New ICD-10-CM Code by the World Health Organization Paves the Way for Improved NAFLD Diagnostics Including ENDRA Life Sciences’ TAEUS System
21 Febbraio 2024 - 2:00PM
Business Wire
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 1/50th 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.
Forward-Looking Statements
All statements in this press release that are not based on
historical fact are “forward-looking statements” within the meaning
of Section 27A of the Securities Act of 1933 and Section 21E of the
Securities Exchange Act of 1934. Forward-looking statements, which
are based on certain assumptions and describe our future plans,
strategies and expectations, can generally be identified by the use
of terms such as “approximate,” “anticipate,” “attempt,” “believe,”
“could,” “estimate,” “expect,” “forecast,” “future,” “goal,”
“hope,” “intend,” “may,” “plan,” “possible,” “potential,”
“project,” “seek,” “should,” “will,” “would,” or other comparable
terms (including the negative of any of the foregoing), although
some forward-looking statements are expressed differently. Examples
of forward-looking statements for ENDRA include, among others:
estimates of the timing of future events and anticipated results of
its development efforts, including the timing of submission for and
receipt of required regulatory approvals and product launches and
sales; statements relating to future financial position and
projected costs and revenue; expectations concerning ENDRA’s
business strategy; and statements regarding ENDRA’s ability to find
and maintain development partners. Forward-looking statements
involve inherent risks and uncertainties that could cause actual
results to differ materially from those in the forward-looking
statements as a result of various factors including, among others:
the ability to raise additional capital in order to continue as a
going concern; the ability to obtain regulatory approvals necessary
to sell ENDRA medical devices in certain markets in a timely
manner, or at all; the ability to develop a commercially feasible
technology and its dependence on third parties to design and
manufacture its products; ENDRA’s ability to maintain compliance
with Nasdaq listing standards; ENDRA’s dependence on its senior
management team; market acceptance of ENDRA’s technology and the
amount and nature of competition in its industry; ENDRA’s ability
to protect its intellectual property; and the other risks and
uncertainties described in the Risk Factors and Management’s
Discussion and Analysis of Financial Condition and Results of
Operations sections of the Company’s most recent Annual Report on
Form 10-K and in subsequent Quarterly Reports on Form 10-Q filed
with the SEC. You should not rely upon forward-looking statements
as predictions of future events. The forward-looking statements
made in this press release speak only as of the date of issuance,
and ENDRA assumes no obligation to update any such forward-looking
statements to reflect actual results or changes in expectations,
except as otherwise required by law.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240221976383/en/
Company: Irina Pestrikova Senior Director, Finance
investors@endrainc.com www.endrainc.com
Investor Relations: Yvonne Briggs LHA Investor Relations
(310) 691-7100 ybriggs@lhai.com
Grafico Azioni ENDRA Life Sciences (NASDAQ:NDRA)
Storico
Da Dic 2024 a Gen 2025
Grafico Azioni ENDRA Life Sciences (NASDAQ:NDRA)
Storico
Da Gen 2024 a Gen 2025
