Hepatica is designed to leverage non-invasive quantitative multiparametric MRI technology to facilitate liver health assessment
Hepatica surgical decision support tool for liver cancer. (Credit: Business Wire.)
UK-based biotechnology firm Perspectum has secured the US Food and Drug Administration (FDA) 510(k) approval for its precision oncology decision support tool for liver cancer, dubbed Hepatica.
Hepatica leverages non-invasive quantitative multiparametric MRI technology to facilitate liver health assessment based on AI-driven liver segmentation, along with unique biomarkers for hepatic fibro-inflammation and fat.
The tool makes use of AI to delineate the liver and measures regional volumes saves over 20 minutes of pre-operative radiology time per case.
HHFT consultant general and hepatobiliary surgeon Myrddin Rees said: “As a hepato-biliary surgeon with over 30 years of experience operating on the liver I am thrilled that Hepatica is now cleared for clinical use. The missing element in all our current diagnostic, non-invasive imaging is an accurate assessment of the quality of the liver parenchyma.
“Hepatica provides the surgeon with a measure of liver well-being that allows us to push the boundaries on the one hand whilst avoiding the removal of inappropriate liver volume on the other. This work is a significant advance in our quest to treat more patients with liver disease whilst armed with the knowledge of what can be achieved safely.”
According to the company, surgery is one of the important treatment options for primary or secondary liver cancer. The success of surgery depends on the volume and health of the remaining liver, which is impacted by any underlying chronic liver disease (CLD).
Accurate pre-surgical evaluation of liver health is an urgent requirement to improve the outcomes for patients, said the company.
A UK-based study on 143 surgical candidates showed that Hepatica could effectively identify patients at risk of poor outcomes from surgery and a longer stay in hospital.
The study results demonstrated superior estimated future liver remnant combined with an assessment of underlying fibro-inflammation to determine the effectiveness of the tool.
With Hepatica, healthcare teams are enabled to make more informed pre-operative decisions for improved post-operative outcomes and cost-savings.
Perspectum said that its Hepatica will easily integrate into the clinical workflow and offer a simple, patient-friendly report through cloud-based service.
University of California, San Diego radiology professor Claude Sirlin said: “Hepatica is an advanced oncology tool that provides objective information to guide personalised clinical management.
“It is an excellent application of smart imaging and Artificial Intelligence in medicine, and I look forward to seeing how it can be used in a variety of indications to improve clinical care.”