THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION
AS DEFINED IN ARTICLE 7 OF MAR. THE PERSON RESPONSIBLE FOR
ARRANGING THE RELEASE OF THIS ANNOUNCEMENT ON BEHALF OF RENALYTIX
IS JAMES MCCULLOUGH, CEO.
Renalytix
plc
("Renalytix" or the "Company")
KidneyIntelX™ included in
Final KDIGO 2024 Clinical Guideline for Chronic Kidney Disease
(CKD)
Guidelines highlight the importance of risk
prediction and personalized treatment to reduce risk
LONDON and SALT LAKE CITY, March 14, 2024 - Renalytix
plc (NASDAQ: RNLX) (LSE: RENX) (Renalytix) announces that the
KidneyIntelX In-Vitro
Diagnostic test has been included in the final KDIGO (Kidney
Disease Improving Global Outcomes)
2024 Clinical Practice Guideline for the Evaluation and
Management of Chronic Kidney Disease (CKD), published on March 13,
2024. In the release of the new guideline, timed to coincide
with World Kidney Day on March 14, the KDIGO committee highlighted
the role of risk prediction in guiding care for patients. In
this context, KidneyIntelX is recommended for use as an externally
validated tool for predicting disease progression in people with
CKD stages G1-G3.
The Guideline Work Group recognized that the
progression of CKD can occur at all stages, and that in earlier
stages of disease (G1-G3), understanding the risk of 40% decline in
kidney function over a short term 5 years, as per the indicated use
of KidneyIntelX, is important for guiding early intervention,
particularly in people at intermediate or high risk for
progression. Renalytix received FDA de-novo marketing authorization
for kidneyintelX.dkd in June 2023 for use in assessment
of the risk of progressive decline in kidney function in patients
with CKD stages G1-G3 and Type 2 Diabetes.
Subsequent to the release of the draft content of
this updated guideline in July 2023, further evidence has been
published from clinical utility and outcomes studies with a current
enrollment of more than 9,000 patients with Type 2 Diabetes and CKD
G1-G3. In January 2024, published outcomes data from an
analysis of more than 2,500 patients with one year of follow-up
demonstrated that providing clinicians access to KidneyIntelX risk
assessment to inform care was associated with clinical actions that
resulted in sustained reduction in eGFR decline, improved diabetes
management and improved cardiovascular health.
In the KDIGO
announcement of the publication of the 2024 CKD guideline, Adeera
Levin MD, one of the Guideline Committee Co-Chairs said,
"Recent advancements in GFR
evaluation, risk prediction, and the arrival of novel treatments
are poised to enhance CKD prognosis and management. We also hope
the guideline's emphasis on multidisciplinary teamwork, patient
engagement, and a holistic, evidence-based approach to care will
help catalyze positive change, resulting in more coordinated CKD
care management worldwide. By integrating the latest evidence and
expert consensus, we aim to empower healthcare professionals, and
patients with actionable recommendations to optimize patient
outcomes and enhance quality of life."
Commenting on the
guideline release Michael J.
Donovan, PhD, MD, Chief Medical Officer at Renalytix
stated,
"Patients with type 2 diabetes
and CKD are benefitting from the evidence gathered from a number of
recent clinical trials and access to accurate risk assessment to
inform care in a significant and growing healthcare challenge in
the United States and globally. Renalytix welcomes these new
updates from KDIGO which provide for clear and timely treatment
strategies for health care professionals and we look forward to
continuing to release evidence to highlight the role that
KidneyIntelX is playing achieving the goal of optimizing patients'
outcomes and enhancing quality of life."
For
further information, please contact:
Renalytix
plc
|
www.renalytix.com
|
James McCullough, CEO
|
Via Walbrook PR
|
|
|
Stifel (Nominated
Adviser, Joint Broker)
|
Tel: 020 7710 7600
|
Alex Price / Nicholas Moore / Nick Harland / Samira
Essebiyea
|
|
|
|
Investec Bank plc
(Joint Broker)
|
Tel: 020 7597 4000
|
Gary Clarence / Shalin Bhamra
|
|
|
|
Walbrook PR
Limited
|
Tel: 020 7933 8780 or renalytix@walbrookpr.com
|
Paul McManus / Alice Woodings
|
Mob: 07980 541 893 / 07407
804 654
|
|
|
CapComm
Partners
|
|
Peter DeNardo
|
Tel: 415-389-6400 or investors@renalytix.com
|
|
| |
About Chronic Kidney
Disease
Kidney disease is now recognized as a public health
epidemic affecting over 850 million people globally. The Centers
for Disease Control and Prevention (CDC) estimates that 15% of US
adults, more than 38 million people, currently have chronic kidney
disease (CKD). Diabetes is the leading cause of kidney failure,
accounting for 44% of new cases. Further, the CDC reports that 9
out of 10 adults with CKD do not know they have it and one out of
two people with very low kidney function who are not on dialysis do
not know they have CKD.1 Kidney disease is referred
to as a "silent killer" because it often has no symptoms and can go
undetected until a very advanced stage. Each year, kidney disease
kills more people than breast and prostate cancer. Every day, 13
patients in the United States die while waiting for a kidney
transplant.
