Genetesis: Non-Invasive Detection of Cardiovascular Disease Inspired by a Grandfather’s Illness

When Peeyush Shrivastava, co-founder and CEO of Genetesis, was younger, his India-based grandfather was diagnosed with a  neurological condition and a heart condition, among other ailments. For years, his grandfather did not have access to high-quality healthcare, and given his age and condition, Shrivastava figured that any medical treatment meant to help his grandfather would be highly invasive and experimental.

Shrivastava began to seek better ways to diagnose potential cardiovascular problems for patients like his grandfather that would eventually gain the attention of a well-known tech billionaire and Cincinnati-based venture development fund, CincyTech.

THE BIRTH OF GENETESIS

Shrivastava went to Ohio State University to study biomedical science. During this time, he met his future co-founders, fellow-students Emmanuel Setegn from Ohio State and Vineet Erasala from Case Western University.

“While talking at a cookout one weekend in 2013, we were throwing ideas around about ways we could solve the problem of frequent, invasive imaging and how to make it more patient-centric. We decided to bite the bullet and founded the company there and then,” says Shrivastava.

A NEW WAY OF IMAGING

‘We were determined that, rather than trying to measure currents of the heart directly, it would be easier to measure the magnetic fields that would result from those currents, in a non-invasive way.’

— Peeyush Shrivastava, Co-founder, Genetesis

Genetesis was born.

For the first two and a half years, they had no capital and operated in idea mode, characterizing the problem, working on iterative prototyping, and designing various concepts. In time, they developed more precision around the concept of non-invasive magnetocardiography (MCG), something with which Shrivastava had some peripheral experience from working at Ohio State.

“We were determined that, rather than trying to measure currents of the heart directly, it would be easier to measure the magnetic fields that would result from those currents, in a non-invasive way,” Shrivastava said.

WHAT IS MCG?

There are currently two ways of measuring electrical activity in the heart: MCG and ECG (electrocardiography). MCG demonstrates major advantages over ECG. These advantages include no physical contact with the skin; a more holistic view of the electrical activity in the heart; and the ability to provide extra information over and above ECGs, since they can detect the magnetic field produced by currents in heart tissue.

That said, there have been challenges  with implementing an MCG system that have limited the number of applications in use today. Despite these limitations of MCG, one of its huge advantages is its ability to detect the onset of cardiovascular disease in a very early stage with high accuracy, for both acute and asymptomatic patients – and most importantly, non-invasively.

This was the potential that Shrivastava saw.

TAKING THE DREAM ONE STEP CLOSER TO REALITY

After winning a business idea competition in Buffalo, NY in 2015, the Genetesis team left their respective colleges and relocated to the city to focus on their idea full time.

As with many startups, Genetesis experienced its share of experimentation and wrong turns. Along the way, the team gained knowledge. At first, the trio was under the misconception that by simply building magnetic field-sensitive equipment, investors would come knocking. It didn’t work out that way because, in reality, the equipment itself was outdated 80s and 90s technology.

At the end of 2015, they developed a great prototype, but there were no systems in place for the back end. What’s more, the company had nearly run out of money.

In early 2016, they realized they would have to design a completely new end-to-end system – something that would make the existing technology look like a thing of the past (which it was). This new technology would be groundbreaking.

CARDIOFLUX – A BREAKTHROUGH IN NON-INVASIVE CARDIAC IMAGING

Eight million Americans go to the Emergency Department for chest pain every year; yet, in 75 percent of cases, the cause is not heart-related. The tests are lengthy, time-consuming, and expensive – not to mention the stress and anxiety faced by the patent. Finding a way to rule out acute coronary syndrome (ACS) in the early stages of admission could be game-changing.

Initial triage of potential ACS patients begins with serial ECG and biomarkers. The low sensitivity of ECG and strict cut-off criteria of new highly sensitive biomarkers typically result in many patients being sent to observation for additional, typically invasive testing. If these tests were less invasive and did not deliver high levels of ionizing radiation to the patient, they could be performed early in triage. But they are not.

This is where the new technology from Genetesis, named CardioFlux, came into its own. It is a technique as benign as ECG, but which leverages the 50 years of steady progress that MCG has made in the diagnosis of myocardial ischemia and coronary artery disease, providing demonstrated diagnostic accuracy equivalent to more invasive tests that can be applied early in triage.

The result: a clinical diagnostic pathway that can rule out ACS patients sooner, and rule in ACS patients earlier – in as little as 90 seconds. The consequence being more efficient utilization of resources and, in the latter case, improved patient outcomes.

The concept was there, but the company still needed funding.

Mark Cuban and CincyTech

The team’s breakthrough came in 2016. They contacted that billionaire, Mark Cuban, via his publicly available email address. Cuban was interested.

Cuban, who grew up in Mason, a Cincinnati suburb, was introduced to the company by David Wilbrand, author of “Seed Deals: How to Grow from Startup to Venture Capital.”  Cincinnati-based venture capital company CincyTech had vetted the CardioFlux concept and could see that CardioFlux could transform early diagnosis of ACS. CincyTech and Cuban formed a relationship during the due diligence process.  

“The CardioFlux concept showed great promise in that it was less invasive than some other imaging devices in the marketplace, and significantly reduced the amount of time needed to diagnose a potential cardiovascular problem,” said John Rice, Ph.D., managing director at CincyTech and a board member at Genetesis.

CincyTech and Cuban co-led an initial seed round, raising $1.5 million. This was followed in 2018 with a Series A, led by CincyTech, raising an additional $7.5 million. In 2020, a further $15 million was raised in Series B, led by TDK Ventures. In addition, the team raised approximately $500,000 in grants.

With this initial backing and investment, Genetesis was finally able to make its dream a reality.

FDA APPROVAL IN 2019

In 2019, the FDA cleared CardioFlux for development, and since then new technology has been incorporated, allowing for more streamlined diagnostic reports. In 2020, Medical Device Single Audit Program (MDSAP) Certification was granted, followed by international medical device certification. This was followed by numerous clinical trials, which proved the efficacy of the technology.

CardioFlux is now being used in numerous hospitals across the country, including Cleveland Clinic, Wake Forest, Ascension St. John, and William Beaumont Hospital.

“We’re now stronger than ever as a team, have weathered the storm, and are ready to make the magic happen,” said Shrivastava.

A BETTER STANDARD OF CARE

In its journey to delivering the most patient-centric and non-invasive technology on the market, Genetesis will continue to develop the CardioFlux system to be multi-model so as to reach as many patients as possible – to help those who are suffering and to do so to a better standard of care.

“We expect the technology to become more and more available at both hospitals and practice-based (outpatient) settings. You will also see the efficacy continue to be proven via peer review journals, conference presentations, and the like,”  Shrivastava said.