Coronary/Structural Heart

Vectorious Medical Technologies Reports Novel Findings From VECTOR HF Trials: Self-Management of Heart Failure Patients Using Left Atrial Pressure

TEL AVIV, Israel, July 8, 2024 /PRNewswire/ — Vectorious Medical Technologies Ltd. announces the publication of a breakthrough pilot clinical study, which evaluated the V-LAP system and a novel therapeutic approach for heart failure, in the European Journal of Heart Failure.

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Vectorious: Self-Management of Heart Failure Patients Using Left Atrial Pressure via V-LAP to Prevent Disease Deterioration and Repeated Hospitalizations

Vectorious has developed a miniature digital pressure sensor (V-LAP) that measures left atrial pressure and is implanted in the heart’s interatrial septum using a minimally invasive catheterization procedure. The sensor transmits data that allows physician-directed, patient self-management of chronic heart failure, a prevalent and complex form of heart disease affecting approximately 1-2% of the population. Through a dedicated mobile application and based on daily data transmitted from the left atrium, patients self-adjust their diuretic dosage with the aim of preventing disease deterioration and repeated hospitalizations.

The study demonstrated for the first time that self-management of heart failure based on left atrial pressure (LAP) is both safe and feasible. At 12 months of follow-up, no complications or side effects related to the system were reported. Additionally, patient adherence to treatment was high, and significant improvements were observed in quality-of-life measures, coupled with a reduction in hospitalizations due to heart failure.
“This groundbreaking study marks a significant milestone in heart failure management by placing control directly in the hands of patients. This approach, akin to the empowerment seen in diabetes management, enables heart failure patients, under the guidance of their heart failure management team, to monitor and manage their condition safely with ease and confidence. By fostering greater patient autonomy, this innovative shift is set to dramatically enhance care quality and outcomes for this vulnerable population.” Said David Meerkin, MBBS, Interventional Cardiologist participating in the pilot VECTOR-HF study.To date, 55 V-LAP sensors have been successfully implanted in patients across Europe and Israel, accumulating over 40,000 days of LAP monitoring. This summer, implantations are planned to begin in leading heart centers in the United States, marking the next phase in the expansion of Vectorious’ clinical trials.”This study marks another significant step in realizing the transformative potential of patient self-management guided by left atrial pressure monitoring. By empowering patients with real-time hemodynamic data and decision-making tools, this innovative approach may not only enhance patient-centered outcomes but also shift the paradigm towards proactive and personalized heart failure care.” Said William T Abraham, Professor of Medicine from The Ohio State University Wexner Medical Center and one of the pioneers in implantable hemodynamic monitoring systems for heart failure patients.Eyal Orion, co-founder and CEO of Vectorious, added: “Publishing the research in a top-tier scientific journal is a historic milestone for the company, which has been developing not only one of the most complex medical systems but also a new therapeutic approach for over a decade. Transferring part of the responsibility to patients requires advanced, reliable, and accurate technology, and this is a challenge that requires perseverance and patience. We still have a way to go to fundamentally change the way the most common heart disease is understood and treated, but together with the amazing Vectorious team, physicians, and our partners, we are getting closer step by step.”About Vectorious Medical Technologies Ltd.Vectorious is a privately held company based in Tel Aviv, Israel, founded in 2011. The company’s V-LAP System enables heart failure patients to better control their disease by monitoring the heart’s Left Atrial Pressure (LAP) and detecting fluid accumulation in the earliest stages of the disease, prior to physiological symptoms. A mobile app further empowers patients to self-titrate medication in real-time based on data extracted from the heart. For more information, please visit the company website.Contact:Lili Arbely-ElbazVectorious Medical Technologies.+972-(0)525909192[email protected]Photo – https://mma.prnewswire.com/media/2455810/Vectorious_V_LAP.jpgSOURCE Vectorious Medical Technologies Ltd.

