Oncoustics creates advanced AI solutions for low cost, non-invasive surveillance, diagnostics, and treatment monitoring of diseases with high unmet clinical need. By applying AI to raw ultrasound signals, Oncoustics rapidly differentiates healthy versus diseased tissues via novel acoustic biomarkers for virtual biopsy tools, surgical guidance and drug development. Our prospectively collected >4M+ pieces of data is the largest RF signal dataset in the world, creating an inimitable position. Initially targeting liver disease, a $60B+ global diagnostic market ¹ , Oncoustics is currently filing FDA submissions for the OnX liver assessment solution which has been introduced to over 100 clinics and hundreds of key opinion leaders (KOLs) in hepatology, gastroenterology and primary care globally. Several follow-on liver products are in development.

The Oncoustics solutions can work on any anatomical areas of the body that ultrasound can image and we have datasets already in prostate cancer, kidney, thyroid and women’s health. We’re focusing initially on liver diseases since there is a growing epidemic of liver diseases and no existing inexpensive or point of care way to detect, diagnose and stage these disorders. Over 2 billion people globally have or are at risk for structural liver disease ² and as this disease is often asymptomatic until it reaches very advanced stages, most of them don’t know it. The epidemic rise in liver disease is being driven by the obesity and diabetes epidemics which are causing a rise Metabolic-Associated Steatotic Liver Disease (MASLD), previously known as non-alcoholic fatty liver disease or NAFLD. MASLD is the most common chronic liver disease today and UCLA health estimates that up to 46% of the US population has or is at risk of MASLD ³ . Canada is not far behind. Structural liver diseases such as liver fat and fibrosis are expected to drive most liver-related cancers, mortalities and transplants in the next decade. MASLD can also exacerbate other behavioral health conditions like diabetes and cardiovascular disease ⁴. This indicates that if a patient has MASLD, their risk for all-cause mortality goes up. Current preventative approaches to catch and diagnose liver disease early are complex and time consuming, with several appointments and specialists involved. It’s expensive & minimally available, often involving high-end imaging such as MRI or highly invasive biopsies. There is a global need for a fast, inexpensive, non-invasive point of care solution, like the OnX Liver assessment Solution to address this unmet clinical need. Many clinics, provider networks and clinicians have already expressed interest in using the OnX for staging and diagnosing patients in their practices. The OnX has been introduced to over 100 clinics and hundreds of KOLs globally all of whom are interested in deploying this solution within their clinics and/or seeing this deployed further downstream. (IE Hepatologists have told us they’d like to see the OnX in primary care so that they are able to focus more exclusively on patients in highest need.) The OnX has been deployed to 10+ clinics for global data collections and introduced widely to biopharma and OEM partners. Several partnerships and collaborations are in development and Oncoustics is initiating collaborative studies with pharma partners.

For this project, we’re building on the OnX platform and advancing the technology to address other structural diseases of the liver with a specific focus on liver inflammation. This project would advance the OnX clinical labels, market reach and opportunities for corporate partnerships with additional pharma companies and contract research organizations (CROs) engaged in developing drugs and other treatments for liver diseases like DILI, MASLD and MASH, (Metabolic dysfunction-associated steatohepatitis) and cancers of the liver and beyond.

Liver inflammation, also known as hepatitis, is swelling and damage to the liver tissues. It can be acute (short-term) or chronic (long-term) and is caused by various factors including viruses, alcohol, toxins, over the counter and pharmaceutical drugs, and autoimmune conditions ⁵ . Hepatitis is detected and diagnosed through several methods, including clinically through physical exams and blood tests. Both of these methods miss early stages of disease and are better used in later stages and/or for specific viral factors like Hepatitis virus type B (HBV). Radiology imaging tests, even those with strong correlations for diagnosing liver disease like the MRI cT1*, (Iron corrected T1) is not accepted or widely available for steatohepatitis. Even though used, these imaging exams require expensive and high-end radiology devices, often found only in hospitals and specialty trained technologists and radiologists. No imaging exams are specifically validated for inflammation. Liver biopsy is the reference standard to detect and stage liver inflammation, but this is again expensive and invasive and includes a small but known risk of injury and/or death. Given the expense, lack of availability, and risks these tests are reserved for later in the patient journey.

And yet, early detection of liver inflammation is crucial, as many people may not experience noticeable symptoms initially. Ongoing inflammation may result in progressive fibrosis that is associated with an increased risk of liver-related outcomes. When symptoms do appear, they may include fatigue, nausea, abdominal pain, jaundice, and dark urine ⁶ . As with the Oncoustics initial solution for detecting liver steatosis and fibrosis, there is a need and demand for easy point of care liver inflammation evaluation that can be done without the need for blood tests, biopsy or transferring to radiology departments.