510(k) clearance positions product for marketing in the United States to support early detection of liver disease
OXFORD, United Kingdom, Nov. 12, 2015 /PRNewswire/ -- Perspectum Diagnostics, a global leader in the development of technologies to diagnose and measure liver disease based on magnetic resonance imaging, today announced that its LiverMultiScan imaging device, which can detect early liver disease using magnetic resonance imaging (MRI), has been given 510(k) clearance from the U.S. Food and Drug Administration (FDA). The platform is now positioned for marketing in the United States and set for a formal launch at the 2015 American Association for the Study of Liver Disease (AASLD) Liver Meeting November 13-17, 2015 in San Francisco.
LiverMultiscan was introduced in Europe and the U.S. as a research device in 2014, and is now installed in leading medical centers on three continents. In addition, LiverMultiscan has important applications in clinical research for therapies targeting treatment of a range of liver diseases. The technology is currently being used to assess primary endpoints in clinical trials for investigational therapies to treat non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH).
Colonel Stephen A. Harrison, MD, FACP, FAASLD, Medical Corps USA, who is conducting these trials at San Antonio Military Medical Centre, said, "LiverMultiScan is a novel non-invasive imaging technology with the potential to dramatically change the way we approach diagnosis of liver diseases such as NAFLD. Recent published data suggest that this modality can rapidly differentiate normal liver from fibrotic NASH and then accurately predict outcomes based on the liver, inflammation, fibrosis (LIF) score. Further studies are warranted to confirm these findings, but we are excited about the possibilities this imaging modality offers for the future in NASH diagnostics."
Liver disease affects more than 15% of people in the U.S. and 10% of all people in the U.K., and represents a significant area of unmet need in global healthcare. Obesity is a major risk factor for non-alcoholic fatty liver disease (NAFLD). The World Health Organisation predicts that in 2015 the number of obese people in the world will rise to 700 million.
Used in the clinical management of patients with chronic liver disease, LiverMultiScan is the only imaging test cleared to detect early-stage liver disease. The technology offers a quantitative liver assessment in a safe, non-invasive 15-minute MRI scan. Analysis is based on assessment of native properties of liver tissue, accurate measurement of liver fat and other metrics without the need for additional diagnostic technologies or contrast agents.
Perspectum Diagnostics also recently announced the closing of a $5m round of private equity financing. Investors include the University of Oxford and Oxford University Hospitals NHS Trust.
"This has been a very important year for Perspectum. We have expanded our global footprint with installations of LiverMultiScan in many new treatment and research centers around the world and we continue to make great progress in our strategy for global expansion," said Dr. Rajarshi Banerjee, CEO of Perspectum Diagnostics. "Our successful financing and FDA clearance represent strong validation of our technology, and we continue to be very pleased that leading investors recognize the potential of our business model to improve patient care and play an essential role in clinical research to develop new therapies to treat liver disease."
About Liver Disease
NAFLD (non-alcoholic fatty liver disease) is the most common liver problem in the western world with 20-30% of the population affected, the vast majority of whom are undiagnosed. Both obesity and type 2 diabetes are regarded as global epidemics and are established risk factors for liver disease and metabolic syndrome. The ability to accurately assess changes in liver fat, fibrosis and inflammation is essential to support early diagnosis of liver disease and improve outcomes.
LiverMultiScan is the only imaging service cleared to aid in the diagnosis of early liver disease. It utilizes quantitative MR methods, similar to recent developments in cancer and cardiac imaging, and has been shown to predict clinical outcomes for patients with liver disease. This technology provides a highly detailed map of the whole liver, making it possible to precisely identify regions of disease. Installed in leading hospitals in the U.S., EU and Africa, the technology is also widely used in clinical research programs targeting new therapies to treat liver disease. This scalable technology enables as many as six patients to be tested in an hour using one MR system, with a 95-97% success rate. The technology can help reduce patient turnaround time and the need for retesting associated with other methods.
About Perspectum Diagnostics
Perspectum Diagnostics is leading the medical imaging industry through use of medical resonance imaging (MRI) to accurately detect and measure liver disease. The founders of Perspectum are world-renowned experts in MRI who have developed and patented an innovative non-invasive assessment method based on MR imaging that does not require contrast. Perspectum's proprietary software platform, LiverMultiScan, supports a rapid and precise evaluation by providing a highly detailed map of the whole liver showing specific regions of disease. This technology can play an important role in the diagnosis of liver disease and in the evaluation of patients receiving treatment for liver disease, and can help many patients avoid the need for painful and time-consuming surgical liver biopsies. The technology also has potential applications in the treatment of gallbladder and pancreatic disease, including precancerous and cancerous states. For more information, visit http://perspectum-diagnostics.com/.
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