Genetesis
Genetesis, founded in 2013, develops CardioFlux, a non-invasive diagnostic tool for myocardial ischemia, which has received FDA 510(k) clearance and Breakthrough Device Designation.
Founders
Genetesis was founded in 2013. The company's leadership has guided its innovation and growth in the field of non-invasive cardiac imaging. Through strategic partnerships and a research-oriented approach, the founders have positioned Genetesis as a key player in advancing cardiac care diagnostics.
Products
Genetesis' primary product is CardioFlux, which is the world's first clinically ready magnetocardiography (MCG) machine. CardioFlux offers a non-invasive, radiation-free, and stress-free diagnostic tool for myocardial ischemia. CardioFlux scans take just 90 seconds, with results available in 5 minutes. The device requires minimal infrastructure, only needing a standard electrical outlet. CardioFlux has received FDA 510(k) clearance and two FDA Breakthrough Device Designations.
Services
Genetesis provides advanced diagnostic services leveraging their CardioFlux MCG technology. Their services are tailored to intermediate-risk patients presenting with acute chest pain, offering a rapid, non-invasive alternative to traditional diagnostic methods. This includes the Magneto trial which enrolled 390 patients to assess the efficacy of the CardioFlux system.
History
Genetesis was founded in 2013 with a mission to revolutionize the standard of cardiac care. In 2019, their flagship product, CardioFlux, received FDA 510(k) clearance. Over the years, the company has received multiple recognitions, including the 2022 Forbes 30 Under 30 in Healthcare and the Nvidia Inception Award. Their research and innovative efforts led to the enrollment of 390 patients in the MAGNETO trial between January 2021 and October 2022. In 2023, they earned their second FDA Breakthrough Device Designation.
Sector
Genetesis operates within the healthcare and medical device sector, specifically focusing on non-invasive cardiac imaging. Their technology, magnetocardiography (MCG), is used to measure the natural magnetic fields produced by the heart, providing a rapid diagnostic tool for myocardial ischemia and coronary microvascular dysfunction. By integrating MCG into hospital workflows, they aim to improve the standard of care for patients with acute chest pain.