Creavo launches largest US study of its kind

Creavo launches largest US study of its kind

Date: July 27, 2018

A new cardiac diagnostic device aimed at helping physicians rule out active ischemia in patients presenting to the emergency department (ED) with chest pain is being trialled in a study at five of the most respected research facilities in the United States (Mayo Clinic, Rochester, MN; Baylor University, Houston, TX; Vanderbilt University, Nashville, TN; University of Cincinnati, OH; and Wake Forest University, Winston-Salem, NC).

The device, developed by Creavo Medical Technologies Ltd (Creavo) a UK-based privately-held medical device company, is a mobile medical magnetometer which can be used at a patient’s bedside to measure and report electromagnetic fluctuations caused by heart activity.

Approximately 720 patients will be enrolled throughout the trial, which is the largest magnetocardiography (MCG) trial ever to take place in the United States and is scheduled to be completed by mid-2019.

Gregory J. Fermann, MD, Professor, Executive Vice Chairman and Director of the Clinical Trials Centre at the University of Cincinnati said: “Each year, 8 to 10 million patients complaining of chest pain present to an emergency department (ED) in the United States”.  Dr. Fermann serves as the US Chief Investigator for the MAGNET ACS-US (ClinicalTrials.gov identifier: NCT 03546933) trial which is being coordinated at the University of Cincinnati, Cincinnati, OH, USA.

“The ability to quickly risk stratify and safely discharge ED patients presenting with symptoms consistent with chest pain of cardiac origin is critically important to the overall flow of patients through crowded Emergency Departments. This device has the potential to become an essential tool in the rapid evaluation of these patients.”

“On behalf of the entire MAGNET ACS-US investigative team, I am excited to report that we are open to recruitment of Emergency Department (ED) patients.”

Steve Parker, Chief Executive Officer at Creavo said: “Our device has the potential to tackle a global unmet need. Non-ischemic chest pain patients place a huge strain on emergency departments as the current rule-out triage process of electrocardiograms and blood biomarker tests can take a number of hours. Our device is designed to rapidly aid physicians with the decision to rule out acute coronary syndrome by performing a non-invasive five-minute scan, freeing up resources and bed space.

“We’ve conducted extensive research into the use of MCG in UK emergency departments and are pleased to be taking our research further afield into the US.”

Commenting on the technology behind the device, Professor Ben Varcoe, Chief Scientific Officer at Creavo said: “MCG technology has been used in medical research since the 1960s, but historically it has been restricted to larger immobile SQUID devices which aren’t practical for emergency medical settings. Our device can be deployed directly at the patient’s bedside and uses MCG to detect abnormal patterns in the magnetic fields of the heart.”

There have been several notable achievements for Creavo in the last two years. The device received CE mark registration in Europe in November 2016 and secured 510(k) clearance as a device that measures and displays magnetic signals generated by the heart from the US Food and Drug Administration in October 2017. Following initial funding, the company raised £13.4m ($17m) in private equity funding in July 2017. The round was oversubscribed and exceeded Creavo’s funding target, reflecting strong investor support and endorsement of the company’s strategy and team.

Creavo is a University of Leeds spin-out, supported by the IKC in phase one.

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