REG - Renalytix PLC - kidneyintelX.dkd data presented at ERA Congress

RenalytixAnnouncement

Tue 07:00

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RNS Number : 0765N  Renalytix PLC  17 June 2025

Renalytix plc

("Renalytix" or the "Company")

 

kidneyintelX.dkd data presented at ERA Congress

 

                kidneyintelX.dkd shown to enhance risk
assessment across all KDIGO categories

 

Use of SGLT2i reduces kidneyintelX.dkd risk levels on repeat testing

and is significantly associated with improved outcomes

 

LONDON and NEW YORK, 17 June 2025 - Renalytix plc (LSE: RENX) (OTCQB: RNLXY),
a precision medicine company with kidneyintelX.dkd, the only FDA-approved and
Medicare reimbursed prognostic test to support early-stage risk assessment in
chronic kidney disease, announces that new pivotal data demonstrating how
kidneyintelX.dkd enhances risk assessment over standard clinical measures
alone thereby enabling more efficient treatment allocation, was presented at
the prestigious European Renal Association Congress 2025 held in Vienna on 4-7
June.

 

The presentation titled "Evaluating KDIGO and KidneyintelX.dkd for Risk
Stratification in Diabetic Kidney Disease: Insights from CANVAS and CREDENCE"
was selected as one of the highest scoring abstracts for presentation.

 

The analysis included 2,954 subjects from the CANVAS and CREDENCE clinical
trials who met the kidneyintelX.dkd intended use criteria and were randomized
to treatment with SGLT2i or Placebo and followed for up to five years. The
kidneyintelX.dkd risk level was assessed at baseline and at the one-year
timepoint post randomization. Some of the key findings reported include:

 

-      The kidneyintelX.dkd test reclassified 40% of patients to a
different risk from baseline KDIGO risk levels category (e.g. from moderate to
high/low, low to moderate, or high to moderate/low)

-      Over the follow-up period, patients in the kidneyintelX.dkd
high-risk level at baseline displayed a >20 times observed risk (after
adjustment) compared to those classified as lowest risk by KDIGO

-      Treatment with SGLT2i reduced the kidneyintelX.dkd levels
significantly after one year compared to those not treated, with almost a 20%
between group difference in the changes observed

-      Patients who remained at high risk after one year had >4 times
higher risk of events than those who were re-classified to moderate risk

 

Commenting on the newly presented data, Fergus Fleming, Chief Technology
Officer, said: "The kidneyintelX.dkd data highlights the importance of
implementation of risk assessment and adoption of novel therapies such as
SGLT2 inhibitors in early-stage chronic kidney disease as reflected in the
2024 KDIGO guidelines. The data shows that by targeting care to patients at
highest risk of progression, a significant reduction in risk can be achieved
in the short-term leading to improved outcomes for patients in the long-term.
We believe there is strong clinical support to accelerate the implementation
of guideline directed care to prevent unnecessary patient suffering and
healthcare cost, and kidneyintelX.dkd is ideally placed to enable this."

 

The data analysis and presentation were co-authored by Renalytix and the
University Medical Center Groningen as part of the PRIME-CKD consortium
(https://www.prime-ckd.com/ (https://www.prime-ckd.com/) ). Additional
insights from the analysis will be presented at the American Diabetes
Association Scientific Sessions on 19-23 June highlighting how
kidneyintelX.dkd should be considered for enriching clinical trials and
assessing treatment response:

 

Abstract 420-P, Baseline Risk and Longitudinal Changes in kidneyintelX.dkd
Scores and Their Association with Kidney Outcomes in the CANVAS and CREDENCE
Trials, H.L. Heerspink et al

 

https://eppro02.ativ.me/src/EventPilot/php/express/web/planner.php?id=ADA25
(https://eppro02.ativ.me/src/EventPilot/php/express/web/planner.php?id=ADA25)

 

The complete analysis is being prepared for peer-reviewed publication later
this year.

 

For further information, please contact:

 

 Renalytix plc                                         www.renalytix.com (http://www.renalytix.com)
 James McCullough, CEO                                 Via Walbrook PR

 Stifel (Nominated Adviser and Joint Broker)           Tel: 020 7710 7600
 Fred Walsh / Nick Harland / Brough Ransom / Ben Good

 Oberon Capital (Joint Broker)                         Tel: 020 3179 5300
 Mike Seabrook / Nick Lovering

 Walbrook PR Limited                                   Tel: 020 7933 8780 or renalytix@walbrookpr.com
 Paul McManus / Alice Woodings                         Mob: 07980 541 893 / 07407 804 654

 

About Renalytix (www.renalytix.com (http://www.renalytix.com) )

Renalytix (LSE: RENX) (OTCQB: RNLXY) is an artificial intelligence-enabled in
vitro diagnostics company, focused on optimizing clinical management of kidney
disease to drive improved patient outcomes. Renalytix has received FDA
approval and Medicare reimbursement for kidneyintelX.dkd which is now offered
commercially in the United States.

 

Unrecognized and uncontrolled kidney disease remains one of the largest
barriers to controlling cost and suffering in the United States and the United
Kingdom's medical system, affecting over 14 million and 8 million people,
respectively. After five years of development and clinical validation,
kidneyintelX.dkd is the only FDA-approved and Medicare reimbursed prognostic
tool capable of understanding a patient's risk with kidney disease early where
treatment has maximal effect. kidneyintelX.dkd is now being deployed across
large physician group practices and health systems in select regions of the
United States.

 

The over 15,000 patients that have been tested by kidneyintelX.dkd have
produced a substantial body of real-world performance data. In patient
populations where kidneyintelX.dkd has been deployed, a demonstrated and
significant increase in diagnosis, prognosis, and treatment rates have been
recorded. kidneyintelX.dkd now has full reimbursement established by Medicare,
the largest insurance payer in the United States, at $950 per reportable
result. kidneyintelX.dkd is also recommended for use in the international
chronic kidney disease clinical guidelines (KDIGO).

 

KidneyIntelX is based on technology developed by Mount Sinai faculty and
licensed to Renalytix AI, Inc. Mount Sinai faculty members are co-founders and
equity owners in the Company. In addition, the Icahn School of Medicine at
Mount Sinai has equity ownership in Renalytix.

 

About European Renal Association (https://www.era-online.org/
(https://www.era-online.org/) )

With more than 28,000 members, the ERA (European Renal Association) is one of
the biggest nephrology associations worldwide and one of the most important
and prestigious European medical associations. It supports basic and clinical
research in the fields of clinical nephrology, dialysis, renal transplantation
and related subjects, and it is dedicated to advancing kidney health through
science, education, and networking.

 

Founded in 1963, ERA serves as a leading platform for scientific exchange,
professional development, and advocacy in the field of nephrology across
Europe and beyond. ERA organises annual congresses and supports fellowships,
and CME courses. ERA publishes two official leading nephrology journals in
Europe: Nephrology Dialysis Transplantation and Clinical Kidney Journal (open
access).

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