The Latest Cardiac and Vascular News
Other new investors include Viking Global Investors and RA Capital Management Funding will support Magenta’s clinical programs in support of FDA approval for Elevate, the world’s smallest heart pump KADIMA, Israel, July 23, 2024 /PRNewswire/ — Magenta Medical, developer of Elevate™, the world’s smallest heart pump, has closed a $105M financing round led by global healthcare […]
Multi-center, Retrospective Trial to Assess Prognostic Accuracy of Elucid’s Plaque and Plaque-based FFRCT Software in Patients with Clinically Indicated CCTA July 18, 2024 07:05 AM Eastern Daylight Time WASHINGTON & BOSTON–(BUSINESS WIRE)–SCCT2024 – Elucid, a pioneering AI medical technology company providing physicians with imaging analysis software based on ground truth histology to support […]
Technology offers benefits of HeartFlow Plaque Analysis with the new addition of 3D interactive capabilities, integrated with lesion specific FFRCT values
WASHINGTON, July 18, 2024 /PRNewswire/ — The Heart Failure Society of America (HFSA) recently announced the selection of new officers and board members for the society with terms starting at the conclusion of the HFSA Annual Scientific Meeting 2024 (ASM), which will take place September…
— Portuguese Ministry of Health approves VAZKEPA® (icosapent ethyl) for national reimbursement to reduce the risk of cardiovascular (CV) events in patients with established cardiovascular disease (CVD)1 — — Approval marks eighth national reimbursement of VAZKEPA® in Europe —
SUNNYVALE, Calif., July 17, 2024 (GLOBE NEWSWIRE) — BioCardia, Inc. [Nasdaq: BCDA], a company focused on cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases today announces that the Unites States Patent Office has granted Patent No: 12,036,371 titled “Method of Accessing the Left Atrium with a Multi-Directional Steerable Catheter,” with a patent term that will expire in 2035. The present invention relates to medical methods for transseptal access to the heart using steerable introducers based on the Company’s Morph DNA technology. This additional patent protection for BioCardia’s current and future products in this important existing market enhances shareholder value. Procedures that leverage transseptal delivery include atrial fibrillation ablation, patent foramen ovale (PFO) and atrial septal defect (ASD) repair, percutaneous mitral valve repair, left atrial appendage closure, and percutaneous left ventricular assist device placement, among others. Worldwide revenue from the transseptal access systems market was $941.3 million in 2022, with the global market estimated to expand at a Compound Annual Growth Rate of 7.3%, reaching $2.1 billion by the end of 2033(1). Morph DNA designs enable the tensioning elements in the catheter to rotate around the catheter shaft, allowing consistent catheter performance in any direction. The DNA name reflects this design, as these tensioning elements appear as a double helix like that in a strand of DNA. This design is intended to enable smooth navigation and prevent “whip,” when the build-up of mechanical forces in the device causes a catheter to suddenly jump from one orientation to another. “All of the biotherapeutic interventions we support for treatment of heart failure, refractory angina, and acute myocardial infarction going forward are expected to utilize this same introducer technology platform,” said Peter Altman, PhD, BioCardia’s President and Chief Executive Officer. “This is an elegant solution to a long-standing technical issue. The solution enhances the level of physician control in our procedures, and BioCardia is working to provide or partner this solution for the roughly five hundred thousand transseptal procedures performed in the United States each year, and for other vascular access markets that can benefit from the advantages our patented solution provides.” About BioCardia® BioCardia, Inc., headquartered in Sunnyvale, California, is developing cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease. CardiAMP® autologous and CardiALLO™ allogeneic cell therapies are the Company’s biotherapeutic platforms with three clinical stage product candidates in development. These therapies are enabled by its Helix biotherapeutic delivery and Morph vascular navigation product platforms. For more information visit: www.BioCardia.com. Forward Looking Statements: This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include, among other things, references to the Company’s investigational product candidates, the advantages of the Morph DNA design, and the potential transseptal access delivery vascular market for the Morph DNA steerable introducer product Family. These forward-looking statements are made as of the date of this press release, and BioCardia assumes no obligation to update the forward-looking statements. We may use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey the uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results may differ materially from the forward-looking statements contained in this press release. As a result of these factors, we cannot assure you that the forward-looking statements in this press release will prove to be accurate. Additional factors that could materially affect actual results can be found in BioCardia’s Form 10-K filed with the Securities and Exchange Commission on March 27, 2024, under the caption titled “Risk Factors” and in its subsequently filed Quarterly Reports on Form 10-Q. BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law. (1) Persistence Market Research (2022). “Transseptal Access Systems Market Outlook (2023-2033).” New York, NY. Persistence Market Research Pvt. Ltd.
