A Greater Cincinnati medtech startup backed by Mark Cuban and others has landed its second key clearance from the U.S. Food and Drug Administration — its next step in pursuing full market authorization as part of its goal to better treat millions of cardiac patients.
Mason-based Genetesis, one of the region’s best-funded startups, announced Thursday the U.S. Food and Drug Administration granted “breakthrough device” designation for its flagship solution, CardioFlux, to identify myocardial ischemia in patients who may be suffering from coronary microvascular disease, or CMD. Myocardial ischemia occurs when the amount of oxygen that reaches the heart muscle is decreased, most commonly the result of coronary artery disease.
Historically, CMD has been hard to identify, and there’s an outdated perception that CMD is largely benign and non-fatal, Genetesis said. Currently, the only diagnostic options involve either an invasive procedure or radiation exposure.
The company plans to pursue full market authorization so physicians can diagnose these patients with CardioFlux instead, which offers “none of the drawbacks alternative diagnostics today have,” Ryan Yoo, the company’s director of product marketing, told me.
CardioFlux, which uses non-invasive magnetocardiography, a technique used to measure the magnetic fields produced by electrical activity in the heart, can rapidly scan for various heart conditions without the use of any radiation, contrast or exercise.
In terms of commercialization, Yoo said the latest designation basically guarantees the company a “fastpass” with the FDA when it pursues full market authorization for diagnosing this patient population.
This is its second FDA breakthrough designation.
“This milestone is a great step forward for patients who suffer from the impacts of CMD, many of whom do so unknowingly, and illustrates the FDA’s awareness that effective CMD diagnostics are largely inaccessible to most patients,” Dr. Robert Takla, chief medical officer at Genetesis, said in a release. “More broadly, the FDA’s willingness to grant us two back-to-back breakthrough designations…illustrates the need for a new paradigm in cardiac imaging.”
To qualify for breakthrough device designation, a device must address an unmet clinical need in the “effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions.”
The goal of the program is to provide patients and providers with timely access to breakthrough treatments by accelerating their development, assessment and review, while maintaining regulatory standards for pre-market approval.
Annually, as many as 4 million patients in the United States are believed to present with ischemia, or inadequate blood supply to the heart, without evidence of blocked coronary arteries, a condition broadly known as INOCA.
Patients living with CMD represent one of the most common subgroups of this population, and these patients have been shown to suffer from substantially higher rates of hospitalization and subsequent cardiovascular disease progression.
The FDA’s decision rested in part on the submission of preliminary findings from the company’s MICRO trial, Genetesis said. That effort was supported in large part by Cincinnati-based Christ Hospital, whose participation helped to identify a majority of the patients that participated in the study.
Early data from MICRO has been submitted as an abstract to the European Society of Cardiology national meeting, the company said.
Genetesis, founded in 2013, has raised $40 million to date, backed by an investor pool that includes Cuban and Austin-based Mithril Capital, a venture firm co-founded by billionaire Peter Thiel, as well as locally based CincyTech, among others. That ranks it as the region's 19th-best funded startup.
The company most recently in January beefed up its executive team to prep for its upcoming commercialization efforts.
