Results provide early proof-of-concept data of MCG’s unique potential as a 90-second, zero-contact diagnostic option for patients suspected of suffering from ischemia despite having no obstructed arteries
MASON, Ohio – July 15, 2024 – Genetesis, Inc., a leader in the field of magnetocardiography (MCG), today announced that official results from its MICRO trial have officially been published in a special issue of the American Heart Journal Plus: Cardiology Research and Practice, titled “Magnetocardiography Rediscovered: New Perspectives on a ‘Novel’ Modality”.
These initial results from MICRO demonstrate early evidence of MCG’s potential ability to identify myocardial ischemia in patients who have underlying coronary microvascular dysfunction (CMD) and represent the first time MCG has been formally explored in this patient population. Today, CMD is most commonly diagnosed through functional invasive angiography, a procedure which exposes patients to ionizing radiation and represents a clear limitation of accessibility for the majority of affected patients.
“This pilot data demonstrated MCG’s ability to detect CMD in patients with ANOCA [angina with non-obstructive coronary arteries] using a 90-second non-invasive scan without the need for an intravenous stressor or ionizing radiation,” said Dr. Odayme Quesada, MD, FACC, Medical Director of the Women’s Heart Center at The Christ Hospital Health Network and Principal Investigator on MICRO. “Studies are underway to validate the findings of our pilot before MCG should be considered for broad-based use. If this early data is accurate, MCG holds tremendous potential for the diagnosis of CMD in patients with ANOCA.”
Key takeaways from MICRO include:
Annually, at least 4 million people in the United States alone are estimated to experience angina and anginal equivalents related to myocardial ischemia despite having no significant obstruction in their coronary arteries (a condition known as INOCA), and CMD is widely thought to be one of the most common underlying causes of this condition. However, CMD is underdiagnosed due to the limitations of current diagnostic tools (invasive, radiation exposure, cost) and an outdated perception among some clinicians that CMD is largely benign. Research consistently demonstrates that these patients – who, for a multitude of reasons, are predominantly women – suffer from substantially higher rates of hospitalization (i.e. resource utilization) and death.
“Our explorations thus far into CMD are a symbol of our commitment to demonstrating MCG’s utility across the entire spectrum of ischemic heart disease. It’s also clear that with the increasing use of CCTA as an anatomical test for disease, the need for a fast functional assessment of ischemia is perhaps even more important than before,” said Dr. Robert Takla, MD, FACEP, former Chief and Medical Director of Emergency Medicine at Ascension St. John Hospital and current Chief Medical Officer at Genetesis. “I also think it’s important to take a moment to extend a heartfelt ‘thank you’ and ‘congratulations’ to our physician partners and their respective research teams for their contributions throughout this study.”
Based on these positive results from MICRO, Genetesis intends to move forward with a statistically powered, FDA-facing study – aptly dubbed MICRO2 – with the intention of submitting data from this follow-on study to the FDA as part of a De Novo submission for potential full market authorization. Genetesis expects to formally submit this data to the FDA early next year.
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 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.
Contact
Ryan Yoo
Chief of Staff
ryan.yoo@genetesis.com
(949) 742-0562