Anumana will pursue a clinical trial with the goal of obtaining a de novo AI clearance from the FDA as well as approvals in Europe and Japan.
The heart-focused artificial intelligence company Anumana is looking to break new ground for its algorithms through a partnership with Pfizer. They plan to develop programs that can help diagnose cases of cardiac amyloidosis, where misfolded proteins build up around the tissue.
Anumana has staked a claim on the idea that there is a wealth of data still to be mined from reading into the electrical activity of the heart. The repeated changes in voltage across the cardiac muscle that drive each heartbeat have been used to track irregular rhythms and overall heart function, but Anumana aims to use electrocardiograms to gain a clearer view into the organ’s structure.
It believes its AI can also spot the signs of a weakening ventricle, as well as atherosclerotic buildups of plaque in blood vessel walls and too-high levels of potassium, all hidden within the peaks and valleys of ECG readings.
Originally launched in 2021 as a joint venture between nference and the Mayo Clinic, Anumana will now work with Pfizer on a multiyear research project, and will pursue a clinical trial with the goal of obtaining a de novo AI clearance from the FDA, as well as approvals in Europe and Japan.
Cardiac amyloidosis can lead to heart failure by making the heart walls stiffen over time. Traditionally, the condition has been largely misdiagnosed, as it produces a variety of seemingly unrelated symptoms affecting the kidneys, gastrointestinal tract, joints and breathing.
“The challenge in diagnosing cardiac amyloidosis can prevent patients from getting treatment while the disease continues to progress,” David McMullin, chief business officer of Anumana, said in a release.
Pfizer, meanwhile, has been pursuing treatments to address the thickening of the heart muscle that can come with the condition. Its recent blockbusters Vyndaqel and Vyndamax were approved in May 2019 to treat cardiomyopathy caused by transthyretin-mediated amyloidosis, or ATTR, and the drugmaker has been working to raise awareness of the disease.
The company previously estimated that in the year following their launch, diagnosis rates climbed from 2% to at least 21%, which still leaves a lot of space to grow. With list prices of $225,000 per year, Vyndaqel and Vyndamax brought in over $1.3 billion in 2020.