Amarin Partner EddingPharm Receives Regulatory Approval for VASCEPA® (Icosapent Ethyl) in Mainland China for Cardiovascular Risk Reduction (CVRR)

— VASCEPA Approved by the National Medical Products Administration (NMPA) To Reduce the Risk of Cardiovascular Events as an Adjunct to Statin Therapy in Adult Patients with Elevated Triglyceride (TG) Levels (≥150 mg/dL) and Other High-Risk Characteristics as Studied in REDUCE-IT — — EddingPharm Now Working to Prepare for National Reimbursement and Drug Listing (NRDL) and Enhance the Commercial Launch of VASCEPA Across Mainland China — DUBLIN and BRIDGEWATER, N.J., July 08, 2024 (GLOBE NEWSWIRE) — Amarin Corporation plc (NASDAQ:AMRN) today announced that its commercial partner in Mainland China (“China”), EddingPharm (EDDING), has received regulatory approval for VASCEPA® (icosapent ethyl) from China’s National Medical Products Administration (NMPA). NMPA granted approval for VASCEPA to reduce the risk of cardiovascular events as an adjunct to statin therapy in adult patients with elevated and high triglycerides (≥150mg/dL) and established cardiovascular disease or diabetes mellitus with ≥2 other cardiovascular disease risk factors, combined with hypertriglyceridemia. Following approval by NMPA, EDDING is working to include VASCEPA on the National Reimbursement Drug Listing (NRDL) and augment the ongoing commercial launch of VASCEPA in China to include the CVRR indication. The NRDL is updated annually and serves as the primary pathway for public reimbursement of pharmaceutical products in China, covering 98% of the Chinese population. Inclusion on the NRDL provides full or partial reimbursement at the national level. Products included in this listing can be prescribed from public hospitals in China. According to a recent report on cardiovascular health and disease in China,i cardiovascular disease (CVD) accounted for 44-47% of all death in urban and rural areas in China, meaning two out of every five deaths were due to CVD. It is estimated that 330 million patients suffer from CVD in China,i and that China has one of the highest CVD death rates in the world.ii According to the World Heart Federation, cardiovascular events, such as ischemic heart disease and stroke, are projected to increase by 50 percent among the population in China between 2010 and 2030 (based on population aging and growth alone).ii “We congratulate our partner, EDDING, on the regulatory approval of VASCEPA for cardiovascular risk reduction in China, as this marks an important step in helping broaden access to this novel treatment for patients across that country,” said Steven Ketchum, Ph.D., President, Research & Development and Chief Scientific Officer, Amarin. “This milestone is a major step forward to help ensure that the unique benefits of VASCEPA are accessible to patients throughout the world. We look forward to EDDING’s continued progress in introducing VASCEPA to patients at-risk for a cardiovascular event across China.” “The approval of the CVRR indication will allow many patients with atherosclerotic disease (ASCVD) in China to benefit from this innovative drug,” said EDDING. “In the future, we will continue to expand the application of VASCEPA® in the management of cardiovascular diseases to meet the unmet clinical needs of more Chinese patients.” As part of the approval, NMPA has requested that EDDING conduct a post-approval study after the product is marketed to further verify the efficacy of the product to reduce the risk of cardiovascular events in Chinese patients and provide a post-approval study report to conduct a life-cycle benefit-risk assessment at the time of product renewal. Product renewal is required five years post the approval of the product. Under the partnership agreement, EDDING is