TORONTO – Vancouver, B.C.-based Sonic Incytes Medical Corp. is giving MRI a run for its money assessing chronic liver disease following a successful, CA$3.5 (US$2.6 million) seed round. That brings total funding to CA$8 million (US$5.92 million) for a hand-held ultrasound device that quantifies liver disease using 3D tissue sampling and analysis in approximately five minutes in a doctor’s office.
“This financing will go a long way in helping us redefine the standard of care in quantifying fatty liver disease (FLD),” Sonic Incytes CEO George Aliphtiras told BioWorld. “We’ll be using the money for some early market development activities like customer development and leveraging key opinion leaders who will be using our technology in various locations in North America.”
Beefing up the standard of care
Approximately 1 in 4 persons worldwide has FLD, a number that rises to 1 in 3 Americans because of the prevalence of diabetes and obesity, said Aliphtiras. It’s an “emerging global health crisis” but also an opportunity to improve on biopsy, MRI and ultrasound used to diagnose FLD, tools that can be expensive, invasive and time-consuming.
Sonic Incytes’ technology surpasses MRI in two ways, said Aliphtiras. It measures physical properties of FLD such as underlying tissue stiffness, an indicator of the presence of fibrosis and cancer, said Aliphtiras. But the delivery model is also key: a personal mobile-tablet and a hand-held ultrasound probe that will make those measurements in a standard 15-minute doctor’s appointment.
“Doctors don’t normally have in-office solutions for diagnosing liver disease,” said Aliphtiras. “Our device will be made broadly available to practicing physcians without the rigorous training in ultrasound normally required and allow them to examine patients with either early or late stage liver disease.”
For the patient it is as simple as lying on the Sonic Incytes’ activation pad, Aliphtiras added. The physician measures the amount of liver fat by sweeping a probe across the rib area above where the liver resides and uploads that information to a hand-held tablet that processes the data set into numeric outputs.
“The results are then displayed, including quantitative outputs on how much fat and how much fibrosis you may have,” said Aliphtiras. A healthy liver can have as much as 5% fat. Ten percent to 20% and a formal diagnosis of FLD is made. Thirty percent fat content or higher, and your doctor becomes genuinely alarmed.
Sonic Incytes’ ambitions don’t stop at augmenting existing tools to prevent FLD from getting to that stage, said Aliphtiras. They want to disrupt the FLD standard of care by replacing biopsy and MRI, said Aliphtiras, making its tool not only more precise and accurate but available in both outpatient and primary care settings, too.
“This technology is redefining what patients will experience from early onset to late diagnosis of fatty liver disease,” said Aliphtiras. “This will help end users triage patients and ultimately change the way they manage patient care.”
It’s not just about the fat
The funding announcement includes CA$1 million (US$740,000) from Genome BC made solely on the basis of the positive health outcomes expected from the Sonic Incytes technology. Part of the overall funding has been dedicated to an initial clinical study of nearly 150 participants and to a second clinical study this year of 100 participants.
The diagnostics tool is licensed under an agreement with the University of British Columbia where the idea began and where Aliphtiras as an entrepreneurial resident began developing a business plan in 2016. Well beyond the prototype stage, the device has been submitted to the FDA for review for a possible clearance by the end of 2020.
It may not end there. Aliphtiras said the diagnostic and measurement tool will likely have an application in weight loss settings as well. Cutting excess fat is important, but it’s not everything. “Whenever you go for any dietary intervention or lifestyle change the real question is are you changing your metabolic system. Your liver is actually the cornerstone of that.”