “I am incredibly honored to lead such an innovative and mission-driven organization. The team is at the forefront of AI-enabled cardiovascular diagnostics and it’s amazing to see real patient impact even from its early days of launch. The system is able to achieve, in the doctor’s office, levels of diagnostic accuracy normally reserved for radiology. This opens up CorVista to rural and remote populations, where there is trouble with access to radiology or specialist cardiology care,” said Adrian Lam. Under Crawford’s leadership, CorVista Health has launched two pivotal U.S. Food and Drug Administration (FDA) cleared products, including the first major advancement in Pulmonary Hypertension (PH) diagnostics in more than 40 years, which secured an FDA Breakthrough Designation. He will remain on as Special Advisor to the CEO to ensure a smooth leadership transition. “As Don transitions out of his role, we want to thank him for his many years of dedicated service. We are proud of the foundation he built and look forward to partnering with Adrian to deliver on our promise to transform cardiovascular care,” said Tim Attebery. “Adrian’s diverse background as an investor-operator and a seasoned business executive uniquely positions him to navigate the future of our business and deliver meaningful value to our patients, providers, and stakeholders.” Adrian brings over 20 years of expertise in global MedTech, BioTech, and Life Science Tools. At Stryker, he led the Advanced Biomaterials R&D Group, spearheading development of multiple FDA-cleared products. As an early executive at Genesis Medtech, he helped scale the company from startup to unicorn in just over a year, driving innovation, business development, and operational integration. Previously, he managed an equity portfolio at the healthcare fund Sectoral Asset Management, building a global network of investors and industry leaders. He is also the founder of Bioworld Ventures, an investment and company-building platform run by healthcare executives and entrepreneurs. Adrian holds degrees in Biomedical Engineering and Economics from Duke University. 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.corvistahealth.com Contacts CorVista Health Media RelationsEmail: media@corvistahealth.com

Windtree Announces Special Late-Breaking Clinical Science Abstract Presentation on Istaroxime at the Technology and Heart Failure Therapeutics Conference

WARRINGTON, Pa., Feb. 12, 2025 (GLOBE NEWSWIRE) — Windtree Therapeutics, Inc. (“Windtree” or the “Company”) (NasdaqCM: WINT), a biotechnology company focused on advancing early and late-stage innovative therapies for critical conditions and diseases, announced that an istaroxime presentation featuring the positive Phase 2b SEISMiC study was given on February 11, 2025 at the Technology and Heart Failure Therapeutics Conference in Boston, MA.

Bioxodes secures new funds to reach early 2025 milestones and pursue Series B financing