responsible for development and commercialization activities in the China territory and associated expenses. Amarin provides development assistance and is responsible for supplying finished bulk product. Based upon the NMPA approval for the CVRR indication, Amarin will earn a regulatory milestone payment in the amount of $15 million. EDDING will also pay Amarin tiered double-digit percentage royalties on net sales of VASCEPA in the territory. Amarin will supply product to EDDING under negotiated supply terms. About Amarin    Amarin is an innovative pharmaceutical company leading a new paradigm in cardiovascular disease management. We are committed to increasing the scientific understanding of the cardiovascular risk that persists beyond traditional therapies and advancing the treatment of that risk for patients worldwide. Amarin has offices in Bridgewater, New Jersey in the United States, Dublin in Ireland, Zug in Switzerland, and other countries in Europe as well as commercial partners and suppliers around the world. 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, a unique form of eicosapentaenoic acid. VASCEPA was launched in the United States in January 2020 as the first and only drug approved by the U.S. FDA for treatment of the studied high-risk patients with persistent cardiovascular risk after 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 20 million times. VASCEPA is covered by most major medical insurance plans. In addition to the United States, icosapent ethyl is approved and sold in Canada, Lebanon, and the United Arab Emirates. 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. VAZKEPA is being commercialized in multiple European countries, including England, Wales, Spain, Sweden and Finland. 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.  Europe For further information about the Summary of Product Characteristics (SmPC) for VAZKEPA® in Europe, please click here.  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 the regulatory approval of VASCEPA in China and the potential impact in that territory; Amarin’s overall efforts to expand access and reimbursement to VAZKEPA across global markets; and the overall potential and future success of VASCEPA/VAZKEPA generally. 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 full year ended 2022. 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. Availability of Other Information About Amarin  Amarin communicates with its investors and the public using the company website (www.amarincorp.com) and the investor relations website (investor.amarincorp.com), including but not limited to investor presentations and FAQs, Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that Amarin posts on these channels and websites could be deemed to be material information. As a result, Amarin encourages investors, the media and others interested in Amarin to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on Amarin’s investor relations website and may include social media channels. The contents of Amarin’s website or these channels, or any other website that may be accessed from its website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.  Amarin Contact Information Media & Investor Inquiries:  Mark Marmur Amarin Corporation plc   PR@amarincorp.com ______________________________ i The Writing Committee of the Report on Cardiovascular Health and Diseases in China. Report on Cardiovascular Health and Diseases in China 2021: An Updated Summary[J]. Biomedical and Environmental Sciences, 2022, 35(7): 573-603. doi: 10.3967/bes2022.079ii World Heart Federation Fact Sheet: Cardiovascular Disease in China. chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://world-heart-federation.org/wp-content/uploads/2017/05/Cardiovascular_diseases_in_China.pdf

