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