WELL has launched its new AI-powered physician co-pilot to assist cardiologists in better identifying patients at high risk of cardiovascular disease (“CVD”). WELL is exclusively partnering with HEALWELL AI, a leader in AI enabled disease diagnosis, as an extension of the WELL AI Decision Support (“WAIDS”) product offering.
The co-pilot will be deployed into WELL Diagnostic Centres, Canada’s largest cardiology and medical diagnostic group, providing support and assisting cardiologists in over 40 locations across Ontario.
CVD stands as the leading cause of death globally, accounting for approximately 32% of deaths worldwide in 2019(1), underscoring the critical need for early detection. HEALWELL also expects to leverage this technology to help accelerate life sciences research and development opportunities related to CVD and drive new business opportunities for its newly acquired Clinical Research Organization (“CRO”), BioPharma Services Inc.
VANCOUVER, BC and TORONTO, July 17, 2024 /PRNewswire/ – WELL Health Technologies Corp. (TSX: WELL) (OTCQX: WHTCF) (“WELL” or the “Company”) a digital health company focused on tech-enabling healthcare providers, and its investee company, HEALWELL AI Inc. (TSX: AIDX) (OTCQX: HWAIF) (“HEALWELL”), a healthcare technology company focused on AI and data science for preventative care, are jointly pleased to announce the launch of WELL’s AI-powered co-pilot for cardiologists exclusively powered by HEALWELL AI, aimed at identifying patients at high risk of cardiovascular disease (“CVD”). This significant expansion of WELL’s AI capabilities builds on the success of its second-generation AI-powered physician co-pilot, WELL AI Decision Support (“WAIDS”), developed exclusively in partnership with HEALWELL. This enhancement adds to its existing rare and chronic disease detection abilities and is an extension to the WAIDS offering.
The co-pilot for cardiologists will be deployed in WELL Diagnostics Centres, Canada’s largest cardiology and medical diagnostic group with over 40 locations in Ontario. It will be available to cardiologists within the WELL Diagnostic Centres ecosystem, providing invaluable support in the early detection and management of cardiovascular disease.
Dina Sergi, CEO of WELL Diagnostic Centres, highlighted the tool’s impact, “The integration of HEALWELL’s AI-powered co-pilot for cardiologists into our WELL Diagnostic Centres represents a game-changing advancement. By offering precise risk stratification and actionable insights, this tool enhances their ability to proactively manage cardiovascular health and improve patient care.”
Dr. Alexander Dobranowski, CEO of HEALWELL, commented, “The launch of our AI-powered co-pilot for specialists marks a significant milestone in our mission to enhance healthcare through advanced technology. By expanding our AI capabilities to include cardiovascular disease detection, we are equipping cardiologists with enhanced tools and decision support necessary to identify at-risk patients earlier, ultimately improving patient outcomes and reducing healthcare costs. The integration of this tool into WELL’s Diagnostic Centres is particularly important, as it provides us access to Canada’s largest cardiology group. This vast dataset not only assists hundreds of cardiologists within the WELL Diagnostic Centres ecosystem but also allows us to continuously refine and enhance the co-pilot.”
Dr. Paul Kannampuzha, Chief Cardiology Officer of WELL Diagnostic Centres commented. “As a cardiologist, I am encouraged by how AI can help provide improved disease detection and decision support for cardiologists across the country. I believe this technology will help drive improved preventative care and ensure patients don’t fall through the cracks.”
Cardiovascular disease (CVD) is a group of disorders affecting the heart and blood vessels and is the leading cause of death globally, responsible for approximately 32% of deaths worldwide in 2019(1). In Canada, recent estimates suggest that CVD costs about $22 billion per year and is considered the second leading contributor to healthcare costs(2). Identifying patients with worsening cardiovascular conditions earlier is crucial, as cardiovascular disease is the third leading cause of death in Canada.
