Liver Nodularity LLC has developed a noninvasive method for obtaining a virtual liver biopsy by measuring the amount of liver surface nodularity (LSN) on routine computed tomography (CT) images that are from any manufacturer or model.
Over 1 billion people worldwide have chronic liver disease (CLD), and many will progress to cirrhosis leading to liver cancer, liver failure, and death. A liver biopsy is used to stage CLD but is invasive with risks of bleeding, infection, and even death. A widely available noninvasive method for staging CLD is needed.
The liver surface becomes more nodular (bumpy) with higher stages of CLD. CT imaging is widely available and frequently used in patients with CLD and cirrhosis. We have developed a noninvasive method to measure liver surface nodularity (LSN) on CT images to obtain a Liver Score. The Liver Score is designed to be used to noninvasively stage CLD and cirrhosis, though the technique is pending FDA and CE approval before it can be used outside of a clinical trial.
The Liver Surface Nodularity (LSN) software was written in C++ as a PC-based platform designed for use by radiologists. The LSN software was converted into a plugin for Osirix MD, an FDA-cleared image viewer, providing a mechanism for us to seek FDA 510(k) and CE clearance. The software has been validated in multiple clinical studies, is highly accurate and reproducible, is technically easy to perform (2 minutes per patient), works with CT images from any CT scanner, and has a 0% technical failure rate.
What's your Liver Score?
10% of Americans have chronic liver disease, and 1 million have cirrhosis. There are no other CT methods with sufficient accuracy to stage chronic liver disease or cirrhosis.
Liver Nodularity LLC is the sole owner and exclusive licensee of 1 accepted patent in Japan and patents pending in the U.S. and European Union.
Fully functional and distributable research software, extensive testing by 10 luminary sites, multiple patents pending on the intellectual property, multiple published validation studies, multiple successful grants, and a president with significant clinical research/trial and grant writing experience.
Mayo Clinic Jacksonville
Mount Sinai New York
University of Alabama at Birmingham
University of California at San Diego
University of Mississippi Medical Center
RSNA in 2015 - $3,000
RSNA in 2015 - $50,000
RSNA in 2016 - $30,000
NIH STTR phase 1 in 2016 - $225,000
RSNA in 2018 - $3,000
Institutional support from other luminary sites. Contact us (see below) for details.
GO TO MARKET STRATEGY
We have partnered with commercial software engineers to submit a FDA 510(k) application by the end of 2018. Once we have FDA 510(k) clearance, we will directly make it commercial with a marketing and sales team. As we partner with larger imaging companies (e.g. Canon Medical), we will license the software to the vendors and have our software engineers adapt the LSN software to their platforms.
HOW DO YOU MAKE MONEY?
We will sell the FDA 510(k) and CE cleared software product to radiology practices and hospitals in the U.S., Europe, and Japan that see patients with chronic liver disease. The radiology practices and hospital then make revenue by increasing the number of CT scans and charging a fee for 3D image processing.
There is no other CT imaging algorithm or method that competes with the LSN score. What is available are ultrasound and magnetic resonance (MR) elastography techniques that measure liver stiffness. Ultrasound elastography is well established but has limited accuracy and a technical failure rate around 5-10%. MR Elastography can assess the entire liver and has higher accuracy but is not as well established.