Genetesis’ CardioFlux MCG Receives Breakthrough Device Designation for Diagnosis of MyocardiaI Ischemia

April 13, 2023—Genetesis, Inc., an Ohio-based developer of biomagnetic cardiac imaging solutions, announced that the FDA has granted Breakthrough Device designation for the company’s flagship imaging solution, the CardioFlux magnetocardiography (MCG) system, to identify myocardial ischemia in patients who may have coronary microvascular disease (CMD).

The company stated that CMD has been hard to identify in clinical practice because of a lack of effective functional diagnostics with adequate sensitivity and an outdated perception that CMD is largely benign and nonfatal.

According to Genetesis, the FDA’s decision was based, in part, on the submission of preliminary findings from the MICRO trial, which attempted to demonstrate the use of noninvasive MCG to diagnose myocardial ischemia in patients suspected to have CMD. The company noted that the trial was supported largely by The Christ Hospital in Cincinnati, Ohio. The hospital’s participation in MICRO helped to identify a majority of the patients that participated in the study.

Odayme Quesada, MD, Medical Director of the Women’s Heart Center at The Christ Hospital Health Network, is Principal Investigator of the MICRO trial.

“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,” commented Dr. Quesada in the company’s press release. “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.”

Early data from MICRO has been submitted as an abstract to the European Society of Cardiology meeting, advised the company.