About Type 2
Diabetes
More than 37 million Americans have diabetes (about 1
in 10), and approximately 90-95% of them have type 2 diabetes. Type
2 diabetes most often develops in people over age 45, but more and
more children, teens, and young adults are also developing the
disease2. Type 2 diabetes symptoms often develop over
several years and approximately 23% of adults with type 2 diabetes
are undiagnosed3. Type 2 diabetes affects many major
organs, including the heart, blood vessels, nerves, eyes and
kidneys. Diabetic kidney disease develops in 30-50% of type 2
diabetes patients4.
About
Renalytix
Renalytix (NASDAQ: RNLX) (LSE: RENX) is an in-vitro
diagnostics and laboratory services company that is the global
founder and leader in the new field of bioprognosis™ for kidney
health. The leadership team, with a combined 200+ years of
healthcare and in-vitro diagnostic experience, has designed its
KidneyIntelX laboratory developed test to enable risk assessment
for rapid progressive decline in kidney function in adult patients
with T2D and early CKD (stages 1-3). We believe that by
understanding how disease will progress, patients and providers can
take action early to improve outcomes and reduce overall health
system costs. For more information, visit www.renalytix.com.
About the Kidney
Disease: Improving Global Outcomes (KDIGO) 2024 Clinical Practice
Guideline for
the Evaluation and
Management of Chronic Kidney Disease (CKD)
The Kidney Disease: Improving Global Outcomes (KDIGO)
2024 Clinical Practice Guideline for the Evaluation and Management
of Chronic Kidney Disease (CKD) is an update to the KDIGO 2012
guideline on the topic. The aim is to assist clinicians caring for
people with CKD, both adults and children. People receiving
dialysis and kidney transplant recipients are not the focus of this
guideline. The scope includes chapters dedicated to the evaluation
of CKD, risk assessment in people with CKD, management to delay CKD
progression and manage its complications, medical management and
drug stewardship in CKD, and optimal models of CKD care. In
addition, this guideline includes a comprehensive introduction from
the guideline Co-Chairs, a patient foreword, a discussion of
special population considerations, a presentation of the relative
and absolute risks associated with specific outcomes from the CKD
Prognosis Consortium (CKDPC), and an extensive section dedicated to
research recommendations based on the current gaps in evidence. The
goal of the guideline is to generate a useful resource for
clinicians and patients by providing actionable recommendations
based on a rigorous formal evidence review, practice points that
serve to direct clinical care or activities for which a systematic
review was not conducted, and useful infographics. The guideline
targets a broad audience of healthcare providers involved in the
care of people with CKD as well as people with CKD themselves while
being mindful of implications for policy and payment. Development
of this guideline update followed an explicit process of evidence
review and appraisal. Treatment approaches and guideline
recommendations are based on systematic reviews of relevant
studies, and appraisal of the certainty of the evidence and the
strength of recommendations followed the "Grading of
Recommendations Assessment, Development, and Evaluation" (GRADE)
approach. Limitations of the evidence are discussed, with areas of
future research also presented
Sources
1 https://www.theisn.org/blog/2020/11/27/more-than-850-million-worldwide-have-some-form-of-kidney-disease-help-raise-awareness/
2 https://www.cdc.gov/diabetes/basics/type2.html
3 https://www.cdc.gov/diabetes/data/statistics-report/index.html
4 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5297507/
Forward Looking
Statements
Statements contained in this announcement regarding
matters that are not historical facts are "forward-looking
statements" within the meaning of the Private Securities Litigation
Reform Act of 1995, as amended. Examples of these forward-looking
statements include statements concerning: the ability of
KidneyIntelX to predict disease progression in people with CKD
stages G1-G3 and guide early intervention; the ability of
KidneyIntelX risk assessment to inform care resulting in sustained
reduction in eGFR decline, improved diabetes management and
improved cardiovascular health; and the ability of the KDIGO 2024
Clinical Guideline's emphasis on multidisciplinary teamwork,
patient engagement, and a holistic, evidence-based approach to care
to help catalyze positive change, resulting in more coordinated CKD
care management worldwide. Words such as "anticipates," "believes,"
"estimates," "expects," "intends," "plans," "seeks," and similar
expressions are intended to identify forward-looking statements. We
may not actually achieve the plans and objectives disclosed in the
forward-looking statements, and you should not place undue reliance
on our forward-looking statements. Any forward-looking statements
are based on management's current views and assumptions and involve
risks and uncertainties that could cause actual results,
performance, or events to differ materially from those expressed or
implied in such statements. These risks and uncertainties include,
among others: that KidneyIntelX and kidneyintelX.dkd are based on
novel artificial intelligence technologies that are rapidly
evolving and potential acceptance, utility and clinical practice
remains uncertain; we have only recently commercially launched
KidneyIntelX; and risks relating to the impact on our business of
the COVID-19 pandemic or similar public health crises. These and
other risks are described more fully in our filings with the
Securities and Exchange Commission (SEC), including our most recent
Quarterly Report on Form 10-Q and the "Risk Factors" section of our
Annual Report on Form 10-K filed with the SEC on September 28,
2023, and other filings we make with the SEC from time to time. All
information in this press release is as of the date of the release,
and we undertake no obligation to publicly update any
forward-looking statement, whether as a result of new information,
future events, or otherwise, except as required by law.