New ICD-10-CM Code by the World Health Organization Paves the Way for Improved NAFLD Diagnostics Including ENDRA Life Sciences’ TAEUS System

Code Complements Important Advancements by the Pharmaceutical Industry and Revised Medical Association Guidelines

ENDRA Life Sciences Inc. (NASDAQ: NDRA), a pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS^®), welcomes the adoption of the ICD-10 K76.0 code for the diagnosis of Non-Alcoholic Fatty Liver Disease (NAFLD). This pivotal update supports recent important advancements in the field of liver disease to underscore the increasing recognition of NAFLD's impact on global health by insurers and healthcare providers alike. ENDRA’s TAEUS system has received a CE mark in the European Union and is the subject of a De Novo request that is pending before the U.S. Food and Drug Administration (FDA).

The International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM), is a global coding system used to indicate a diagnosis for reimbursement purposes. These codes are issued by the World Health Organization (WHO) and are used to show payers why a particular service was medically necessary. The inclusion of NAFLD under the ICD-10 K76.0 code facilitates standardized billing for its diagnosis. It is applicable across the U.S., Europe and other regions, and promotes consistency in medical documentation and insurance processes. The U.S. Centers for Medicare & Medicaid Services (CMS) also utilizes ICD-10 codes for claims payment adjudication and reimbursement of contracted providers.

ENDRA believes the issuance of the ICD-10 K76.0 code specifically for NAFLD measurement represents a significant opportunity for innovation in liver health diagnostics as healthcare providers now have a clearer pathway to integrate advanced diagnostic technologies. This encourages the adoption of state-of-the-art methods such as ENDRA's TAEUS liver fat measurement system or service, thereby improving patient access to essential healthcare services and emphasizing the importance of early detection and management of liver diseases.

"As we witness a rising prevalence of NAFLD globally, the inclusion of this condition in the ICD-10 coding framework marks a critical step toward better healthcare outcomes," said Jing Gao, M.D., FAIUM, Professor of Ultrasound at Rocky Vista University and Adjunct Professor of Research in Radiology at Weill Cornell Medicine. "This positive development is testament to the growing awareness of liver health and the intensifying need for effective diagnostic solutions. Along with tremendous clinical advancements with therapeutics targeting liver disease, it paves the way for enhanced patient care and a healthier future for individuals at risk of liver diseases."

The pharmaceutical industry continues to make important clinical and regulatory advancements in their commitment to addressing the large and growing unmet market opportunity of liver disease, including a drug candidate under review by the FDA that has the potential to become the first therapeutic approved for NASH.

Medical associations have also heightened their focus on screening for NAFLD, as evidenced by the following:

• In June 2023, the American Diabetes Association updated their Standards of Care in Diabetes [Section 4.11a] to state, “Adults with type 2 diabetes or pre-diabetes, particularly those with obesity or cardiometabolic risk factors/established cardiovascular disease should be screened/risk stratified for nonalcoholic fatty liver disease with clinically significant fibrosis (defined as moderate fibrosis to cirrhosis) using a calculated fibrosis-4 index (derived from age, ALT, AST, and platelets), even if they have normal liver enzymes.”
• Similarly, in March 2022 the American Association of Clinical Endocrinology updated their Clinical Practice Guidelines of Nonalcoholic Fatty Liver Disease in Primary Care and Endocrinology Clinical Settings to state, “Clinicians should consider persons with obesity and/or features of metabolic syndrome, those with prediabetes or T2D, and those with hepatic steatosis on any imaging study and/or persistently elevated plasma aminotransferase levels to be ‘high risk’ and screen for NAFLD and advanced fibrosis.”

“ENDRA is dedicated to advancing liver health diagnostics through innovation,” stated Francois Michelon, Chairman and Chief Executive Officer of ENDRA. “With a robust global patent estate supporting a portfolio of current and future clinical applications, along with a commitment to research and development, ENDRA is poised to lead the charge in combating NAFLD and improving liver health outcomes worldwide.

“The acknowledgment of NAFLD in the reimbursement landscape not only benefits patients by enhancing access to diagnostic services, but also signals a broader shift toward more proactive and preventive healthcare measures. It is a call to action for the medical community to prioritize liver health, and for the developers of diagnostic tools to support healthcare providers through innovative technologies,” he concluded.

About ENDRA Life Sciences Inc.

ENDRA Life Sciences is the pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS^®), a ground-breaking technology, which characterizes tissue like MRI, but at 1/50^th the cost and at the point of patient care. TAEUS^® is initially focused on the measurement of fat in the liver as a means to assess and monitor Steatotic Liver Disease (SLD) (formerly known as NAFLD-NASH), a chronic liver spectrum that affects over two billion people globally, and for which there are no practical diagnostic tools. Beyond the liver, ENDRA is exploring several other clinical applications of TAEUS^®, including visualization of tissue temperature during energy-based surgical procedures. For more information, please visit www.endrainc.com.

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