Oxford-based Ultromics has been granted FDA Breakthrough Device Status for its AI-enhanced platform for detecting stroke risk factor cardiac amyloidosis.
What is cardiac amyloidosis?
Cardiac amyloidosis, also known as stiff heart syndrome, is a condition caused by amyloid deposits replacing normal heart muscle. It is also the most common form of restrictive cardiomyopathy.
Cardiac amyloidosis & stroke
A 2021 study published in the journal ‘Stroke’ found that in a large heterogenous cohort of elderly patients, cardiac amyloidosis was associated with a 2.5-fold heightened risk of ischaemic stroke.
The EchoGo Amyloidosis platform uses artificial intelligence to analyse echocardiograms and detect the presence of cardiac amyloidosis by using only a single commonly acquired ultrasound view of the heart.
However, cardiac amyloidosis is a heterogeneous disease that can be difficult to diagnosed and often needs specialised expertise and testing.
The disease is sub classified depending on the specific protein involved, the major subtypes being transthyretin amyloidosis (ATTR cardiac amyloidosis_, which is caused by misfiling of the transthyretin protein, and a rarer form known as light chain amyloidosis (AL cardiac amyloidosis), which is caused by the accumulation of immunoglobulin light chains.
Ross Upton, CEO and founder of Ultromics, says: “Receiving a breakthrough designation for EchoGo Amyloidosis, emphasises the importance of this innovation.
”This is our second breakthrough designation and brings us one step closer to achieving our goal of providing earlier and more accurate diagnosis for this debilitating, underdiagnosed disease. We are excited to continue working with our partners to bring this technology to market and help improve outcomes for patients.”
FDA Breakthrough Device Designation recognises novel innovations which demonstrate the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases.
Timing is of essence with cardiac amyloidosis detection as amyloidosis patients suffer a 5-year mortality rate of 44 – 65 per cent after diagnosis, if not caught early enough.
The product, intended as a module within Ultromics’ EchoGo Platform, has been developed with data from several leading clinical collaborators and also with support from Janssen Biotech, Inc., part of the Janssen Pharmaceutical Companies of Johnson & Johnson.
Ultromics is preparing for regulatory submissions for the U.S and the device could be approved for commercialisation as soon as early 2024.
Ultromics’ Amyloidosis platform is the company’s second technology to receive FDA Breakthrough Device Designation within the last year. Its HFpEF device, EchoGo Heart Failure received Breakthrough Device Designation in 2022 and Marketing Authorisation in 2023.
EchoGo Amyloidosis is currently in development with the algorithm as a candidate for FDA medical device submission.
