Coronary microvascular dysfunction

Demonstrated a Reduction of Symptoms with Short Procedural and Recovery TimesLeading Coronary Physiology Experts Appointed Co-Principal Investigators for Planned U.S. Early Feasibility Study SANTA CLARA, Calif., Oct. 28, 2024 /PRNewswire/ -- VahatiCor, a leader in cardiovascular innovation, is proud to announce the successful completion of its compassionate use study treating patients with the A-FLUX Reducer System™ for either obstructive coronary artery disease with persistent symptoms or symptomatic coronary microvascular dysfunction (CMD). The study, in which ten patients were implanted with A-FLUX (four with CMD and six with obstructive epicardial disease), marks a significant milestone in demonstrating the safety and early efficacy of a promising therapeutic option for patients suffering from these challenging and debilitating conditions. Continue Reading Based on the positive results from the compassionate use study, the Company plans to commence SERRA-I, its U.S. early feasibility study (EFS) exclusively focused on CMD patients. Coronary physiology experts Samit Shah, MD, PhD, FACC, FSCAI, an interventional cardiologist from the Yale School of Medicine, and Tim Van de Hoef, MD, PhD, FESC, an interventional cardiologist from University Medical Center Utrecht, the Netherlands will lead the trial as co-principal investigators. The A-FLUX Reducer System offers a novel, minimally invasive approach to directly improve flow within the coronary microvasculature and relieve anginal symptoms in patients with CMD. The A-FLUX Reducer System has innovative properties, including its atraumatic expansion and repositionable design. Post this "Our compassionate use study demonstrated the safety of the implant and a sustained therapeutic potential for the A-FLUX Reducer System with significant reductions in anginal symptoms," said Marwan Berrada-Sounni, Founder and Chairman, VahatiCor. "We are excited to address the unmet clinical needs of CMD patients and delighted to take the next step in initiating the SERRA-I EFS, upon FDA IDE approval, with Dr. Shah and Dr. Van de Hoef so that we can bring this important therapy to patients." Patients treated with the A-FLUX Reducer System reported rapid symptom improvements and returned to their daily activities with minimal recovery time. The short nine-minute average implantation procedure time and clinical outcomes highlighted the implant's potential to become a frontline device therapy for patients with persistently symptomatic CMD. "Patients with CMD, which is more common in women, experience significant symptoms that can happen at rest and during exertion," noted Dr. Shah. "There is a real need for an effective treatment for these patients. The A-FLUX Reducer System has innovative properties, including its atraumatic expansion and repositionable design. I look forward to supporting the development of clinical evidence for this novel therapy." The A-FLUX Reducer System is engineered with SwiftCell Technology™, a small-cell proprietary design based on computational modeling, to redistribute oxygen supply to the sub-endocardium layer of the heart muscle. As Dr. Van de Hoef explained, "About half of the patients undergoing an invasive angiography are found not to have obstructive coronary artery disease but, in fact, have coronary microvascular disease. Increasingly, more patients are likely to be identified as centers begin adopting the strong guidelines recently published by the European Society of Cardiology. These patients have no dedicated treatment available. Coronary sinus reduction and the advanced features of the A-FLUX device carry significant potential to help these patients return to normal daily activities." CMD occurs when the small coronary arteries within the heart muscle (coronary microvasculature) fail to dilate properly upon exertion, reducing blood flow to the heart muscle and creating discomforting angina symptoms. Millions of CMD patients worldwide suffer from persistent chest pressure, tightness, and chest pain, with no current viable options for symptom relief. Left untreated, diagnosis of CMD results in a fourfold elevated mortality risk compared to the general population.[1] About VahatiCor VahatiCor, Inc., a T45 Labs portfolio company, is committed to revolutionizing the treatment of coronary microvascular dysfunction through cutting-edge technologies and minimally invasive therapies to provide rapid relief and empower patients to reclaim their daily lives. To learn more, please visit : Investigational Device. Limited by Federal (or US) law to investigational use only. Not available for sale. [1] Gdowski MA, Murthy VL, Doering M, Monroy-Gonzalez AG, Slart R, Brown DL. Association of Isolated Coronary Microvascular Dysfunction With Mortality and Major Adverse Cardiac Events: A Systematic Review and Meta-Analysis of Aggregate Data. J Am Heart Assoc. 