Ultromics granted Category III CPT reimbursement code for EchoGo® Heart Failure

OXFORD, England, July 2, 2024 /PRNewswire/ — Ultromics announced today that the American Medical Association (AMA) has issued a Category III Current Procedural Terminology (CPT) code for EchoGo® Heart Failure, a crucial advancement in enhancing the accessibility of Ultromics’ ground-breaking technology in hospital outpatient settings.

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The American Medical Association (AMA) has issued a Category III CPT® code (0923T) for reimbursing EchoGo® Heart Failure.

EchoGo® Heart Failure uses AI to detect heart failure with preserved ejection fraction (HFpEF) from a single, routinely acquired echocardiographic video. The technology leverages large datasets and advanced algorithms to identify patterns and correlations that may go undetected by traditional diagnostic methods. The AI insights aid clinicians in diagnosis, monitoring, and expediting treatment responses, significantly enhancing the detection and management of patients with this challenging subtype of heart failure.

This is the only artificial intelligence CPT code specific to supporting HFpEF diagnosis through echocardiography and was released on July 1st this year on the AMA’s website, becoming effective January 1st, 2025. The new CPT code, 0923T, will replace the previous HCPCS outpatient code for EchoGo® Heart Failure, C9786.  EchoGo® Heart Failure is also covered in the hospital inpatient setting, using the New Technology Add-on Payment (NTAP) code XXE2X19.
Ross Upton, PhD, Chief Executive Officer and founder of Ultromics, stated, “This recognition by the AMA underscores the significant impact our technology is having in the field of heart failure care. HFpEF represents a significant and growing patient population, accounting for 50% of heart failure cases worldwide, and may go undiagnosed in up to 64% of cases.1  We believe that EchoGo® Heart Failure will transform diagnostic pathways for these patients, enable earlier intervention, improve quality of life, and deliver benefits to payors and healthcare systems.”In the US, CPT codes are used by public and private health insurance programs and offer doctors and healthcare professionals a method to identify medical services and procedures for reimbursement. Category III CPT codes are temporary codes assigned to new and developing technologies, procedures, and services.Additional Data on EchoGo® Heart FailureEchoGo® Heart Failure was granted FDA 510(k) clearance in December 2022 and has been awarded FDA Breakthrough Device Designation.2Recent data on the tool was published last year in JACC: Advances, showing superior efficacy of EchoGo® Heart Failure in identifying HFpEF over the current clinical standard.Specifically, the AI-based system was able to correctly assign a diagnosis to 74% of patients who had returned non-diagnostic results on the commonly used HFA-PEFF and H2FPEF clinical scores.3 This improvement could translate to more patients receiving accurate and timely diagnoses and management.EchoGo® Heart Failure demonstrated high sensitivity and specificity, detecting 88% of patients who had HFpEF, and 82% of patients that did not.3 These results exceed what is usually observed in routine clinical practice.For the study, investigators retrospectively assessed independent data on 6,756 patients who underwent a comprehensive TTE at Mayo Clinic in Rochester, Minnesota, between January 2009 and December 2020. It was then independently tested in geographically distinct areas within Mayo Clinic Enterprise sites across the United States on a dataset that included 1,284 patients.The authors concluded, “EchoGo® Heart Failure’s exceptional discrimination capabilities, combined with its ability to identify patients with higher mortality risks, hold great promise for improving patient outcomes and enabling faster access to treatment.”References:1. Borlaug et al., Heart Failure With Preserved Ejection Fraction: JACC Scientific Statement. J Am Coll Cardiol 2023;81:1810–1834.2. Ultromics receives FDA Clearance for its Breakthrough Device EchoGo Heart Failure: An AI-based platform that enables precision detection of heart failure with preserved ejection fraction. News release. Ultromics. December 2, 2022.3. Akerman AP, et al. Automated Echocardiographic Detection of Heart Failure with Preserved Ejection Fraction Using Artificial Intelligence. JACC Adv. 2023:1;2(6):100452–2.About Ultromics:Ultromics is a pioneer in precision heart failure detection. Our ground-breaking platform, EchoGo®, is transforming the way heart failure is diagnosed using artificial intelligence and cardiac ultrasound as a modality.  The technology empowers clinicians to make precise, efficient, and accurate assessments of heart failure, leveraging the largest known heart disease dataset in echocardiography. The model was trained on thousands of patients to accurately detect disease and was validated against 5-year patient outcomes.  The technology has been built in collaboration with Mayo Clinic and the NHS England. Ultromics’ mission is to stop heart failure in its tracks with its precision detection platform.Photo – https://mma.prnewswire.com/media/2452704/Ultromics.jpgSOURCE Ultromics

Pulnovo Medical Announces First Enrollment in Portugal for Global Clinical Study of PADN Technology in Treating Pulmonary Hypertension Associated with Left Heart Disease

