Genetesis has enrolled the first patient marking the start of its magnetocardiography as a non-invasive diagnostic strategy for suspected myocardial ischemia with the absence of obstructive coronary artery disease (MICRO2) trial at Ascension St John Hospital in Michigan, US.
The trial aims to validate the use of magnetocardiography for detecting myocardial ischemia due to underlying coronary artery obstruction.
Related: AAEON team up with Insign Medical for AI-assisted endoscopic technology
The MICRO2 study is a multicentre, prospective, observational trial. It is designed to assess the diagnostic capabilities of magnetocardiography against the reference standard of coronary flow reserve (CFR) measurements.
It will involve at least 135 patients across a minimum of six sites, notably Cleveland Clinic, Ascension St John Hospital, Hackensack Meridian Mountainside Medical Center, The Christ Hospital, Saint Luke’s Health System Kansas City, and the University of Florida.
Genetesis’ CardioFlux MCG technology is at the forefront of this study.
The trial’s successful validation could enhance the accessibility and efficiency of myocardial ischemia diagnosis.
The Genetesis-funded study is set to conclude enrolment by the end of this year.
The company plans to report the findings of the study in the first quarter of 2025.
Should the MICRO2 trial yield positive results, Genetesis plans to submit a De Novo request for market authorisation to the US Food and Drug Administration (FDA).
Genetesis product development vice-president Rhea Malhotra said: “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.
“Offering these patients a 90-second diagnostic option for 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.”
Last year, Genetesis obtained breakthrough device designation from the FDA for its imaging solution, CardioFlux magnetocardiography (MCG).
