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Answering the worldwide need for chronic liver disease assessment and diagnosis

September 20, 2019


By Jon Gingrich and Dominique Legros


On the global backdrop of a looming worldwide epidemic of liver disease associated with the alarming prevalence of obesity and Type 2 diabetes, Echosens is dedicated to assessment of chronic liver disease and positioned for exponential growth.

Headquartered in Paris with offices in the greater Boston area, Echosens is recognized as a technology innovator with the resources and capabilities to further grow and scale its operations worldwide. The leadership team, including business executives with deep, global experience in medical devices, technology and business transformation, is deploying proven strategies to promote a platform of technologies.

Evolving from a single product to a technology platform
With this expertise of strong leadership, Echosens is evolving from a single product company – the FibroScan technology to non-invasively assess the stiffness of the liver – to an enterprise that offers a platform of products and services designed to broaden the utilization of liver disease assessment for a greater number of providers and payers in both public and private sectors. The new senior leadership is putting strategies in place and scaling the organization appropriately to enable them to further expand market penetration beyond its already impressive global footprint in 84 countries spanning five continents FibroScan, its inaugural non-invasive technology, set the stage for the development of a robust pipeline of products and roll-out of the strong technology platform. Today, FibroScan is recognized worldwide as the reference for non-invasive liver diagnosis supported with more than 2,000 medical publications and 40 guideline recommendations.

FibroScan quantifies the stiffness of the liver via proprietary and patented technique of transient elastography, a medical imaging modality that maps the elastic properties and stiffness of soft tissue. The degree of liver tissue stiffness will give diagnostic information about the presence or status of disease, which is critically important in the diagnosis of non-alcoholic fatty liver disease (NAFLD), an asymptomatic condition characterized by elevated levels of fat in the liver.

A two-minute examination with FibroScan offers a quick estimate of a patient’s liver fat content and stiffness. It can be performed by a medical assistant in the physician’s office as part of an annual exam, and is covered by Medicare, Medicaid and most insurance plans. Rapid results and test scores are analyzed by the physician, empowering health care providers (HCPs) with data and information that they can use to refer patients to a specialist or recommend additional assessments, if needed. Wider availability of FibroScan for diagnosis and monitoring will make a critical difference in the lives of individuals who face chronic liver disease.

One example of the expanded technology platform is the introduction of the FIBROVIEW™ GATEWAY, which uses combined FibroScan scores to track liver disease and integrates the results back into the patient’s electronic medical record (EMR).

Key drivers of company growth
Pioneers in the field of elastography technology, Echosens is bringing the benefits of its full range of products and services to an even greater number of physicians throughout the world and supporting their assessment and management of patients with chronic liver disease. Several key factors will contribute to this growth trajectory:

Large pharmaceutical manufacturers and the drug industry worldwide are developing drugs to treat NAFLD. Echosens acknowledges the importance of these developments and recognizes the introduction of drugs over the next three years as a catalyst for even greater opportunities. With the attention and participation of the leading pharmcos, the spotlight on assessing, diagnosing and treating liver disease will pave the way for Echosens to drive even greater utilization. In fact, FibroScan is a key component of 90 percent of the clinical trial studies now underway, and this involvement in bringing drugs to market continues to grow.

Patient Population is growing rapidly. NAFLD affects 75 to 100 million adults in the United States and is the leading cause of chronic liver disease worldwide, fueled by the rising epidemic of obesity and metabolic syndrome. Many of these patients are unaware of their condition. The growing epidemic of NAFLD and its subtype non-alcoholic steatohepatitis (NASH), a potentially progressive liver disease that can lead to cirrhosis, hepatocellular carcinoma (HCC), liver cancer, liver transplantation and death, is sounding an alarm in every corner of the globe.

According to national statistics in the United Kingdom, liver diseases have been ranked as the fifth most common cause of death. In the United States, liver diseases are recognized as the second leading cause of mortality amongst all digestive diseases.

The good news is that Echosens brings technology solutions to patients facing the health consequences of chronic liver disease, which occurs throughout the world irrespective of age, sex, region or race. The American Liver Foundation estimates that in America alone, about 100 million Americans—over 30 percent of the U.S. population—have NAFLD. This documentation of prevalence calls for early detection of NAFLD and NASH.

The obesity factor
Given the rise in adult obesity rates in the United States and worldwide, more people will begin to experience liver damage and associated health issues. In fact, obesity rates are increasing across America, with states having rates ranging from 25 to 38 percent of the adult population. Overall, about 13 percent of the world’s adult population (11 percent of men and 15 percent of women) were obese in 2016 and the worldwide prevalence of obesity nearly tripled between 1975 and 2016.

Obesity can cause severe damage to the body and contribute to not only liver disease, but also Type 2 diabetes, high blood pressure, sleep apnea and more. The rising prevalence of Type 2 diabetes and obesity, two of the main causes of NAFLD, will likely increase the demand for liver transplants, while the supply of available healthy livers dwindles. Now more than ever, there is a need for early detection and earlier treatment intervention.

The military and Department of Veterans Affairs (VA) are paying increased attention to liver disease and hepatitis C and utilizing FibroScan technology. One study found that the military experienced a 12-fold increase in the number of active military diagnosed with NAFLD and is recognized by the VA as a growing disease that requires immediate action. In fact, the Echosens contract with the VA was recently expanded to include the FibroScan 430 mini+ portable technology, improving access to non-invasive liver assessment and early detection of NAFLD.