SHANGHAI, July 2, 2024 /PRNewswire/ — Pulnovo Medical Limited, a globally recognized device pioneer in the treatment of Pulmonary Hypertension (PH) and Heart Failure (HF), is pleased to announce the successful initiation and first two patients enrollment for its global multicenter clinical study exploring the percutaneous pulmonary artery denervation (PADN) treatment for pulmonary hypertension associated with left heart disease. This landmark event took place at Centro Hospitalar Universitário de Lisboa Central – Hospital de Santa Marta in Portugal, marking the beginning of Pulnovo Medical’s innovative product deployment on a global scale.
Under the guidance of Professor Hang Zhang from Nanjing Medical University Affiliated Nanjing Hospital, Prof. Ruben Ramos and his team successfully performed the PADN procedure on two patients. The procedure was smooth, the devices easy to operate, and the results were excellent. The Portuguese medical team was impressed by the PADN technology’s safety and efficacy, as demonstrated by many years of data. Clinical parameters showed promising results when using PADN technology. The products’ comprehensive design and high-precision algorithm control significantly ensured stable energy output and effective surgical results.
Prof. Ruben Ramos said, “PADN technology shows great potential in treating pulmonary hypertension associated with left heart disease. We are delighted to be the first in Europe to participate in this global clinical study. Our team is confident in this project and looks forward to bringing more treatment options to European pulmonary hypertension patients through this study. PADN is not only a new treatment method but also brings new hope to patients suffering from pulmonary hypertension.”
Jessie Lian,Pulnovo Medical’s CEO said, “The PADN global multicenter clinical study is one of our key projects dedicated to innovative treatment technologies in the cardiovascular field. As an emerging treatment, PADN has enormous potential and prospects. The post-operative results of the first overseas application of PADN reflect the academic borderlessness of the moment. In the future, we will continue to firmly advance our global business, steadily promoting the teaching and learning of PADN technology. ”
Cynthia Chen, Pulnovo Medical’s Chairlady said, “We are proud to have successfully completed the first enrollment in the European multicenter clinical study of PADN in Portugal, marking the acceleration of our technology’s global progress. We will continue to promote the global application of PADN, allowing more patients to benefit from this innovative therapy.”

Anteris Technologies and v2vmedtech Announce Concept Lock of Next Generation Mitral and Tricuspid Repair System as VClip™ Passes Animal Study

VClip™ restores mitral valve function and overcomes limitations of current technologies July 01, 2024 05:30 AM Eastern Daylight Time BRISBANE, Australia & EAGAN, Minn.–(BUSINESS WIRE)–Anteris Technologies Ltd (ASX: AVR), a structural heart company developing DurAVR™ THV, a new class of TAVR and the world’s only balloon-expandable, single-piece biomimetic aortic replacement valve […]

Merck Receives Positive EU CHMP Opinion for WINREVAIR™ (sotatercept) in Pulmonary Arterial Hypertension (PAH)

If approved by the European Commission, WINREVAIR will be the first activin signaling inhibitor therapy for PAH in Europe, offering a new treatment option for certain adults with this rare, progressive disease Milestone highlights Merck’s focus on global filings to expand access to WINREVAIR and commitment to patients living with […]

Fort Sanders Regional Medical Center First in Tennessee to Adopt New Cardiac Angiogram Technology

KNOXVILLE, Tenn., June 26, 2024 /PRNewswire/ — Fort Sanders Regional Medical Center, a member of Knoxville-based Covenant Health, was the first hospital in the state of Tennessee to adopt revolutionary diagnostic technology that provides clinicians with a patient’s physiology results in just a few minutes.
Coronary heart disease is one of the top killers of adults in the U.S. and particularly the Southeast. Quick diagnosis and intervention are key to treating cardiac patients who are suffering from heart disease, heart attack, or other events causing blockages in arteries that can be life-threatening.
Fort Sanders Regional’s cardiac catheterization lab is staffed around the clock, 24/7, treating both heart patients who have been admitted to the hospital and those who are having outpatient procedures.
When a patient presents with a potential artery blockage, the heart team at Fort Sanders Regional can use a new tool that shows doctors exactly what percentage of an artery is blocked. The CathWorks FFRangio ® System is a computer-based technology that uses routine angiograms (images) of a patient’s heart structure to create a 3D model showing the location and degree of any blockages and their coronary arteries. This helps providers more quickly diagnose and intervene as needed, including determining whether the patient needs a stent and where the stent should be placed in the heart structure.
Fractional flow reserve (FFR) is a diagnostic measurement that evaluates the physiologic impact of coronary artery narrowing due to cholesterol plaque. It is an important part of the decision-making process to decide if a stent placement is indicated and the length of the stent when managing patients with coronary artery disease (CAD).
In contrast to traditional FFR, the FFRangio System combines artificial intelligence (AI) and advanced computational science to obtain quick and reliable FFRangio values from routine angiograms, eliminating the need for drug stimulation and invasive pressure wires. The system provides physicians intraprocedural FFRangio values for all coronary arteries.
Josh Todd, MD, interventional cardiologist at Fort Sanders Regional, said, “With this new tool, interventional cardiologists can perform clinical assessments quicker, more comprehensively, without medications, and in a way that’s seamless and more efficient to the patient. This cutting-edge technology will transform how cardiovascular disease is diagnosed and treated.”
To view the full release, visit https://www.covenanthealth.com/blog/cathworks-technology/.
SOURCE Covenant Health