The global market for pharmaceutical drugs supporting cardiovascular disease was valued at approximately USD 144.1 billion in 2023. It is projected to grow at a compound annual growth rate (CAGR) of approximately 4% over the next decade, reaching an estimated USD 207.8 billion by 2033 (Precedence Research)(3). HEALWELL expects to leverage this technology to help accelerate life sciences research and development opportunities related to CVD and drive new business opportunities for its newly acquired Clinical Research Organization (CRO), BioPharma Services Inc.
Footnotes:
https://www.who.int/news-room/fact-sheets/detail/cardiovascular-diseases-%28cvds%29
https://link.springer.com/article/10.1007/s41669-021-00257-8
https://www.precedenceresearch.com/cardiovascular-drugs-market
About WELL Health Technologies Corp.
WELL’s mission is to tech-enable healthcare providers. We do this by developing the best technologies, services, and support available, which ensures healthcare providers are empowered to positively impact patient outcomes. WELL’s comprehensive healthcare and digital platform includes extensive front and back-office management software applications that help physicians run and secure their practices. WELL’s solutions enable more than 34,000 healthcare providers between the US and Canada and power the largest owned and operated healthcare ecosystem in Canada with more than 175 clinics supporting primary care, specialized care, and diagnostic services. In the United States WELL’s solutions are focused on specialized markets such as the gastrointestinal market, women’s health, primary care, and mental health. WELL is publicly traded on the Toronto Stock Exchange under the symbol “WELL” and on the OTC Exchange under the symbol “WHTCF”. To learn more about WELL, please visit: www.well.company.
About HEALWELL AI
HEALWELL is a healthcare technology company focused on AI and data science for preventative care. Its mission is to improve healthcare and save lives through early identification and detection of disease. Using its own proprietary AI technology and competencies which includes data science, electronic health records and clinical research offerings, the Company is developing and commercializing advanced clinical decision support systems that can help healthcare providers detect rare and chronic diseases, improve efficiency of their practice and ultimately help improve patient health outcomes. HEALWELL is publicly traded on the Toronto Stock Exchange under the symbol “AIDX” and on the OTC Exchange under the symbol “HWAIF”. To learn more about HEALWELL, please visit https://healwell.ai/.
Forward-Looking Statements
Certain statements in this press release, constitute “forward-looking information” and “forward looking statements” (collectively, “forward looking statements”) within the meaning of applicable Canadian securities laws and are based on assumptions, expectations, estimates and projections as of the date of this press release. Forward-looking statements in this press release include statements with respect to, among other things, the deployment of WAIDS at WELL Health Diagnostic Centres, the use of the WAIDS to improve patient care, and the use of AI technology by HEALWELL to drive research and development opportunities related to CVD. Forward-looking statements are often, but not always, identified by words or phrases such as “opportunity”, “potential”, “improve”, “expect”, “intend”, “create” or variations of such words and phrases or statements that certain future conditions, actions, events or results “will”, “may”, “could”, “would”, “should”, “might” or “can” be taken, occur or be achieved, or the negative of any of these terms . Forward-looking statements are necessarily based upon management’s perceptions of historical trends, current conditions and expected future developments, as well as a number of specific factors and assumptions that, while considered reasonable by HEALWELL as of the date of such statements, are outside of HEALWELL’s control and are inherently subject to significant business, economic and competitive uncertainties and contingencies which could result in the forward-looking statements ultimately being entirely or partially incorrect or untrue. Forward looking statements contained in this press release are based on various assumptions, including, but not limited to: the ability of HEALWELL to utilize AI technologies to detect CVD indicators; the ability to collaborate with the pharmaceutical industry for research and development opportunities, HEALWELL’s continued compliance with third party intellectual property rights; HEALWELL’s continued compliance with privacy laws; and that the risk factors noted below, collectively, do not have a material impact on HEALWELL’s business, operations, revenues and/or results. By their nature, forward-looking statements are subject to inherent risks and uncertainties that may be general or specific and which give rise to the possibility that expectations, forecasts, predictions, projections, or conclusions will not prove to be accurate, that assumptions may not be correct, and that objectives, strategic goals and priorities will not be achieved.
