Ms.Medicine and Genetesis Initiate WACE-MCG Clinical Registry
New registry of up to 200 Ms.Medicine patients at risk of cardiovascular disease will compare CardioFlux results to the conventional pathway for diagnosis
Partner News | Published: Tuesday, October 6, 2020
Mason, OH – October 5, 2020 – Ms.Medicine and Genetesis today announced the start of a clinical registry for Women’s Assessed Cardiovascular Evaluation with Magnetocardiography (WACE-MCG).
The WACE-MCG registry is designed to compare the usual approach of diagnosing and evaluating patients with an elevated risk of Cardiovascular Disease (CVD) with the results of a CardioFlux scan, a novel device that provides a biomagnetic view of cardiac function. The WACE-MCG registry will evaluate whether a CardioFlux scan can improve the outcomes, effectiveness and cost of monitoring patients at risk of CVD. CardioFlux utilizes no radiation, is completely contactless and is done in less than 5 minutes. The registry will enroll up to 200 Ms.Medicine patients at Mason’s CardioFlux Imaging Institute, a collaborative initiative between Genetesis and the City of Mason, to demonstrate that this technology will create a faster, less invasive and more patient-centric standard of care.
CVD is the number one cause of death for women over the age of 25, accounting for 1 of every 3 female deaths. Even though the death rate from cardiovascular diseases in men has decreased, it continues to increase in women1. The marriage between women’s atypical symptoms and less sensitive diagnostic testing for women has created many issues in accurately diagnosing this population with CVD2. Studies show that women with cardiac risk factors, including diabetes, hypertension, hyperlipidemia, are less likely to have those risk factors controlled and are more likely to develop serious conditions, such as Heart Failure, as a result.
“The fundamental health disparities in cardiovascular care between men and women are profound,” said Genetesis Director of Product and Study Director, Rhea Malhotra. “Both Genetesis and Ms.Medicine have missions focused on patient-centric care. The WACE-MCG registry is our attempt to ensure that we do not just acknowledge the shortcomings in cardiovascular disease monitoring in women, but also make actionable efforts to be a part of the solution.”
In the WACE-MCG registry, Ms.Medicine patients who have cardiac risk factors (including, but not limited to, diabetes, hypertension, hyperlipemia, family history of Coronary Artery Disease, smoking), recovered from COVID-19, recovered from and/or still undergoing treatment for breast cancer and women that have already been referred to a cardiologist, will be asked to participate. Patients enrolled in the registry will be asked to receive a CardioFlux scan at the CardioFlux Imaging Institute, but will proceed with their standard of care.
“Advancing women’s health is the mission of Ms.Medicine,” said Founder and CEO of Ms.Medicine and WACE-MCG PI, Dr. Lisa Larkin. “Unfortunately there continues to be a gap in our understanding of cardiovascular disease in women compared to men, frequently causing delays in diagnosis, missed diagnoses, among other major clinical shortfalls. Ms.Medicine’s collaboration with Genetesis is an opportunity for us to participate in advancing gender specific science in cardiovascular disease.”
To date, CardioFlux has scanned more than 400 patients presenting to the Emergency Department or outpatient clinics with chest pain.
Genetesis® is a rapidly growing medical technology company redefining the way patients with a risk of myocardial ischemia and coronary artery disease are clinically diagnosed, monitored and screened. Genetesis has built an end-to-end imaging solution, by combining CardioFlux®, a first-in-class FDA-cleared noninvasive biomagnetic imaging technology with Faraday, the company’s proprietary cloud-based image analysis and workflow solution.
About Mason’s CardioFlux Imaging Institute
Genetesis and the City of Mason, Ohio, worked collaboratively to advance Mason’s CardioFlux Imaging Institute to help Genetesis bring this revolutionary cardiovascular imaging technology to physician-referred community members. The City of Mason, a hub for biohealth technology and innovation, located Genetesis in the third campus of the Mason Tech Elevator. This unique platform fosters an environment where young growth companies with scalable technology, particularly those focused on solving cardiovascular and mental health diagnosis and treatment challenges, have access to resources and talent to bring new concepts to market.
- “Women & Cardiovascular Disease.” Cleveland Clinic, 2019, my.clevelandclinic.org/health/diseases/17645-women--cardiovascular-disease.
- Duda-Pyszny, Dominika, et al. “Coronary Artery Disease in Women.” Kardiochirurgia i Torakochirurgia Polska = Polish Journal of Cardio-Thoracic Surgery, Termedia Publishing House, Mar. 2018, www.ncbi.nlm.nih.gov/pmc/articles/PMC5907616/.