Angina, Stable

First-of-its-kind Dual-Drug Therapy for Coronary De Novo Disease Moves Toward U.S. Clinical Phase Novel Nanoparticle Technology Platform Aims to Deliver Two Proven Drugs for Vessel Patency and Restenosis Prevention SANTA CLARA, Calif., Oct. 26, 2024 /PRNewswire/ -- Advanced NanoTherapies (ANT), a clinical-stage medical device company committed to solving the most significant challenges in vascular disease through innovative applications of nanotechnology, announced positive results from its first-in-human (FIH) trial evaluating the next-generation SirPlux™ Duo Drug-Coated Balloon (DCB). The Company also announced plans to proceed towards executing its U.S. early feasibility study (EFS), known as DYNAMIC DUO I, to evaluate the safety and performance of the SirPlux™ Duo DCB in de novo coronary lesions. SirPlux™ Duo DCB delivers a synergistic dual-drug therapy of sirolimus and paclitaxel and is engineered for vessel patency and restenosis prevention. Continue Reading SirPlux™ Duo Drug-Coated Balloon (DCB) "The innovative drug delivery platform of the SirPlux Duo DCB is poised to redefine how coronary disease is treated," stated Dr. Bernardo Cortese, MD, FESC, FSCAI, Director, Interventional Coronary Center, University Hospitals and Professor of Medicine, Case Western Reserve. "By combining two proven drugs with the novel nanoparticle technology, SirPlux Duo DCB aims to minimize drug flaking, deliver sustained drug therapy at therapeutic levels, and get the best characteristics of the two drugs, theoretically making it a strong front-line device alternative to current DCBs or drug-eluting stents." SirPlux Duo DCB is the only therapy designed to deliver sirolimus and paclitaxel simultaneously to inhibit cell growth at a higher potency and efficient dose. ANT's novel nanoparticle drug encapsulation and delivery platform is designed to provide the two drugs with safe, reliable, and sustained long-term in-tissue bioavailability with no stent burden. "We are thrilled to take this next step in further validating the clinical performance of SirPlux™ Duo DCB, a novel technology licensed from the Cleveland Clinic," said Marwan Berrada-Sounni, Co-founder and CEO of ANT. "Moving forward with our DYNAMIC DUO I EFS aligns with our vision of advancing nanotechnology-driven solutions that combine the power of sirolimus and paclitaxel to offer a safe and prolonged therapy without leaving a permanent implant behind." The planned DYNAMIC DUO I EFS study is a prospective, multi-center, non-randomized study that will enroll and treat symptomatic stable angina, unstable angina, or NSTEMI patients with de novo coronary lesions with reference vessel diameters of 2 to 4 mm. The results from this study will inform the Company on how to advance its clinical programs to broader commercialization plans in the U.S. and global markets. About Advanced NanoTherapies (ANT) Advanced NanoTherapies, Inc., a member of the T45 Labs portfolio, is a highly specialized medical device company developing a nanoparticle technology-based platform for drug delivery. The Company focuses on minimally invasive cardiovascular applications to bring a safer therapeutic option to patients with arterial disease. The company's first product is the SirPlux Duo Drug-Coated Balloon (DCB), a next-generation front-line therapy for minimally invasive catheter interventions. To learn more about Advanced NanoTherapies, visit : Products are currently in development and are not available for sale. SOURCE Advanced NanoTherapies WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Long-term outcomes data from ADVANCE-DK Registry with HeartFlow FFRCT and Plaque Analysis and ongoing clinical studies highlighting CCTA and FFRCT diagnostic pathway to be discussed in six presentations New data build upon the growing body of clinical evidence supporting non-invasive FFRCT technology and plaque analysis in the diagnosis and management of coronary artery disease MOUNTAIN VIEW, Calif., Oct. 14, 2024 (GLOBE NEWSWIRE) -- HeartFlow, the global leader in non-invasive artificial intelligence (AI) heart care solutions, today announced it will present seven-year data