Known and unknown risk factors, many of which are beyond the control of HEALWELL, could cause the actual results of HEALWELL to differ materially from the results, performance, achievements, or developments expressed or implied by such forward-looking statements. Such risk factors include but are not limited to those factors which are discussed under the section entitled “Risk Factors” in HEALWELL’s most recent annual information form dated April 1, 2024, which is available under HEALWELL’s SEDAR+ profile at www.sedarplus.com. The risk factors are not intended to represent a complete list of the factors that could affect HEALWELL and the reader is cautioned to consider these and other factors, uncertainties and potential events carefully and not to put undue reliance on forward-looking statements. There can be no assurance that forward looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Forward-looking statements are provided for the purpose of providing information about management’s expectations and plans relating to the future. HEALWELL disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise, or to explain any material difference between subsequent actual events and such forward-looking statements, except to the extent required by applicable law. All of the forward-looking statements contained in this press release are qualified by these cautionary statements.
SOURCE WELL Health Technologies Corp.
SEATTLE, July 16, 2024 (GLOBE NEWSWIRE) — Faraday Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company focused on the prevention of heart failure by reducing myocardial damage following acute ST-elevation myocardial infarction (STEMI) through the reduction of reperfusion injury during percutaneous coronary intervention (PCI), today announced it will host a virtual KOL webinar on Tuesday, July 30, 2024, at 11:00 AM ET. To register for the webinar, click here. The webinar will feature Dr. Cheerag Shirodaria (Oxford University Hospitals), Dr. Marc Bonaca (University of Colorado Anschutz), and Dr. Antonio Gutierrez (Duke University Hospital and Durham VA Medical Center), who will discuss the unmet need and current treatment landscape in preventing ischemia-reperfusion injury and highlight the effects of STEMI on heart failure and other patient outcomes. The webinar will also review data from the development of FDY-5301, an investigational product being evaluated by Faraday in minimizing cardiac damage following acute STEMI. The company’s pivotal Phase 3 Iocyte AMI-3 trial of FDY-5301 in anterior STEMI patients undergoing primary percutaneous intervention is now fully enrolled with topline data anticipated in 2H 2025. A live question and answer session will follow the formal presentations. About Cheerag Shirodaria, BSc, MBBS, MD, FRCP, MBA Dr. Cheerag Shirodaria is Chief Development Officer at Caristo Diagnostics and a Cardiologist at Oxford University Hospitals in the UK. He is an interventional cardiologist who is also an expert in cardiac imaging, particularly cardiac MRI (CMR) and coronary CT angiography (CCTA), having completed his doctoral thesis in Oxford on novel vascular imaging techniques using CMR. He was heavily involved in the design and execution of the phase 2 STEMI trial involving FDY-5301 and is a member of the Executive Steering Committee of the IOCYTE-AMI trial. As co-founder and former CEO of Caristo, he has developed and commercialized novel imaging AI imaging tools to predict future cardiometabolic risk. Dr Shirodaria obtained his medical degree from St Bartholomew’s Hospital Medical College, his medical doctorate from the University of Oxford and his MBA from London Business School. About Marc Bonaca, MD, MPH Dr. Marc Bonaca is a cardiologist and vascular medicine specialist serving as executive director of CPC and Director of Vascular Research & Professor of Medicine at the University of Colorado Anschutz. Dr. Bonaca earned his medical degree from the University of Connecticut and his MPH at Harvard. He completed his medical residency, cardiology fellowship, and vascular medicine fellowship at Brigham and Women’s Hospital and a dedicated research fellowship at the TIMI Study Group. He became faculty at BWH and Harvard Medical School and an investigator at TIMI. He directed pharmacovigilance at TIMI and was an investigator on several large outcomes trials including TRA2P-TIMI 