FDA Clearance for Hepatica, Perspectum’s Surgical Decision Support Tool for Liver Cancer

DALLAS–(BUSINESS WIRE)–Jan 28, 2021–
Perspectum announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for Hepatica, a precision oncology decision support tool for liver cancer.
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FDA Clearance for Hepatica, Perspectum’s Surgical Decision Support Tool for Liver Cancer (Photo: Business Wire)
Each year, around 200,000 Americans are diagnosed with primary or secondary liver cancer, with surgery as one of the key treatment options. The success of surgery relies on the volume and health of the remaining liver, which is impacted by any underlying chronic liver disease (CLD). Fatty liver disease, chronic viral hepatitis B and C as well as alcoholic liver disease affect nearly 100 million Americans, with prevalence increasing. Accurate pre-surgical assessment of liver health is therefore urgently needed to improve the outcomes for patients.
Hepatica uses non-invasive quantitative multiparametric MRI to provide a liver health assessment based on AI-driven liver segmentation together with proprietary biomarkers for hepatic fibro-inflammation and fat. Using AI to delineate the liver and calculate regional volumes saves over 20 minutes of pre-operative radiology time per case.
Initial results from UK-based study on 143 surgical candidates showed that by combining estimated future liver remnant with an assessment of underlying fibro-inflammation, Hepatica could effectively identify patients at risk of poor outcomes from surgery and a longer stay in hospital. This information enables tumour boards and multidisciplinary teams to make more informed pre-operative decisions to improve post-operative outcomes for patients, translating to cost-savings in associated care.
Mr Myrddin Rees, Consultant General and Hepatobiliary Surgeon at HHFT commented, “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.”
Hepatica seamlessly integrates into the clinical workflow and provides a simple, patient-friendly report via a cloud-based service.
“Hepatica is an advanced oncology tool that provides objective information to guide personalized clinical management,” said Professor Claude Sirlin, Professor of Radiology at University of California, San Diego. “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.”
Notes to Editors
About Hepatica
Hepatica is a precision oncology tool for clinical and surgical decision support tool based on non-invasive quantitative multiparametric MRI. It identifies high risk patients and enables more informed preoperative decision making, therefore improving post-operative outcomes. Hepatica has demonstrated utility in identifying patients at risk of poor outcomes, with the potential to inform surgical planning and realize significant cost savings through lowering the post-surgical complication rate, associated in-patient hospital stay and reducing time required from radiologists.
About Perspectum
Perspectum delivers cutting-edge digital technologies that help clinicians provide better care for patients with liver disease, diabetes and cancer. With a strong focus on precision medicine using advanced imaging and genetics, our vision is to empower patients and clinicians through quantitative assessments of health enabling early detection, diagnosis, and targeted treatment. With a diverse team of physicians, biomedical scientists, engineers and technologists, Perspectum offers a way to manage complex health problems at scale. For more information, visit perspectum.com.
View source version on businesswire.com:https://www.businesswire.com/news/home/20210128005860/en/
CONTACT: Jasmin Hounsell,Jasmin.Hounsell@perspectum.com
Cell: +1.469.390.2122
KEYWORD: TEXAS UNITED STATES NORTH AMERICA
INDUSTRY KEYWORD: ONCOLOGY MEDICAL DEVICES HEALTH SURGERY CLINICAL TRIALS BIOTECHNOLOGY
SOURCE: Perspectum
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PUB: 01/28/2021 11:33 AM/DISC: 01/28/2021 11:33 AM
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