Creavo Medical Technologies Ltd. was established in 2014 to commercialize technology developed at the University of Leeds professor Ben Varcoe and the company's first product to market, Corsens, is a portable platform for non-invasive detection, display, and analyses of electromagnetic fluctuations generated by the activity of the heart.
Distinguishing between ischemic heart disease (IHD) and non-cardiac chest pain remains a challenge in emergency departments. Currently, all patients presenting with chest pain are assessed with electrocardiography (ECG) and blood tests to rule out heart disease, but almost three-quarters of patients with chest pain do not have a cardiac related condition.
"ED physicians know they have a huge problem with identifying these patients and they’re looking for a medical device to help them make that triage decision," Creavo CEO Steve Parker told Medtech Insight. "What we can do with our magnetocardiography (MCG) technology is identify a normally functioning heart in a three-minute scan through clothing at the initial triage and identify the subset of patients that haven’t got a heart problem, which immediately saves the current three- to 12-hour process in [the accident and emergency department]."
The MCG scan takes a few minutes and results can help physicians to rule-out active ischemia in patients presenting with symptoms consistent with those of acute coronary syndrome. MCG technology has existed for decades but was never previously used before to triage patients, according to Creavo. "There’s a very large body of clinical evidence to show that magnetic fields have diagnostic capabilities and far more diagnostic information than traditional ECGs," Parker said.
Parker said Creavo has raised £20m in three fundraisers over the last four years, which has allowed it to build portable devices for the clinical environment, complete two proof- of-concept studies, earn CE marks and a 510(k) from US FDA for the technology, and create a manufacturing facility.
In August, Creavo completed recruiting 100 patients for a new UK study to assess MCG's ability to determine if MCG can detect damage in the hearts of those patients with a recently confirmed myocardial infarction.
Creavo is also planning another fundraising round in the second half of 2018 to support the CE mark and the launch of its next generation device in 2019. "We know we need one more funding round to make the company profitable and we’re very close to commercialization which is unusual for a medical device company that only started four years ago," Parker said. "We believe that the market opportunity for this device in the emergency medicine space is £4bn so a massive market opportunity."
In addition to ruling out ischemic heart disease, early clinical data indicates the technology can be applied to other indications including identifying patients at risk of sudden cardiac death, especially athletes Parker said. "We’re starting some proof-of-concept studies to identify those very small signals that could help people that are at a risk of cardiac death," Parker said. "There’s no tool on the market that allows you to do that. If we are successful, this could be a multimillion pound market opportunity. We really believe our devices are the birth of a whole new imaging technology."
From the editors of Clinica