50, PEGASUS-TIMI 54, DECLARE-TIMI 58, and REAL TIMI 63B. In 2018, he joined the faculty at the University of Colorado as Professor of Medicine and the William R. Hiatt Endowed Chair in Cardiovascular Research. He is the Executive Director of CPC, an affiliated non-profit Academic Research Organization. At CPC, he has led several clinical trials with CPC as the lead ARO, including VOYAGER PAD, PREVENT HD, and ASPEN, and is leading several ongoing trials, including BRIGHT and EVOLVE MI, a 4000-patient pragmatic multinational acute coronary syndrome trial. Dr. Bonaca’s research focus is on ischemic risk with atherosclerotic vascular disease, risk prediction, and risk modification using pharmacologic and biologic therapies. He has extensive experience designing and conducting large, multicenter randomized clinical trials, and analyzing registries and real-world datasets. His areas of interest include PAD, PVD, and diabetes, with a focus on the breadth of risk including ischemic limb outcomes, microvascular complications, and major adverse cardiovascular events. He is also investigating the cardiac, vascular, and thrombotic complications associated with novel oncologic therapies. At CPC, he has focused on building a robust faculty and operational group dedicated to high quality, efficient trials leveraging health networks, informatics, and decentralized design. About J. Antonio T. Gutierrez, MD Dr. Antonio Gutierrez’s clinical interests include diagnostic and interventional coronary angiography, peripheral angiography and percutaneous intervention, and vascular medicine. His research interests are focused on peripheral artery disease. He has been involved in multiple clinical trials involving patients with atherosclerotic disease and has published several peer-reviewed articles and reviews. Dr. Gutierrez received his Bachelor of Arts from the College of the Holy Cross in 2000, Doctorate of Medicine from Case Western Reserve University School of Medicine in 2007, and Masters of Health Science in Clinical Research from Duke University School of Medicine in 2012. He completed his residency in Internal Medicine at Duke University Medical Center in 2010 and was appointed Chief Medical Resident of the Durham VA Medical Center in 2011. Dr. Gutierrez completed his General Cardiology and Vascular Medicine Fellowships at Brigham and Women’s Hospital and a Clinical Research Fellowship at the TIMI Study Group. Most recently Dr. Gutierrez matriculated his Interventional Cardiology Fellowship at Duke University Medical Center. Dr. Gutierrez is currently an Assistant Professor of Medicine at Duke University Hospital and Staff Physician at the Durham VA Medical Center. About STEMI Acute STEMI is a leading cause of cardiovascular death and remains a primary cause of the development of heart failure. Standard treatment of a STEMI involves PCI, during which a catheter is inserted into the artery to remove the blockage and restore blood flow. Following a STEMI, one of the critical factors influencing patient outcomes is reperfusion injury, which occurs when the oxygen-rich blood supply returns to the ischemic heart muscle. About FDY-5301 FDY-5301 is an elemental reducing agent containing sodium iodide for which Faraday has obtained method of use patent protection in major markets worldwide. Faraday has selected FDY-5301 for investigation in the belief that its properties are well-suited to mitigate ischemia-reperfusion injury (IRI). In preclinical IRI models, FDY-5301 reduced tissue damage, infarct size, and inflammation. FDY-5301 functions as a catalytic neutralizer of hydrogen peroxide, a prominent reactive oxygen species implicated in the IRI cascade leading to cardiomyocyte death, and also acts as an immunomodulating agent. A Phase 2 clinical trial of FDY-5301 in STEMI patients demonstrated that it was well-tolerated and provided encouraging signals of potential efficacy in minimizing cardiac damage. Results from that trial — known as Iocyte AMI — were reported in the January 15, 2022, issue of the International Journal of Cardiology. About Faraday Pharmaceuticals, Inc. Faraday Pharmaceuticals® is a clinical-stage biopharmaceutical company focused on the prevention of heart failure by reducing myocardial damage in acute STEMI. The company was founded by Dr. Mark Roth of the Fred Hutch Cancer Center and is backed by an investor group led by ARCH Venture Partners and Polaris Partners. The company’s lead program, FDY-5301, is in a pivotal Phase 3 trial and is designed to reduce IRI in acute STEMI, a leading cause of death and a primary cause of the development of heart failure. The company is headquartered in Seattle. For more information, visit www.faradaypharma.com or follow the company on LinkedIn. Contact:Brian BlackmanChief Financial Officerbblackman@faradaypharma.com Contact:PJ KelleherLifeSci Advisors, LLC+1-617-430-7579pkelleher@lifesciadvisors.com
