Ultromics, the U.K. start-up behind the world’s first outcomes driven, AI-based, ultrasound diagnostic support tool for coronary artery disease (CAD), is currently supporting multiple ongoing clinical trials.
These trials include “Rainier”, based in the U.S., and “EVAREST”, which is expanding across 35 NHS sites within the U.K.
Both trials focus on the diagnosis of coronary artery disease using Ultromics’ first product, EchoGo. Results are expected within the next few months and will be submitted to the FDA with the intention of obtaining clearance for sale within the U.S.
The U.S. based Rainier trial includes a retrospective review of 550 stress exams, as well as a total of 1,600 cardiologist reads from a variety of skill levels.
The first phase of the trial is located at Oregon Health and Science University (OHSU) and is being accomplished in conjunction with leading cardiologists Dr. Sanjiv Kaul, Director of the Knight Cardiovascular Institute, and Dr. Stephen Heitner, Director of the Hypertrophic Cardiomyopathy Clinic.
The U.K. based EVAREST trial – administered by the Oxford Cardiovascular Clinical Research Facility at the University of Oxford – has successfully entered Phase III.
Phase III will deliver recruitment of 5,000 participants across 35 NHS sites, making it one of the largest echo studies in the U.K.
This phase sees continued recruitment from Phase II, with 11 new sites and a further 15 sites currently undergoing feasibility assessment to join in early 2019. This will allow for the generalisability of stress echo protocols, machine types, operators, and patient groups across different healthcare settings.
At the conclusion of these trials, Ultromics intends to prove that EchoGo is the world’s most accurate echocardiography-based tool for the diagnosis of CAD.
Traditionally, clinicians use echocardiograms to diagnose a patient’s condition based on just a few factors, which leads to an accurate diagnosis roughly 80% of the time under the best circumstances. EchoGo, on the other hand, uses deep learning and one of the world’s largest echo image databases.
It supports clinicians by delivering greater accuracy in both sensitivity and specificity and could save healthcare payers and providers significant amounts by reducing the incidence of patients undergoing unnecessary surgical procedures.
Just as significantly, it can save lives by preventing patients with potentially fatal heart disease from being sent home.
Heart disease is the biggest killer globally. Of the 3 million stress exams performed in the US each year, it is estimated around 600,000 may be misread.
This is potentially costing the US healthcare industry billions of dollars in unnecessary additional costs.
We are determined to provide patients and providers with a reliable diagnosis, which in turn will create significant improvement to patient outcomes and savings for healthcare systems."
Ross Upton, CEO and Founder at Ultromics