Bioxodes raises €2.7 million from existing investors in Series A extensionInterim data from BIRCH intracerebral hemorrhage (ICH) Phase 2a trial in Q1 2025Recruitment of up to 16 additional patients continues in BIRCH BIOX-101 Phase IIb ICH study preparations ongoing, to start upon close of Series B Gosselies (Belgium), 12 February 2025 (08:30 am CET) – Bioxodes SA, a clinical stage biopharmaceutical company developing novel therapies for the prevention and treatment of thrombotic and inflammatory diseases, has raised €2.7 million from existing investors in an extension of its Series A funding round, now totaling about €15 million. The proceeds will allow the company to deliver full results from BIRCH, its Phase 2a trial of BIOX-101 to treat intracerebral hemorrhage (ICH), an orphan disease with no currently approved therapeutic intervention, and prepare for the launch of a potentially registrational Phase 2b trial of BIOX-101 for ICH. “The Series A extension is an important financial commitment from our existing investors, and an invaluable sign of confidence in the future of Bioxodes,” said Marc Dechamps, Chief Executive Officer at Bioxodes. “We are at a crucial moment in the development of BIOX-101, a first-in-class therapeutic to treat the devastating effects of intracerebral hemorrhagic stroke, a high unmet medical need. In the first half of this year, we will update investors about a number of crucial milestones, including the strengthening of our top management, interim results from the BIRCH Phase 2a study, a decision about the Orphan Drug Designation of BIOX-101, and our Series B funding round.” Recruitment for the randomized, open-label BIRCH trial is continuing after Bioxodes enrolled the first 16 patients in December. Bioxodes is planning to present an interim analysis of these patients when the data become available. Bioxodes is also expecting an imminent response from U.S. and EU regulators about its Orphan Drug Designation for BIOX-101, which it applied for in the fourth quarter of 2024. ICH is classified as an orphan disease in U.S. and Europe; drugs developed for orphan indications can have relatively rapid and cost-effective paths to market compared to other drugs. For example, the Phase 2b trial of BIOX-101 could be sufficient to register the product for marketing authorization before the end of this decade. At the same time, Bioxodes is working to ramp up production of BIOX-101 for a potential registrational international Phase 2b trial, which it plans to launch early next year, with recruitment expected to start in the first quarter of 2027. The Chemistry, Manufacturing and Controls (CMC) required to generate BIOX-101 for Phase 2b will take approximately a year to complete. Bioxodes is launching a series B funding round of about 50 million in Q2 2025, to support CMC and clinical development for BIOX-101, as well as to develop the drug candidate for additional indications including ischemic stroke and undisclosed thrombo-inflammatory diseases. In addition, Bioxodes will research other novel options to treat thrombotic and inflammatory diseases. BIOX-101 is synthesized based on a small protein found in the saliva of the tick1. It is designed to reduce the harmful secondary brain injuries that occur after a hemorrhagic stroke. BIOX-101 has demonstrated striking benefits in preclinical proof-of-concept studies, including the prevention of blood clot formation, as well as a reduction in detrimental neuroinflammation after an ICH. Unlike anticoagulants currently marketed to prevent blood clot formation, BIOX-101 reduces clotting without increasing the risk of bleeding. BIOX-101 also inhibits the activation of neutrophils and their release of extracellular DNA filaments (called NETs), which can cause excessive inflammation, exacerbating brain damage and disrupting the blood-brain barrier About Bioxodes Bioxodes is a clinical stage biopharmaceutical company developing novel therapies for the prevention and treatment of thrombotic and inflammatory diseases. Since its founding in 2013, Bioxodes has developed its lead asset BIOX-101, a first-in-class drug candidate aimed at patients with thrombo-inflammatory disease. BIOX-101’s unique mechanism of action is the foundation of an innovative pipeline of drug candidates for the prevention of (thrombo-)inflammatory diseases. Worldwide, Bioxodes holds both granted and pending patents associated with BIOX-101. Bioxodes research is supported by the Walloon Region, and the company is registered in Belgium under number 825.151.779. For more information please visit www.bioxodes.com or contact: HEAD OFFICES BioPark Charleroi-Bruxelles Sud Rue Santos-Dumont, 1 6041 Gosselies, Belgium+32 496 590354investment@bioxodes.com MEDIA RELATIONSAlexandra Schiettekatte communication@bioxodes.com +32 476 65 04 38   COHESION BUREAU EU MEDIA RELATIONSSophie Baumont sophie.baumont@cohesionbureau.com INVESTOR RELATIONS Giovanni Ca’ Zorzi giovanni.cazorzi@cohesionbureau.com     1 Ixodes ricinus
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20250211 – Bioxodes PR Series A extension – final

RenovoRx Announces Closing of $12.1 Million Underwritten Public Offering of Common Stock

MOUNTAIN VIEW, Calif.–(BUSINESS WIRE)–RenovoRx, Inc. (“RenovoRx” or the “Company”) (Nasdaq: RNXT), a life sciences company developing novel targeted oncology therapies and commercializing RenovoCath®, an innovative, FDA-cleared delivery platform, today announced the closing of its previously announced $12.1 million firm commitment underwritten public offering of common stock led by multiple fundamental […]

Reprieve Cardiovascular Builds Clinical Momentum with Positive Results from FASTR Pilot Trial and FDA Investigational Device Exemption Approval for Pivotal Trial

— Late-Breaking Clinical Data Presented at the Technology and Heart Failure Therapeutics (THT) Annual Meeting Demonstrates Safety and Efficacy of the Reprieve System Compared to Optimal Diuretic Therapy to Manage Fluid Volume Overload — — Company Plans Initiation of Randomized Pivotal Trial in the First Half of 2025 to Support Premarket […]