MOUNTAIN VIEW, Calif., July 16, 2024 (GLOBE NEWSWIRE) — HeartFlow, a leader in non-invasive artificial intelligence (AI) heart care solutions, today announced it will be presenting new findings on the use of coronary computed tomography angiography (coronary CTA) in coronary artery disease (CAD) management and insights on CTA reimbursement at the upcoming 19th Annual Scientific Meeting of SCCT. The annual meeting will take place on July 18-21, 2024 in Washington, D.C. Subset data from the PRECISE (Prospective Randomized Trial of the Optimal Evaluation of Cardiac Symptoms and Revascularization) Trial will also be presented. The PRECISE clinical trial data, originally presented in late 2022, confirmed CTA + FFRCT increases diagnostic accuracy, reduces unnecessary testing and offers higher confidence in identifying patients needing treatment versus traditional testing (stress nuclear, stress echo, and invasive coronary angiography). The new subset data analyzes the association between body mass index, testing performance and clinical outcomes in patients with stable chest pain. New insights from the ADVANCE Registry, including analysis on the relationship between risk factors and quantified atherosclerotic burden and differences in plaque quantification in a Japanese patient population will be shared. Along with the significant work HeartFlow has undertaken to develop age and sex specific nomograms, these data will be a pivotal step to better stratify patients and impact treatment decisions going forward. “The critical role of CTA in the diagnosis and management of coronary artery disease continues to drive every decision we make, ensuring the right patients are getting the right care at the right time,” said Campbell Rogers, Chief Medical Officer of HeartFlow. “This year, we are excited to share the latest insights on the importance of quantifying coronary artery plaque, as well as changes in the reimbursement landscape. We are pleased to continue providing robust clinical evidence as to how our products can help health care providers manage their patient’s heart health.” Details of the presentations are as follows: Session: Poster Session 8 – CT in Non-Acute Chest PainTitle: “Association Between Body Mass Index, Testing Performance And Clinical Outcomes In Patients With Stable Chest Pain: Insights From The PRECISE Trial”Date: Friday, July 19, 2024Time: 9:30 – 10:15 AM EDTLocation: Exhibit Hall Session: Poster Session 16 – Plaque ImagingTitle: The Relationship Of Risk Factors And Quantified Atherosclerotic Burden On Coronary Computed Tomographic Angiography – Lessons From The ADVANCE RegistryDate: Saturday, July 20 Time: 9:30 – 10:35 AM EDTLocation: Exhibit Hall Session: Poster Session 16 – Plaque ImagingTitle: Quantitative Differences Between Japanese And Non-Japanese Patients’ Coronary Computed Tomographic Angiography Derived Plaque – Insights From The ADVANCE RegistryDate: Saturday, July 20 Time: 9:30 – 10:35 AM EDTLocation: Exhibit Hall Session: Business Aspects of Cardiac CT – Part TwoTitle: “How clinicians can work with administrators to maximize cardiac CT reimbursement” Presenter: Cara SantilloDate: Thursday, July 18, 2024Time: 4:05 PM – 4:20 PM EDT Location: Liberty N-P Heartflow invites attendees to two sponsored events, including “Women in CT Happy Hour,” which will take place on July 18 from 6:00 PM – 7:00 PM EDT in the 2nd Floor Lobby, and “The Power of HeartFlow AI in the Management of CAD from Diagnosis to Treatment” symposium, which will take place on July 19 from 11:55 AM – 12:45 PM EDT in the Capitol/Congress Room. About HeartFlow, Inc.HeartFlow is transforming precision coronary care with the only AI-powered non-invasive integrated heart care solution across the CCTA pathway. As the pioneer of FFRCT, which is now supported by the ACC/AHA Chest Pain Guideline, HeartFlow continues to advance the diagnosis and management of CAD. HeartFlow’s suite of non-invasive technologies includes its FFRCT Analysis, RoadMap™Analysis, and Plaque Analysis. To date, more than 500 peer-reviewed publications have validated our approach and, more importantly, our technologies have helped clinicians diagnose and manage over 250,000 patients. For more information, visit www.heartflow.com. Media ContactLinly KuSr. Digital Marketing Managermedia@heartflow.com Investor ContactNick Laudico VP of Business Development and Investor Relationsnlaudico@heartflow.com