Rivus Pharmaceuticals Announces Publication of Phase 2a HuMAIN Trial Rationale and Design in European Journal of Heart Failure

– Study evaluating HU6 in patients with obesity-related heart failure with preserved ejection fraction is on track to report topline data in the second half of 2024 –
– HU6, a novel Controlled Metabolic Accelerator, is a new class of investigational medicines designed to reduce weight while preserving muscle –
CHARLOTTESVILLE, Va. and SAN FRANCISCO, June 26, 2024 /PRNewswire/ — Rivus Pharmaceuticals Inc., a clinical-stage biopharmaceutical company dedicated to improving metabolic health, today announced publication of the rationale and design of the company’s Phase 2a HuMAIN trial in the European Journal of Heart Failure. Rivus has completed patient enrollment in this clinical trial of HU6, an investigational Controlled Metabolic Accelerator (CMA), in patients with obesity-related heart failure with preserved ejection fraction (HFpEF) and expects to report topline data in the second half of 2024.
“HuMAIN is the first clinical trial to evaluate the effects of a CMA in patients with obesity-related HFpEF, who have a median survival rate of around two years following hospitalization,” said Jayson Dallas, M.D., chief executive officer, Rivus Pharmaceuticals. “HU6 has the potential to be the first disease-modifying treatment for HFpEF. We look forward to further evaluating the potential benefits of HU6 in this large and growing patient population and sharing topline results in the second half of 2024.”
HFpEF is a chronic debilitating syndrome characterized by severely reduced exercise capacity, which degrades quality of life. Obesity is a major independent risk factor for HFpEF and key contributor to the increasing worldwide prevalence of this disorder, with as many as 80% of patients with HFpEF in Western countries either overweight or obese. Weight loss approaches that involve dieting, bariatric surgery and GLP-1 agonists work by decreasing energy intake rather than by increasing energy expenditure. In addition to loss of fat, these approaches result in marked reductions in muscle mass, which can lead to impaired function in patients with HFpEF, who are typically elderly and frail and already have reduced muscle mass.
“Given the limitations of current options for patients with obesity-related HFpEF, novel disease-modifying treatments are urgently needed,” said Dalane W. Kitzman, M.D., lead author of the publication and professor of internal medicine and cardiovascular medicine at Wake Forest University School of Medicine. “As detailed in this new publication, HU6 reduces fat, which is pivotal to the development of HFpEF, by increasing energy expenditure while preserving muscle. The Phase 2a trial will examine HU6’s potential to improve key outcomes in HFpEF, including increasing exercise capacity and quality of life, reducing systemic inflammation, and improving blood pressure and glucose metabolism.”
About the Phase 2a HuMAIN TrialThe randomized, double-blind, placebo-controlled, parallel-group, dose-escalation Phase 2a HuMAIN study (ClinicalTrials.gov: NCT05284617) is evaluating the safety, tolerability, pharmacodynamics and pharmacokinetics of ascending doses of HU6 (150 mg, 300 mg, 450 mg daily) in patients with obesity-related HFpEF. A total of 65 study participants (37 women and 28 men) age 30 or older with a body mass index (BMI)  >30 kg/m2 were randomized to 134 days of daily dosing with HU6 or placebo.
