TIDMRENX
RNS Number : 6483A
Renalytix AI PLC
03 June 2021
Renalytix AI plc
("Renalytix" or the "Company")
Utility Study Indicates KidneyIntelX Risk Assessment can Address
Treatment Ambiguity in Primary Care
Clinicians affirm need for accurate early-stage diabetic kidney
disease risk assessment to improve patient outcomes and reduce
healthcare costs
NEW YORK, June 3, 2021 - Renalytix AI plc (LSE: RENX) (NASDAQ:
RNLX) today announced results from a new utility study. The study
confirmed the importance of risk assessment testing in addressing
treatment ambiguity in the early stages of diabetic kidney disease
(DKD) and improving patient engagement and adherence, two major
barriers to slowing or preventing DKD progression and preserving
kidney health. In clinical studies, KidneyIntelX has shown to
accurately predict progression of DKD, suggesting that KidneyIntelX
risk assessment could support primary care physicians in making
appropriate treatment decisions and slowing or preventing DKD
progression.
In this qualitative study involving 16 primary care physicians,
100% of clinician study participants confirmed that early-stage
kidney risk assessment, like that provided by KidneyIntelX, will
help to address suboptimal therapy, which can lead to rapid
progression, increased hospital admissions, emergency room visits,
potential kidney failure, need for dialysis, decreased quality of
life, and increased costs.
Dr. Joseph Vassalotti, Chief Medical Officer of the National
Kidney Foundation (NKF) and Clinical Professor at the Icahn School
of Medicine Mount Sinai Health System commented, "The NKF believes
primary care physicians have the power to change the outcome for
the vast majority of individuals with early-stage kidney disease
who are at risk for progressive kidney disease. Americans living
with kidney diseases universally express the preference for early
diagnosis. This study confirms the compelling data presented at
this year's NKF Spring Clinical Meeting that KidneyIntelX could be
widely adopted by primary care physicians (PCPs) and could alter
how at-risk populations with type-2 diabetes can receive early
education and therapeutic intervention to reduce DKD complications
and kidney failure.
"At NKF we are fueled with urgency to significantly improve the
long-term outcomes that restore full lives for people living with
kidney diseases. We encourage PCPs embrace the ability to manage
kidney disease risk early to protect their patient's kidney
health."
In the study, 94% of PCP participants found that kidney disease
was difficult to manage in their type 2 diabetes patients. Accurate
risk stratification is a critical unmet need and can lead to delays
in effective, early interventions.
The study was based on qualitative interviews with sixteen PCPs
treating DKD patients. Participating PCPs specialized in internal
medicine or family medicine and worked across the major settings of
care in the U.S., including private practices, academic medical
centers, and integrated delivery networks. Four main themes in DKD
were analyzed in the study: Screening Practices; Perceived
Knowledge Gaps; Treatment Variability; and the Importance of Risk
Stratification. The publication titled, " A Qualitative Study
Documenting Unmet Needs in the Management of Diabetic Kidney
Disease (DKD) in the Primary Care Setting ," was published in BMC
Public Health on May 17, 2021 .
For further information, please contact:
Renalytix AI plc www.renalytixai.com
James McCullough, CEO Via Walbrook PR
Stifel (Nominated Adviser, Joint Broker) Tel: 020 7710 7600
Alex Price / Nicholas Moore
Investec Bank plc (Joint Broker) Tel: 020 7597 4000
Gary Clarence / Daniel Adams
Walbrook PR Limited Tel: 020 7933 8780 or renalytix@walbrookpr.com
Paul McManus / Lianne Cawthorne Mob: 07980 541 893 / 07584
391 303
About 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, or 37
million people, currently have chronic kidney disease (CKD).
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 KidneyIntelX
KidneyIntelX, is a first-of-kind, bioprognostic(TM) platform
that employs a proprietary artificial intelligence-enabled
algorithm to combine diverse data inputs, including validated
blood-based biomarkers, inherited genetics, and personalized
patient data from electronic health record, or EHR, systems, to
generate a unique patient risk score. This patient risk score
enables prediction of progressive kidney function decline in
chronic kidney disease, or CKD, allowing physicians and healthcare
systems to optimize the allocation of treatments and clinical
resources to patients at highest risk.
About Renalytix
Renalytix (LSE: RENX) (NASDAQ: RNLX) is a developer of
artificial intelligence-enabled clinical in vitro diagnostic
solutions for kidney disease, one of the most common and costly
chronic medical conditions globally. The Company's lead product is
KidneyIntelX, which has been granted Breakthrough Designation by
the U.S. Food and Drug Administration and which is being designed
to help make significant improvements in kidney disease prognosis,
transplant management, clinical care, patient stratification for
drug clinical trials, and drug target discovery (visit
www.kidneyintelx.com ). For more information, visit
www.renalytix.com .
Sources
1
https://www.cdc.gov/kidneydisease/publications-resources/2019-national-facts.html
Forward Looking Statements
Statements contained in this press release 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 potential for KidneyIntelX to
receive regulatory approval from the FDA, the commercial prospects
of KidneyIntelX, if approved, including whether KidneyIntelX will
be successfully adopted by physicians and distributed and marketed,
our expectations regarding reimbursement decisions and the ability
of KidneyIntelX to curtail costs of chronic and end-stage kidney
disease, optimize care delivery and improve patient outcomes. 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 is 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 the "Risk Factors" section of our
annual report on Form 20-F filed with the SEC on October 28, 2020,
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.
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