Myocardial Solutions Receives FDA 510(k) Clearance for MyoStrain

MORRISVILLE, N.C., February 19, 2019 – Myocardial Solutions, Inc. (MSI) announced FDA 510(k) clearance for MSI’s MyoStrain® diagnostic software, providing a new, rapid, accurate, and safe segmental strain test for quantifying subclinical cardiac dysfunction. MyoStrain quantifies cardiac contraction across 48 segments of the heart in a 6 heart beat MRI scan. MyoStrain is the first cardiac health assessment test that directly measures segmental intra-myocardial dysfunction.

John Funkhouser, CEO of MSI said, “Myocardial Solutions is leveraging the power of imaging with a novel, rapid cardiac diagnostic. MyoStrain is a prevention-focused tool to sub-clinically (before patients have symptoms) quantify cardiac dysfunction from the effects of disease, drugs or ischemia. The test’s report assists physicians to initiate early treatment.” Historically, patients are often unaware they have heart issues because the stronger areas of the heart compensate for the weaker areas. Patient cardiac symptoms usually occur after the heart is damaged.

Professor Sebastian Kelle, Senior Cardiologist at the German Heart Center Berlin, stated: “This new sensitive cardiac function test potentially opens numerous unmet markets because the test could be used not only to quantify early cardiac dysfunction but also in aiding physicians to manage drug therapies. Over time, recurring testing enables physicians to understand the effects of therapies to individualize care.”

MyoStrain testing is non-invasive, rapid, accurate, safe, patient-centric and performed without contrast injection in a 10-minute exam. Funkhouser continued, “The technology is revolutionary and provides powerful insight for physicians to manage heart health across the continuum of patient care.” Today, MyoStrain is available only on Philips MRI machines.