It is estimated that about 4.5 million adults in the United States suffer from liver disease, and that number is expected to increase as nonalcoholic fatty liver disease is on the rise.
Characterized by excess fat in the liver, it can lead to inflammation or scarring over time. Because the disease often has no symptoms, it often goes undiagnosed. Currently, the gold standard for diagnosis is a biopsy, but companies are also working on the development of non-invasive screening tools to catch the disease earlier.
One of those startups is Oncoustics, which applies AI to raw RF ultrasound signals to differentiate healthy liver tissue from diseased tissue by measuring the acoustic properties of the tissues. A panel of judges selected the startup as the winner of the Pitch Perfect competition at MedCity Invest Pop Health.
Oncoustics hopes to transform ultrasound into better point-of-care screening tools that are less invasive and less expensive than current alternatives. They work by sending sound waves, which then bounce off the fabric and are converted into a grayscale image.
However, Oncoustics doesn’t just analyze the image itself. It also collects the raw signal, including information that was not used to generate the image. He plans to use this additional information to reveal new biomarkers and quickly differentiate healthy from diseased tissue.
âThere is a huge amount of signals that are being rejected and we are collecting all of that,â CEO Beth Rogozinski said in an interview with MedCity News.
The Toronto-based startup was founded in 2018 by Ahmed El Kaffas, who worked with ultrasound data while earning his doctorate in medical biophysics at Sunnybrook Research Institute. He was studying the acoustic properties of tissues to monitor cancer treatments, when he and Rogozinski identified a significant unmet need in the detection of liver fibrosis.
âWe are initially focusing on the liver because of the high unmet need,â she said. âThe liver is an easy organ to image for ultrasound systems, number one and number two, there is this huge and growing need around liver disease. “
For starters, Oncoustics focuses on categorizing liver fibrosis using a clinical decision support tool, which means that a healthcare professional will ultimately make the final decision. The company is working on a 510 (k) submission for the Food and Drug Administration and hopes to start marketing its product by 2023. Rogozinski, former product manager for Pear Therapeutics, is no stranger to the process, as she led the digital health startup through the process of its first authorization.
The good news is that, if caught early, nonalcoholic fatty liver disease can be reversible through dietary changes or weight loss. Many pharmaceutical companies are also working to develop treatments for non-alcoholic steatohepatitis, a form of non-alcoholic fatty liver disease.