FDA’s Breakthrough Designation is Here: What This Means for MCG & Why It Matters

Published on
April 19, 2023
Dr. Robert Takla, MD
Chief Medical Officer

FDA’s recent Breakthrough Device designation for CardioFlux MCG as a potential diagnostic modality for patients who may have ischemia but show little to no evidence of coronary artery disease is a landmark that elevates the role magnetocardiography stands to play in clinical practice for two key reasons:

It assigns importance to Coronary Microvascular Disease (CMD) as a public health challenge and recognizes non-obstructive ischemia as a condition that requires a significant clinical and technological shift away from the default of a purely anatomical testing approach.

It recognizes CardioFlux MCG as a non-invasive test that has the capacity and potential to deliver the change needed so that physicians can better address an unmet clinical need in patients suspected of having CMD.

For far too many years now, patients, especially women, suffering from what is often called “atypical” chest pain have been left without a diagnosis or corresponding treatment plan due to an absence of notable plaque in any of their major coronary arteries.

This made sense given that the prevailing view on cardiovascular disease - centered on the detection and treatment of Coronary Artery Disease (CAD) - focused primarily on the detection of atherosclerosis and anatomically-defined disease. Unfortunately, the unintended negative impact of this focus on coronary anatomy was that symptomatic patients who didn’t have blockages inside the vessels of their heart were quite frequently told their symptoms were either “atypical” or, perhaps even worse, non-cardiac in nature.

However, the past decade of science and research has evolved our understanding of cardiovascular disease to more broadly reflect the full spectrum of how heart disease may present clinically, reflected in an increased need to interrogate patient ischemia under the umbrella of Ischemic Heart Disease (IHD).

Despite this evolution in the literature, clinical implementation of this new understanding continues to lag behind due to several factors. The most important factor preventing clinical adoption of this new paradigm is the simple fact that early forms of functionally significant ischemia are often “invisible” to most, if not all, of the diagnostic modalities that currently make up our standard of care, including broadly available tests like exercise stress testing and nuclear imaging (and even newer technologies like coronary CTA).

Most importantly though, the present evidence is quite clear on a single fact when it comes to the disease burden that patients are experiencing today: CMD is simply not benign.

More specifically, CMD is associated with a nearly 4-fold increase in mortality and 5-fold increase in major adverse cardiac events (MACE), which includes both cardiac death and heart attacks.

This is where the FDA’s Breakthrough Devices program comes into play. Created in 2015, the Breakthrough Device program was intended to identify innovative medical devices that address unmet clinical needs and provide device manufacturers with a way to expedite their review and subsequent approval by the FDA.

In order to qualify, Genetesis first had to show that CardioFlux provides for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions. Second, we had to demonstrate that one or more of the following was true:

CardioFlux represents Breakthrough technology

✓ No approved or cleared alternatives currently exist

✓ CardioFlux offers significant advantages over existing approved or cleared alternatives

✓ CardioFlux availability is in the best interest of patients

To be clear, this designation is not the same thing as a full market authorization, but it provides Genetesis a clear and expedited pathway to receive that final approval from the FDA in the future.

A consensus is starting to form around CMD, one which recognizes the existence of a large patient population currently experiencing a form of heart disease which has been shown to:

✓ Irreversibly impact patient prognosis,

✓ Significantly decrease patient quality of life, and

✓ Frequently evade detection under the current standard of care.

In a sign of progress, this latest announcement from the FDA means that they agree with these same conclusions. For patients who currently or will in the future suffer from the impacts of CMD, news of upcoming diagnostics and therapeutics can’t come fast enough. Just ask any patient who eventually received a diagnosis of CMD after being turned away and told their condition was non-cardiac in nature.

They’re a lot more common than any of us may readily want to admit.

To read Genetesis' official announcement on receiving Breakthrough Device designation, go here.