2020 May 5;9(9):e014954. doi: 10.1161/JAHA.119.014954. Epub 2020 Apr 29. PMID: 32345133; PMCID: PMC7428565. SOURCE VahatiCor, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Newly announced Canadian license marks the first approval of any kind of MCG device in Health Canada history MASON, Ohio, Sept. 20, 2024 /PRNewswire/ -- Genetesis, Inc., a leader in the field of magnetocardiography (MCG), today announced that Health Canada has approved the CardioFlux Magnetocardiograph with a license for use by physicians to aid in the diagnosis of myocardial ischemia. "Our team is thrilled by the achievement of this milestone, and it certainly represents the culmination of several years of work conducted in partnership with some incredible investigators and study teams," said Genetesis CEO and Co-Founder Peeyush Shrivastava. "This is our first foray beyond the US, and we're excited to partner with physicians in Canada to improve both patient outcomes AND patient experience." Approval was based on the submission of evidence from multiple clinical trials conducted by Genetesis, including both the MAGNETO (suspected ACS in the ER) and MICRO (suspected CMD in patients with angina but confirmed non-obstructed arteries) studies. Submitted data provided compelling evidence of CardioFlux MCG's ability to enhance diagnostic accuracy without the need for contrast agents, radiation, or pharmaceutical-induced stress. The MAGNETO trial examined CardioFlux MCG's ability to identify myocardial ischemia in patients presenting with chest pain in the Emergency Department (with the notable advantage of being able to provide disposition within a patient's first four hours of presenting). MICRO was the first known study in MCG history to examine MCG's efficacy in detecting myocardial ischemia in patients with angina who have confirmed non-obstructed arteries, a condition formally known as ANOCA. CardioFlux MCG is a zero-contact imaging modality that assesses cardiac function by examining the tiny magnetic fields produced by the heart's regular electrical activity to identify electrophysiological signs of myocardial ischemia. Notably, CardioFlux MCG requires just 90 seconds of data acquisition and does not require any stress, injections, or radiation. While approved by Health Canada, CardioFlux MCG is not yet accessible to a vast majority of Canadians. Genetesis is working diligently to identify Canadian partners interested in early adoption and integration of MCG technologies into the current standard of care. About Genetesis To support the ischemia-first paradigm that is needed to address the entire spectrum of ischemic heart disease, Genetesis, Inc. has translated over 60 years of magnetocardiography research into CardioFlux MCG, a 90-second cardiac imaging modality administered to patients without the need for ionizing radiation, pharmaceuticals, or induced stress. CardioFlux MCG has already been 510(k) cleared by the FDA and is currently being studied for its potential to provide patients and physicians with a near-instant functional assessment of myocardial ischemia, including the ability to independently assess microvascular function. Based in Mason, Ohio, Genetesis has been working to redefine the way ischemic heart disease is detected and understood since 2013. For more information, visit . About MAGNETO MAGNETO (Accelerated Magnetocardiography in the Evaluation of Patients with Suspected Cardiac Ischemia) was a multicenter, prospective, observational cohort study which enrolled 390 low-to-intermediate risk chest pain patients with suspected acute coronary syndrome (ACS) in the emergency department (ED). The study compared the diagnostic performance of MCG with "standard of care" noninvasive stress testing for the detection of myocardial ischemia. MAGNETO was conducted with the support of four enrolling sites – The Cleveland Clinic, Wake Forest University School of Medicine, Ascension St. John Hospital, Corewell Health William Beaumont University Hospital – and was funded by Genetesis, Inc. About MICRO MICRO (MCG as a Noninvasive Diagnostic Strategy for Suspected Coronary Microvascular Dysfunction) was a multicenter, prospective, observational study which enrolled 79 patients with angina despite presenting with no obstructive coronary artery disease (ANOCA). The study compared the diagnostic performance of MCG to a reference standard of invasively measured Coronary Flow Reserve (CFR) for the detection of myocardial ischemia caused by underlying coronary microvascular dysfunction, defined by a CFR of less than 2.0. MICRO was conducted with the support of three enrolling sites – Ascension St. John Hospital, The Christ Hospital, and The Cleveland Clinic – and was funded by Genetesis, Inc. SOURCE Genetesis WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