from the ADVANCE-DK study, a subset from the larger ADVANCE Registry, which evaluated utility and clinical outcomes of HeartFlow’s AI-enabled FFRCT and Plaque Analysis in clinically stable, symptomatic patients with coronary artery disease (CAD). Data from the ADVANCE-DK study and other clinical studies will be presented at the 36th annual Transcatheter Cardiovascular Therapeutics® (TCT) conference, which will take place October 27-30, 2024 in Washington, D.C. “The ADVANCE registry helps us better understand whether more complete revascularization, as defined by FFRCT, is associated with improved long-term cardiovascular outcomes,” said Campbell Rogers, M.D., F.A.C.C., Chief Medical Officer of HeartFlow. “Three-year data from this registry confirmed that patients with both abnormal FFRCT and high plaque burden had two-and-a-half to three times greater risk of adverse cardiac events compared to patients with only abnormal FFRCT or high plaque volume. We are excited to present seven-year data and build on our body of evidence demonstrating FFRCT and AI-enabled plaque assessment as non-invasive approaches which can help physicians better quantify CAD risk in their patients.” At TCT, HeartFlow will also present: Late-breaking data evaluating the capacity of FFRCT and coronary computed tomography angiography (CCTA) to rule out significant lesions in high-risk non-ST elevation acute coronary syndromes (NSTE-ACS).Data from FUTURE-AS, an international, prospective, multicenter registry of patients with severe aortic stenosis (AS) referred for transcatheter aortic valve replacement (TAVR) being assessed for CAD with CCTA and FFRCT.New data from FASTTRACK-CABG, a single-arm, multicenter, prospective study assessing safety and feasibility of bypass surgery in patients with complex CAD solely based on CCTA combined with FFRCT.Data highlighting the value for pre-procedural planning of combining FFRCT, virtual percutaneous coronary intervention (PCI), and myocardial mass.Analysis of initial FFRCT-based virtual PCI for pre-procedural planning in the U.S. Details of each presentation are as follows: Title: Completeness of Revascularization by FFRCT and Long-term Prognosis in Stable Angina: A Seven-Year Follow-up of the ADVANCE-DK RegistryPresenter: Kristian Taekker Madsen, M.D., Ph.D.Date: Sunday, October 27, 2024Time: 7:30-8:45 AM EDTSession: TCT WorldLink Forum: Best Global Research in Coronary ImagingLocation: Presentation Theater 3, Innovation & Exhibit Hall (Halls A-C) Title: TCT 288: Comparative Analysis of FFR Derived From CCTA, Murray Law-Based Quantitative Flow Ratio and Quantitative Flow Ratio at Sequential Side Branches in Patients With Complex CAD: Insights From the FASTTRACK CABG StudyPresenter: Kotaro Miyashita, M.D.Date: Sunday, October 27, 2024Time: 9:00-9:50 AM EDTSession: Moderated Abstracts Station 2Location: Innovation & Exhibit Hall (Halls A-C) Title: TCT 172: Usefulness of FFRCT to Exclude Hemodynamically Significant Lesions in High-Risk NSTE-ACS Presenter: Georgios Tzimas, M.D.Date: Monday, October 28, 2024Time: 4:00-5:30 PM EDTSession: Moderated Abstracts Station 2Location: Innovation & Exhibit Hall (Halls A-C) Title: TCT 830: Feasibility and Utility of Anatomical and Physiological Evaluation of Coronary Disease With Cardiac CT in Severe Aortic Stenosis (FUTURE-AS Registry)Presenters: Abdul Rahman Ihdayhid, M.D., Ph.D.Moderators: Philippe PM Garot, M.D., Marie-France Poulin, M.D.Date: Tuesday, October 29, 2024Time: 8:00-9:00 AM EDTSession: TAVR and CAD - 1Location: Moderated Abstracts Station 5, Innovation & Exhibit Hall (Halls A-C) Title: TCT 221: Coronary Computed Tomography Angiography-Guided Bifurcation Percutaneous Coronary Intervention: Role of FFRCT Virtual PCI and Myocardial Mass for Pre-Procedural PlanningPresenters: Pedro Carvalho, M.D.Moderators: Hector M. Garcia-Garcia, M.D., Ph.D., John J. Lopez, M.D.Date: Tuesday, October 29, 2024Time: 2:00-3:00 PM EDTSession: Anatomy-derived Coronary Physiology – 2Location: Moderated Abstracts Station 2, Innovation & Exhibit Hall (Halls A-C) Title: TCT 96: Coronary Computed Tomography Angiography for Percutaneous Coronary Intervention: