Genetesis Commences MICRO2 Trial with First Patient Enrollment

Thursday, July 04, 2024

Genetesis, has officially launched the MICRO2 trial with the enrollment of its first patient at Ascension St. John Hospital in Detroit, Michigan, led by Drs. Edouard Daher and Nishtha Sareen.

This trial is a multicenter, prospective study designed to validate the effectiveness of magnetocardiography (MCG) in detecting myocardial ischemia caused by coronary microvascular dysfunction.

The study will compare MCG's diagnostic performance against invasively measured Coronary Flow Reserve (CFR).

Coronary microvascular dysfunction (CMD) is recognized as a distinct clinical condition but is challenging to diagnose using current methods.

Many patients with CMD are initially misdiagnosed with ischemia despite having no obstructed coronary arteries (INOCA), leading to significant health impacts, especially among women.

The MICRO2 trial aims to enroll at least 135 patients across several sites, including Cleveland Clinic, Hackensack Meridian Mountainside Medical Center, and others, supported by funding from Genetesis, Inc.

If successful, the trial's results, expected in early 2025, may lead to FDA approval for MCG as a groundbreaking diagnostic tool for CMD-associated ischemia, potentially improving early detection and treatment outcomes in affected patients.






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