FibroScan enhances physicians’ ability to better diagnose and monitor veterans and their families for liver disease — no matter where they receive their care. With one-third of veterans receiving their healthcare in community clinics vs. the VA Medical Centers, the addition of the FibroScan 430 mini+ provides greater access to care for these patients, thus reducing the burden of assessing liver health on veterans, their families and the VA system overall.

Strategic growth channels
Health Plans and payers are moving from a fee-for-service model to outcome-based care and value-based reimbursement models. The Echosens technology platform is designed to meet these innovative approaches and support payer programs that promote quality, cost-effective delivery of care. This includes commercial, Medicare Advantage and Medicaid sectors where it is a strategic imperative to align with priorities around better individual health, improved outcomes and cost-containment.

Hospitals and specialist offices continue to be a fertile area for Echosens growth, with hospitals and their Accountable Care Organizations (ACOs), Independent Practice Associations and other models opening opportunities for market expansion. Specialty physician practices, including endocrinologists and gastroenterologists, liver specialists, cardiologists and others continue to express strong interest in adopting the Echosens technology. Building on its presence and foundation, Echosens will continue to identify and refine these market opportunities, with anticipated growth in outpatient imaging and diagnostic facilities.

HCPs are now integrating more comprehensive liver health assessment into their practices, while also taking a proactive role in educating patients on how liver function affects their health—especially if individuals are obese and might be at risk for liver disease.

As the first line of defense against the advancement of liver disease, HCPs can play a role in identifying most liver disease by adopting FibroScan to painlessly provide rapid, consistent results that enable them to make the most informed treatment decisions. Empowered with FibroScan scores and data, they can often rule out the need for an expensive and often painful liver needle biopsy or other invasive, expensive testing.

When liver stiffness and fat measurements are evaluated as part of the overall patient presentation, the HCP can make an immediate determination if referral to a liver specialist is warranted. This ability to risk stratify and monitor the patients’ liver health can reduce unnecessary and costly specialist referrals and inform earlier intervention, thus potentially impacting outcomes.

The liver stiffness and fat measurements from a FibroScan examination can serve to improve patient and HCP satisfaction. The ability to deliver immediate and actionable information to inform the patient care plan not only reduces the burden of multiple visits and specialist referrals, but also may increase engagement in lifestyle modification programs with the intent to ultimately reverse this life-threatening disease and related comorbidities.

Echosens has a growing, strong presence in HCP offices that provide primary care services. This has now expanded to include primary care provided in U.S. Federally Qualified Health Centers where HCPs work with specialists to serve the nation’s most vulnerable populations. Additionally, Echosens recognizes the opportunity to support the employer community: a full one-third (33 percent) of U.S. employers with 5,000 or more employees now offer general medical worksite clinics, with a key focus on primary and preventive care for employees and their families.

Supporting market partnerships and collaboration
Echosens supports the initiatives undertaken by patient advocacy organizations, such as the American Liver Foundation, and helps to increase public awareness of the importance of early detection and treatment of liver diseases. Our technology is gaining prominence among the most highly respected hospitals and institutions.

The NASH Network (NASHNET), a global Centers of Excellence Network represented by leading healthcare systems in collaboration with The Kinetix Group, is utilizing FibroScan in a pilot study to appropriately identify patients with progressive NAFLD. With a goal to create an optimal care delivery model in hospital systems, NASHNET will utilize FibroScan and associated screening tests in primary care, endocrinology and bariatric clinics.

NASHNET will collect and analyze data on 6,500 patients over a one-year period. This real-world evidence study is designed to identify cost-effective patient flows to screen, diagnose and manage patients with NAFLD and NASH. To accomplish this goal, the NASHNET steering committee is recommending that FibroScan devices be placed within their primary care and/or diabetic clinics.

The study will evaluate care models that utilize FibroScan in conjunction with routine lab tests, lipidomic and metabolic profiles, magnetic resonance elastography (MRE), exploratory biomarkers and morphometric analysis. The objective is to improve identification of patients with progressive NAFLD and reserve more costly assessments to those patients at greater risk for mortality and morbidity associated with the disease.

United States and worldwide expansion
Echosens attributes one-half of its current sales volume to the U.S. market and expects to increase that market share substantially in the near and short term. International initiatives are also underway, with strong receptivity for expanded adoption in Western Europe, Asia, China, Australia, Latin America and West Africa.

Given market need and readiness to tackle the frightening epidemic of liver disease, the Echosens technology platform is answering some of the world’s most pressing healthcare challenges.

About the authors: Dominique Legros, Group CEO, Echosens: A global healthcare business and technology expert based at the Echosens corporate headquarters and offices in Paris, France, Legros has international experience in both small companies and large global corporations, including Johnson & Johnson, Dentsply and Dentsply Sirona. With cultural sensitivity and significant expertise in successfully developing, transforming and leading enterprises worldwide, Legros is further expanding the impressive global footprint of Echosens to bring the benefits of its full range of products and services to an even greater number of physicians throughout the world and support their assessment and management of patients with chronic liver disease.

Jon Gingrich, CEO, Echosens North America: With more than 20 years of global medical device and health care sales, marketing and general management experience at AxoGen, Inc., Hologic, Inc., Boston Scientific Corporation and Unilever, N.V, Gingrich now leads the development and execution of the Echosens U.S. strategy for expanding the utilization of FibroScan technology in the assessment of chronic liver disease. As a member of the broader global executive leadership team, he works to implement the Company’s transformation plan and shape the future of Echosens.

View the article on HealthCare Business News here