Late Breaking Clinical Trial Presentations to Feature Additional Results from SEQUOIA-HCM Related to Patient-Reported Health Status, Cardiac Structure and Function and Biomarkers Analyses of Safety and Outcomes from FOREST-HCM Related to Withdrawal of Standard of Care Medications to be Presented SOUTH SAN FRANCISCO, Calif., July 16, 2024 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) today announced seven upcoming presentations, including four Late Breaking Clinical Trial presentations related to aficamten, at the European Society of Cardiology Congress 2024, taking place in London, UK from August 30, 2024 – September 2, 2024. Late Breaking Clinical Trials Title: Effect of Aficamten on Patient-Reported Health Status in Obstructive Hypertrophic Cardiomyopathy: Results from SEQUOIA-HCMPresenter: John A. Spertus, M.D., M.P.H., Professor, Daniel J. Lauer Missouri Endowed Chair in Metabolic and Vascular Disease Research, Clinical Director, University of Missouri Kansas City Healthcare Institute for Innovations in Quality and Saint Luke’s Mid America Heart InstituteDate: September 1, 2024Topic: European Society of Cardiology Session Title: Trial Updates and Other Studies in Hypertrophic Cardiomyopathy and Aortic StenosisSession Type: Late-Breaking ScienceSession Time: 8:15-9:45 AM BSTPresentation Time: 8:15 AM BSTLocation: Bishkek Title: Impact of Aficamten on Echocardiographic Cardiac Structure and Function in Adults with Symptomatic Obstructive Hypertrophic CardiomyopathyPresenter: Sheila Hegde, M.D., M.P.H., Cardiovascular Medicine Specialist, Division of Cardiovascular Medicine, Brigham and Women’s HospitalDate: September 1, 2024Topic: European Society of Cardiology Session Title: Trial Updates and Other Studies in Hypertrophic Cardiomyopathy and Aortic StenosisSession Type: Late-Breaking ScienceSession Time: 8:15-9:45 AM BSTPresentation Time: 8:26 AM BSTLocation: Bishkek Title: Effect of Aficamten on Structure and Function in Patients with Obstructive Hypertrophic Cardiomyopathy: The SEQUOIA-HCM CMR SubstudyPresenter: Ahmad Masri, M.D., MS, Director of the Hypertrophic Cardiomyopathy Center at Oregon Health & Science UniversityDate: September 1, 2024Topic: European Society of Cardiology Session Title: Trial Updates and Other Studies in Hypertrophic Cardiomyopathy and Aortic StenosisSession Type: Late-Breaking ScienceSession Time: 8:15-9:45 AM BSTPresentation Time: 8:37 AM BSTLocation: Bishkek Title: Safety and Outcomes of Standard of Care Medications Withdrawal in Patients with Obstructive Hypertrophic Cardiomyopathy Treated with Aficamten in FOREST-HCM TrialPresenter: Ahmad Masri, M.D., MS, Director of the Hypertrophic Cardiomyopathy Center at Oregon Health & Science UniversityDate: September 1, 2024Topic: European Society of Cardiology Session Title: Trial Updates and Other Studies in Hypertrophic Cardiomyopathy and Aortic StenosisSession Type: Late-Breaking ScienceSession Time: 8:15-9:45 AM BSTPresentation Time: 8:48 AM BSTLocation: Bishkek Oral Presentations Title: Clinical Application of Biomarkers in Obstructive Hypertrophic Cardiomyopathy: Insights from SEQUOIA-HCMPresenter: Caroline Coats, M.D., Ph.D., Lead Clinician, West of Scotland Inherited Cardiac Conditions Service, Honorary Senior Lecturer, School of Cardiovascular and Metabolic Health, University of GlasgowDate: September 1, 2024Topic: Hypertrophic Cardiomyopathy Session Title: Novel Therapies for Hypertrophic Cardiomyopathy: Recent Developments and Future ProspectsSession Type: Advances in ScienceSession Time: 8:15-9:45 AM BSTPresentation Time: 8:51 AM BSTLocation: Dublin Title: Aficamten in Patients with Obstructive Hypertrophic Cardiomyopathy: An Integrated Safety AnalysisPresenter: Ahmad Masri, M.D., MS, Director of the Hypertrophic