Genetesis Gets Breakthrough Nod for CardioFlux MCG

Genetesis, a biomagnetic cardiac imaging solutions company, has been granted U.S. Food and Drug Administration (FDA) Breakthrough Device designation for its flagship CardioFlux MCG to spot myocardial ischemia in patients who may be suffering from coronary microvascular disease (CMD).
 
CMD has historically been difficult to identify because of a lack of effective functional diagnostics with adequate sensitivity, as well as a perception that CMD is largely benign and not fatal.
 
The FDA’s decision rested, in part, on submission of preliminary findings from the MICRO trial, which aimed to show use of non-invasive magnetocardiography (MCG) to diagnose myocardial ischemia in patients suspected to be suffering from CMD. This effort was supported in large part by The Christ Hospital, whose participation in MICRO helped to identify a majority of the patients that participated in the study.
 
“Many of the patients I see who I find to have CMD come to me with a history of past stress tests that either failed to show abnormalities or were largely inconclusive,” Dr. Odayme Quesada, MD, medical director of the Women’s Heart Center at The Christ Hospital Health Network and principal investigator on the MICRO study, told the press. “If MCG works as intended and can lead to far earlier management of CMD, it’s exactly these patients who stand to benefit the most.”
 
“It’s our mission at The Christ Hospital Health Network to do everything it takes to identify and support underserved populations,” added Dr. Timothy Henry, M.D., interventional cardiologist and medical director of The Christ Hospital Lindner Center for Research and Education. “Through various activities and investments, like our Women’s Heart Center, we’re making very real progress on that goal. Our partnership with Genetesis on MICRO and their innovations in cardiac imaging aligns perfectly with that mission.”
 
“This milestone is a great step forward for patients who suffer from the impacts of CMD, many of whom do so unknowingly, and illustrates the FDA’s awareness that effective CMD diagnostics are largely inaccessible to most patients,” said Dr. Robert Takla, M.D., chief medical officer at Genetesis. “But more broadly, I think the FDA’s willingness to grant us two back-to-back Breakthrough designations for myocardial ischemia in two different patient populations – this time for patients who may be suffering from CMD—illustrates the need for a new paradigm in cardiac imaging that focuses on identifying ischemia and interrogating cardiac function, as opposed to solely anatomy, within all care settings.”