Initial US Experience With FFRCT-Based Virtual PCI for Pre-Procedural PlanningPresenters: Pedro Carvalho, M.D.Moderators: Louis A. Cannon, M.D., Christopher Irobunda. M.D.Date: Wednesday, October 30, 2024Time: 9:00-9:56 AM EDTSession: Novel Percutaneous TechniquesLocation: Moderated Abstracts Station 6, Innovation & Exhibit Hall (Halls A-C) Heartflow invites attendees to a lunch symposium, “Utilizing Coronary CTA & HeartFlow AI to Non-Invasively Assess Anatomy, Physiology and Plaque,” led by a panel of well-respected physicians including Ziad A. Ali, M.D., Suzanne J. Baron, M.D., Nick Curzen, M.D., Jimmy Lee Kerrigan, M.D. and Akiko Maehara, M.D. The symposium will take place on Tuesday, October 29, 2024, from 12:30-1:30 PM EDT in the FDA Theater, Innovation & Exhibit Hall (Halls A-C). 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. 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 ContactElliot Levymedia@heartflow.com Investor ContactNick Laudiconlaudico@heartflow.com

The drug is aimed at treating chronic stable angina pectoris and conducted in Portugal, the exploratory phase 1a pharmacokinetics study ​, involving 16 healthy adult volunteers, concluded just before the end of last year (2023). The study focused on evaluating the pharmacokinetics of AUX-001, an oral, extended-release, once-daily version of nicorandil, a medication used to treat angina. Additionally, it aimed to assess the safety and tolerability of the investigational anti-anginal drug. The topline results of the study demonstrated that AUX-001 effectively prolonged the half-life of nicorandil from the standard 49±8 minutes, as observed with the current immediate-release form administered twice daily, to over nine hours. Dawid Chabowski, science and operational manager at Auxilius Pharma, said: “A result like this bodes well for AUX-001’s potential to extend daylong coverage of its anti-ischemic effect with just one capsule a day.” The study revealed that AUX-001 was well-tolerated by participants, with headaches being the most common adverse event. Auxilius chief medical officer, Uwe Tigör, emphasized the significance of managing headaches, he said: “Ours is probably one of very few angina studies using oral nicorandil with no headache related patient dropouts, thanks to our preemptive management and proactive patient communication.” The successful outcomes of this trial mark a significant milestone for Auxilius Pharma's R&D efforts. CEO Jed Litwiniuk is confident in the trial's results. He said: “We are reassured by the outcomes of the trial.” googletag.cmd.push(function () { googletag.display('text-ad1'); }); Auxilius Pharma's strategic move to introduce AUX-001 to the US market via the 505(b)2 regulatory pathway is poised to revolutionize cardiac care. With AUX-001 anticipated to gain up to five years of market exclusivity upon approval, coupled with comprehensive intellectual property rights secured globally, it is positioned to significantly impact the treatment landscape for chronic angina in the United States and beyond. Chronic Stable Angina Pectoris (CSAP) is one of the most common cardiovascular conditions affecting over 11 million patients in the US. It is a common manifestation of atherosclerotic coronary artery disease (CAD), marked by chest pain or discomfort due to reduced myocardial blood flow, usually triggered by physical exertion, emotional stress, or other factors. CSAP prevalence is significant and growing, with around 650.000 new cases annually in the US. Standard of care for most patients with stable coronary artery disease underlying their chronic angina optimized medical therapy with anti-anginal medications. Litwiniuk has announced plans for an IND filing for AUX-001 later this year and said the company is actively seeking partnerships with mid- to large-size pharmaceutical companies to advance the clinical development of AUX-001. AUX-001 offers efficacy comparable to conventional anti-anginal medications such as beta-blockers, calcium channel blockers, and long-acting nitrates while also potentially enhancing control of the underlying coronary disease and reducing angina related hospitalizations.