The primary efficacy endpoint is weight reduction (as measured by the change from baseline in body weight at Day 134). The key secondary efficacy endpoint is exercise capacity (as measured by the change from baseline in peak VO2 [mL/kg/min] during a standardized, noninvasive cardiopulmonary exercise test at Day 134). The effects of HU6 on disease-specific quality of life, changes in body composition and cardiac function/structure, and markers of cardiometabolic dysfunction (e.g., changes in blood pressure and pulse, glucose control, inflammation, lipid levels and liver fat and liver enzymes) are also being evaluated. The study is designed to identify the optimal dose of HU6 for Phase 3 trials. HuMAIN is being conducted at 22 clinical sites in the United States.
About Controlled Metabolic Accelerators (CMAs)Rivus is advancing a new class of investigational medicines called Controlled Metabolic Accelerators (CMAs) that have the potential to improve metabolic health for people with obesity and associated metabolic diseases. CMAs are oral small molecules designed to increase resting metabolic rate, which results in increased consumption of energy, primarily from fat. The loss in fat mass addresses multiple cardiometabolic conditions driven by adiposity. CMAs increase metabolism in a continuous and imperceptible manner by leveraging the natural metabolic process of mitochondrial uncoupling. Uncoupling accounts for 20%-40% of resting caloric consumption. A key advantage of this mechanism for increasing energy expenditure is that the resulting weight loss is fat selective with preservation of muscle mass. In contrast, caloric-restriction strategies reduce energy input and result in loss of fat as well as muscle mass. Initial data in humans has demonstrated that CMAs provide fat-selective weight loss, improved insulin sensitivity, and a significant reduction in oxidative stress and inflammation.
About HU6HU6, an oral, once-daily investigational medicine, is Rivus’ lead CMA. It is a purposely designed investigational oral small molecule that is intended to be a foundational monotherapy for cardiac, liver, diabetes and obesity indications. HU6 promotes sustained weight loss by gently, safely and imperceptibly increasing resting metabolism, which results in fat burn, while preserving muscle mass. Phase 2 results in patients with a high body mass index (BMI) and metabolic dysfunction-associated steatotic liver disease (MASLD) showed that once-daily HU6 significantly reduced liver fat content and body weight with no loss of lean muscle mass and improved key markers of systemic inflammation and metabolism.1 HU6 was well tolerated; side effects were mainly mild or moderate in severity.
The current clinical development of HU6 is focused on metabolic diseases with the most morbidity and greatest treatment needs: heart failure with preserved ejection fraction (HFpEF) and metabolic dysfunction-associated steatohepatitis (MASH)/MASLD.
About Rivus PharmaceuticalsRivus Pharmaceuticals, Inc., a leader in mitochondrial biology, is dedicated to improving metabolic health by advancing a new class of investigational medicines called Controlled Metabolic Accelerators (CMAs). Rivus’ lead CMA is the investigational small molecule HU6 in development to treat heart failure with preserved ejection fraction (HFpEF), metabolic dysfunction-associated steatotic liver disease (MASLD)/metabolic dysfunction-associated steatohepatitis (MASH) and Type 2 diabetes. For more information, please visit www.rivuspharma.com.
Contact:Meredith MallenReal Chemistry[email protected]+1-516-987-2313
References

