The company is looking to expand to the prostate, kidney, breast and thyroid
Over 2 billion people globally are living with, or at risk for, liver disease, and many of them don’t even know it. This is being accelerated by the rise of Non Alcohol Fatty Liver, which affects up to 46% of the US population.
Yet, the current way that we catch and diagnose liver disease early on is both complex and time consuming: it involves making several appointments and seeing multiple specialists, who have to perform MRI or highly invasive biopsies.
“Current approaches for this type of tissue analysis and characterization often involve multiple referrals, high end and expensive imaging or highly invasive biopsy. Due to these costs and lack of availability, many structural and morphological diseases go undiagnosed at early stages where there’s far more options for patient interventions,” explained Beth Rogozinski, CEO of Oncoustics, a company that uses RF signals captured from ultrasounds to differentiate tissue types so patients can get an early diagnosis of their liver disease.
“There’s a wealth of information in these raw signals that is typically thrown away, and our approach reveals novel biomarkers that can be aligned with existing standards and categorization systems.”
On Thursday, the company announced the close of a $5 million seed round of funding co-led by Creative Ventures and Saltagen Ventures, along with NorthSpring Capital Partners, Fraser Kearney Capital Corp., Pallasite Ventures, and Dr. Chen Fong.
Along with the funding, the company added two new members to its board of directors: Fong, on behalf of Saltagen, and James Wang, General Partner at Creative Ventures.
“Dr. Chen Fong is a renowned radiologist, entrepreneur/investor and inductee into the Order of Canada for his contributions to medical technology innovation and philanthropy. He’s got deep expertise in healthcare and health systems and networks across North America and Asia,” said Rogozinski.
“James Wang, is an AI/ML expert and was himself a founder of a health-tech startup after working at Google X. James has extensive experience in Silicon Valley startups and technology, especially AI/ML and reinforcement learning.”
Oncoustics takes ultrasound images, as well as the acoustic data derived from the raw sound signals, and then uses artificial intelligence and machine learning to automatically differentiate tissue types, as every type of tissue in the body bounces back a unique acoustic signature, as well as to differentiate healthy versus diseased tissues. The company has amassed what it says is the largest RF signal data set in the world, with over 2 million pieces of data, to train its models.
The company’s first product is the OnX liver assessment solution, which is focused on detecting structural liver diseases including fibrosis and steatosis that can occur in all types of chronic liver disease.
With the OnX, a patient arrives and is determined to be qualified for liver screening, after which the clinician launches the OnX on an Android device and connects a portable handheld transducer. The quality check system instructs them to capture certain views of the liver, and marks the views as complete once they are acquired.
Once the clinician has submitted all of the mandatory views, they can submit the exam for review, after which the scans are uploaded to the acoustics cloud. The data is then run through a series of processing techniques to extract information, which is then fed into a series of machine learning models. Ultimately, this produces the OnX score, which tells the clinician if there is evidence of liver disease.
“Our OnX solution mines the sound in ultrasound and removes the need for any qualitative analysis and, instead, provides a quantitative and comparative score. In our current clinical workflow, a care team member can perform the exam and by the time the doctor gets in to see her patient the quantitative results can be available,” said Rogozinski.
To date, over 6,000 patients have been scanned by the OnX platform, however it is currently for investigational use only and has not been deployed into public clinical practice, though it has been deployed for studies and data collections in six public clinics.
The reason Oncoustics started with liver disease is because it’s one of the fastest growing causes of morbidity and mortality around the world, Rogozinski explained; however, the company is already expanding beyond that use case, and has developed a proof of concept solution for prostate biopsy guidance, while also developing roadmaps for other parts of the body.
“Our approach is highly scalable and works across many anatomical regions and we have clinical data on other organ indications including prostate, kidney, breast and thyroid diseases and cancers,” she said.
The company plans to use its new funding to accelerate the development of its suite of liver assessment and diagnostics solutions; that includes submitting the OnX Liver assessment solution to the FDA. The aim is to launch the OnX, start generating revenues, and expand its pipeline, as well as its pharma partnerships, while also building out its team.
“Our approach democratizes access to early diagnosis by making it much less expensive, less painful and invasive, and readily available at point of care. Our end goal is to provide early, point of care, non-invasive diagnoses, avoid unnecessary biopsy and help patients, clinicians and payers,” said Rogozinski.
“Basically, we’re looking to create a virtual biopsy tool that can be carried in your pocket.”