MICRO2 aims to build upon early evidence demonstrating MCG's ability to aid in the noninvasive diagnosis of Coronary Microvascular Dysfunction MASON, Ohio, July 3, 2024 /PRNewswire/ -- Genetesis, Inc., a leader in the field of magnetocardiography (MCG), today announced the formal launch of the MICRO2 trial, marked by the enrollment of the trial's first patient at Ascension St. John Hospital in Detroit, Michigan, under Drs. Edouard Daher, MD, and Nishtha Sareen, MD, MPH, FACC, FSCAI, both of whom are interventional cardiologists. Designed to validate evidence generated previously during the MICRO and MICRO-T trials, MICRO2 will evaluate magnetocardiography's (MCG) ability to noninvasively detect myocardial ischemia caused by underlying coronary microvascular dysfunction (CMD). Data produced during MICRO2 will be delivered to the FDA inside a De Novo request for market authorization of CardioFlux MCG. Should this De Novo request be granted, it would represent the first time a diagnostic device has been approved by the FDA for this application. Evidence clearly supports the recognition of CMD as a distinct clinical entity, but diagnosing CMD effectively poses a major challenge for the current standard of care, as traditional risk factors for cardiovascular disease, like atherosclerosis, have not proven to correlate with the presence of CMD. For patients seeking a diagnosis, the first step in their journey typically involves being classified as suffering from ischemia with no evidence of obstructed arteries (INOCA). "Many of the patients we speak to who suffer from CMD often describe a diagnostic journey that begins with being told their symptoms are non-cardiac due to a negative result on CCTA or invasive angiography. Unfortunately, these patients are being told something that is later proven to be untrue," said Rhea Malhotra, Vice President of Product Development at Genetesis. "Offering these patients a 90-second diagnostic option for diagnosing ischemia that could be used at the beginning of this diagnostic journey would be a huge step forward in fixing this unmet clinical need today." INOCA is currently estimated to impact at least 4 million people in the United States today, with over 50% of these patients believed to suffer from some form of CMD. Worse still, there is overwhelming evidence demonstrating that these patients will see more physicians and have more hospitalizations than otherwise healthy people while suffering from measurably worse outcomes, both in terms of quality of life and long-term health. For reasons that are not entirely understood quite yet, the vast majority of these patients today are women. The application of CardioFlux MCG for diagnosing these patients would represent a significant opportunity to reduce the cost and burden typically associated with a diagnosis without compromising on diagnostic accuracy, and if validated by MICRO2, could make the possibility of a diagnosis far more accessible than it currently is today. Genetesis expects to analyze and report results from the MICRO2 trial in Q1 of 2025, followed by a De Novo submission to FDA shortly thereafter. About Genetesis To support the ischemia-first paradigm that is needed to address the entire spectrum of ischemic heart disease, Genetesis, Inc. has translated over 60 years of magnetocardiography research into CardioFlux MCG, a 90-second cardiac imaging modality administered to patients without the need for ionizing radiation, pharmaceuticals, or induced stress. CardioFlux MCG has already been 510(k) cleared by the FDA and is currently being studied for its potential to provide patients and physicians with a near-instant functional assessment of myocardial ischemia, including the ability to independently assess microvascular function. Based in Mason, Ohio, Genetesis has been working to redefine the way ischemic heart disease is detected and understood since 2013. For more information, visit . About MICRO2 MICRO2 (Magnetocardiography as a Noninvasive Diagnostic Strategy for Suspected Myocardial Ischemia with the Absence of Obstructive Coronary Artery Disease) is a multicenter, prospective, observational study powered to validate magnetocardiography's ability to detect myocardial ischemia caused by underlying coronary microvascular dysfunction. The study will compare the diagnostic performance of MCG to a reference standard of invasively measured Coronary Flow Reserve (CFR). MICRO2 is expected to enroll at least 135 patients and will be conducted with the support of at least six enrolling sites – Ascension St. John Hospital, Cleveland Clinic, Hackensack Meridian Mountainside Medical Center, Saint Luke's Health System Kansas City, The Christ Hospital, and University of Florida – and is funded by Genetesis, Inc. SOURCE Genetesis