Noureddin M, Khan S, Portell F, et al. Safety and efficacy of once-daily HU6 versus placebo in people with non-alcoholic fatty liver disease and high BMI: a randomised, double-blind, placebo-controlled phase 2a trial. Lancet Gastroenterol Hepatol. 2023.

SOURCE Rivus Pharmaceuticals

Alnylam Reports Positive Topline Results from HELIOS-B Phase 3 Study of Vutrisiran, Achieving Statistical Significance on Primary and All Secondary Endpoints in Both Overall and Monotherapy Populations

June 24, 2024 07:00 AM Eastern Daylight Time CAMBRIDGE, Mass.–(BUSINESS WIRE)–Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced positive topline results from its HELIOS-B Phase 3 study of vutrisiran, an investigational RNAi therapeutic in development for the treatment of ATTR amyloidosis with cardiomyopathy (ATTR-CM). Alnylam Reports Positive […]

MemorialCare Heart & Vascular Institute at Long Beach Medical Center is First Hospital in Southern California to Perform Transcatheter Aortic Valve Implantation with Navitor Titon 35mm Valve

This is the first 35mm size valve implantation giving those with large native aortic valves at high-risk a minimally invasive option – avoiding open heart surgeryLONG BEACH, Calif., June 21, 2024  /PRNewswire/ — Yesterday, MemorialCare Heart & Vascular Institute at Long Beach Medical Center was the first hospital in Southern California to implant a 35mm Abbott Titan Navitor Valve during a Transcatheter Aortic Valve Implantation (TAVI) procedure. The TAVI procedure is crucial for patients who have severe aortic stenosis and are at extreme risk for open-heart surgery. This offers a minimally invasive approach which shortens hospital stays, reduces risk of infection and lessens recovery time.

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Titan Navitor Valve Team from MemorialCare Heart and Vascular Institute at Long Beach Medical Center

“We are very proud of Dr. Anthony Chyou and Dr. Ali Khoynezhad for leading us through this transformational time of our heart and vascular institute,” says David Shavelle, M.D., FACC, chief of cardiology, MemorialCare Heart & Vascular Institute; medical director, adult cardiology & interventional lab, MemorialCare Heart & Vascular Institute at Long Beach Medical Center. “We have always taken pride in creating an environment where our patients are given personalized treatment. The Navitor Titan 35mm Valve allowed us to provide a minimally invasive treatment option to a high-risk patient with severe aortic stenosis.”

The Navitor valve is one of the newest heart valve devices approved by the U.S. Food and Drug Administration for TAVI, also known as Transcatheter Aortic Valve Replacement (TAVR). This device is different from other heart valve replacement valves on the market due to improved blood flow (hemodynamic) performance and ease of use.
“The intuitive design of the Navitor TAVI System allows more patients who normally would not be viable candidates for a Transcatheter Aortic Valve Replacement procedure access to a valve replacement,” says Optum partnering physician Anthony Chyou, M.D., who is also an interventional cardiologist at MemorialCare Heart & Vascular Institute at Long Beach Medical Center. “Patients with large native aortic valves and severe aortic stenosis valve disease may not have been able to receive treatment as prior TAVI valves were not large enough to accommodate their anatomy.”Heart valve disease limits the ability of the heart to pump blood through the entire body. The Navitor TAVI System has been tested and shown to greatly improve the blood flow of patients with symptomatic severe aortic stenosis, helping their hearts resume to normal, healthy blood flow performance quickly.”MemorialCare is dedicated to state-of-the-art, patient-centric care to our community, and this ‘first in the region’ procedure is a testament to our continued commitment to excellent patient care,” says Ali Khoynezhad, M.D., director, aortic and arrythmia surgery, MemorialCare Heart & Vascular Institute at Long Beach Medical Center.The Navitor TAVI System has been rigorously tested and proven to yield positive 30-day outcomes in patients with symptomatic severe aortic stenosis, including a 0% chance of moderate or severe paravalvular leak (PVL), 1.9% chance of all-cause mortality, 1.9% chance of disabling stroke, and 4.2% chance of major vascular complications, proving its remarkable safety and effectiveness in TAVR procedures.About MemorialCare Long Beach Medical Center:MemorialCare Long Beach Medical Center is a member of MemorialCare, a not-for-profit, integrated healthcare system. Long Beach Medical Center has been providing the community with compassionate, quality health care for more than 100 years. At the forefront of specialized care, research, and education, Long Beach Medical Center uses the most advanced healthcare technologies, including pioneering surgical systems like – ExactechGPS® and ExcelsiusGPS®. Recognized among the top 3% of all California acute care hospitals, Long Beach Medical Center is recognized as “Best Hospital” for OBGYN and Orthopedics and ranked regionally in the Los Angeles Metro Area by U.S. News & World Report and earned Magnet® recognition for nursing excellence. With premier centers dedicated to cancer, heart, rehabilitation, orthopedics, neurosciences, and trauma, physicians and surrounding hospitals continually refer to its accredited programs. For more information, visit memorialcare.org/LongBeach.SOURCE MemorialCare Long Beach Medical Center