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 https://www.genetesis.com .
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.
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SOURCE Genetesis