Ultromics Granted FDA Breakthrough Device Designation for AI-enhanced Cardiac Amyloidosis Detection

April 27, 2023 — Ultromics, a leader in the field of artificial intelligence-powered diagnostics for heart failure, has been granted FDA Breakthrough Device Status for its AI-enhanced platform for detecting cardiac amyloidosis. 

The platform, EchoGo Amyloidosis, uses artificial intelligence to analyze echocardiograms and detect the presence of cardiac amyloidosis, a condition caused by deposits of abnormal proteins in the heart tissue, using only a single commonly acquired ultrasound view of the heart. 

The novel technology is designed to address the unmet need for earlier diagnosis of amyloidosis patients, which otherwise may go unnoticed until the disease has advanced, delaying treatment, and adversely impacting patient outcomes. 

Cardiac amyloidosis is a heterogeneous disease that can be difficult to diagnose, often requiring specialized expertise and testing. The disease is subclassified based on the specific protein involved, with the major subtypes being transthyretin amyloidosis (ATTR cardiac amyloidosis), caused by misfolding of the transthyretin protein, and a rarer form called light chain amyloidosis (AL cardiac amyloidosis), caused by accumulation of immunoglobulin light chains. 

"Receiving a breakthrough designation for EchoGo Amyloidosis, emphasizes the importance of this innovation," said Dr Ross Upton, CEO and Founder of Ultromics. "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 recognizes novel innovations that demonstrate the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases. This is an important milestone for the field of healthcare overall, and more saliently, a giant leap forward for amyloidosis patients which suffer a dismal 5-year mortality of 44%-65% 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 with support from Janssen Biotech, Inc., part of the Janssen Pharmaceutical Companies of Johnson & Johnson. The company is preparing regulatory submissions for the U.S., and the device could be approved for commercialization as soon as early 2024. 

"While treatments exist to help slow or halt the progression of cardiac Amyloidosis, underdiagnosis in the early stages of disease is a huge challenge," said Najat Khan, Ph.D., Chief Data Science Officer and Global Head, Strategy & Operations at Janssen Research & Development, LLC. "When applied to routine tests like echocardiograms, artificial intelligence is demonstrating exciting potential to help facilitate earlier disease detection – with the goal of connecting patients with treatment sooner and, ultimately, driving better health outcomes." 

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 Authorization in 2023. EchoGo Amyloidosis is currently in development with the algorithm as a candidate for FDA medical device submission. 

For more information: www.ultromics.com