Heart Test Labs Inc. (HTL) has raised about $12 million in its most recent funding round. The company is developing Myovista, an electrocardiography device, that it said could potentially fill the "diagnostic gap" in heart disease. HTL is currently vying for approval of Myovista in Europe.

"We're on the cusp of going to market [in Europe]," Andrew Simpson, executive chairman of Westlake, Texas-based HTL, told Medical Device Daily. "Fingers crossed, we expect to get CE mark approval this quarter. This round is going to be used to build up the sales capacity of the company to support revenues. The funding is also going to support the ongoing clinical work as well as further product development."

Simpson said the company was also seeking FDA approval, but that could come later.

HTL was formed in 2009 and including the most recent funding round, the company has raised $33 million since inception.

"All of that money has been raised from private investors," he said. "Some of our investors invested in 2009 and 2010 and they continue to be very supportive in multiple rounds."

If approved, Myovista could help provide a non-invasive, low cost screening to identify asymptomatic patients before an adverse cardiovascular event occurs. Existing ECG technology is generally not considered effective for use on asymptomatic patients. The U.S. Preventive Services Taskforce and other health care bodies around the world recommend against screening with resting or exercise for the prediction of coronary heart disease events in asymptomatic adults at low risk for coronary heart disease events. Myovista uses standard 12-lead resting ECG protocols and provides an ECG test incorporating interpretive analysis that can assist a physician in identifying heart disease at an early stage. HTL said that electrophysiological signals at the cellular level of myocardium are related to specific patterns on the Myovista device.

"Because it's an ECG it's a low-cost technology and that means physicians can use it much more easily for screening purposes," Simpson said.

HTL is involved in several studies of the device. In Dec. of 2015, the company announced the clinical study of its Myovista device by Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center. The 200-patient study sought to compare the results of the Myovista test to an established testing method, cardiac computed tomography angiography.

The market for Myovista and cardiac monitoring devices is projected to reach $28 billion by 2021 from $22.19 billion in 2016, at a change of growth rate of 4.8 percent, according to a report from Markets and Markets.

Although HTL said it doesn't have any direct competitors, companies like Irhythm Technologies Inc. are seeking to change the cardio-diagnostics paradigm. The San Francisco-based company has developed Zio, a patch-like device worn by the patient for up to 14 days and records every single heartbeat of information that the person has. Simpson said the market is ripe for new cardiovascular diagnostic technologies.

"How do most people find out they have heart disease? They have an adverse event," Simpson said. "There are lots of screening tests in lots of areas – such as cancer – that are highly effective at catching things at an early age, but there is nothing effective in heart disease."

He added HTL is very hopeful it could catch people at an early stage before an event and that could save the health care industry billions of dollars each year.