Cardiomyopathy Center at Oregon Health & Science UniversityDate: September 1, 2024Topic: Hypertrophic Cardiomyopathy Session Title: Novel Therapies for Hypertrophic Cardiomyopathy: Recent Developments and Future ProspectsSession Type: Advances in ScienceSession Time: 8:15-9:45 AM BSTPresentation Time: 9:09 AM BSTLocation: Dublin Moderated ePoster Title: Menopausal Status and Clinical Outcomes in Women with Heart Failure with Reduced Ejection Fraction: the GALACTIC-HF TrialPresenter: Maria A. Pabon, M.D., Instructor of Medicine, Brigham and Women’s Hospital, Harvard Medical School; Associate Director, Cardiac Imaging Core LabDate: September 2, 2024Topic: Cardiovascular Disease in Women Session Title: Cardiovascular Disease in WomenSession Type: Moderated ePostersSession Time: 9:00-9:50 AM BSTLocation: Station 6 About Cytokinetics Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle performance is compromised. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact myocardial muscle function and contractility. Cytokinetics is preparing for regulatory submissions for aficamten, its next-in-class cardiac myosin inhibitor, following positive results from SEQUOIA-HCM, the pivotal Phase 3 clinical trial in obstructive hypertrophic cardiomyopathy. Aficamten is also currently being evaluated in MAPLE-HCM, a Phase 3 clinical trial of aficamten as monotherapy compared to metoprolol as monotherapy in patients with obstructive HCM, ACACIA-HCM, a Phase 3 clinical trial of aficamten in patients with non-obstructive HCM, CEDAR-HCM, a clinical trial of aficamten in a pediatric population with obstructive HCM, and FOREST-HCM, an open-label extension clinical study of aficamten in patients with HCM. Cytokinetics is also developing omecamtiv mecarbil, a cardiac muscle activator, in patients with heart failure. Additionally, Cytokinetics is developing CK-586, a cardiac myosin inhibitor with a mechanism of action distinct from aficamten for the potential treatment of HFpEF, and CK-136, a cardiac troponin activator for the potential treatment HFrEF and other types of heart failure, such as right ventricular failure resulting from impaired cardiac contractility. For additional information about Cytokinetics, visit www.cytokinetics.com and follow us on X, LinkedIn, Facebook and YouTube. Forward-Looking Statements This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”). Cytokinetics disclaims any intent or obligation to update these forward-looking statements and claims the protection of the Act’s Safe Harbor for forward-looking statements. Examples of such statements include, but are not limited to, statements relating to any of our other clinical trials, statements relating to the potential benefits of omecamtiv mecarbil, aficamten, or any of our other drug candidates. Cytokinetics’ research and development activities; the design, timing, results, significance and utility of preclinical and clinical results; and the properties and potential benefits of Cytokinetics’ other drug candidates. Such statements are based on management’s current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to, potential difficulties or delays in the development, testing, regulatory approvals for trial commencement, progression or product sale or manufacturing, or production of Cytokinetics’ drug candidates that could slow or prevent clinical development or product approval; Cytokinetics’ drug candidates may have adverse side effects or inadequate therapeutic efficacy; the FDA or foreign regulatory agencies may delay or limit Cytokinetics’ ability to conduct clinical trials; Cytokinetics may be unable to obtain or maintain patent or trade secret protection for its intellectual property; standards of care may change, rendering Cytokinetics’ drug candidates obsolete; and competitive products or alternative therapies may be developed by others for the treatment of indications Cytokinetics’ drug candidates and potential drug candidates may target. For further information regarding these and other risks related to Cytokinetics’ business, investors should consult Cytokinetics’ filings with the Securities and Exchange Commission. CYTOKINETICS® and the CYTOKINETICS and C-shaped logo are registered trademarks of Cytokinetics in the U.S. and certain other countries. Contact:Cytokinetics Diane WeiserSenior Vice President, Corporate Affairs(415) 290-7757
