REG - Renalytix PLC - Late Breaking KidneyIntelX data show care impact

RenalytixAnnouncement

16/04/2025 07:00

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RNS Number : 1860F  Renalytix PLC  16 April 2025

Renalytix plc

("Renalytix" or the "Company")

 

Late Breaking KidneyIntelX data shows care impact

 

Data released at National Kidney Foundation Spring Clinical Meeting

 

LONDON and NEW YORK, 16 April 2025 - Renalytix plc (LSE: RENX) (OTCQB: RNLXY),
a precision medicine company with lead testing service kidneyintelX.dkd, the
only FDA-approved and Medicare reimbursed prognostic test to support
early-stage risk assessment in chronic kidney disease, notes the publication
of an abstract entitled: "Impact of KidneyIntelX on Targeted Use of SGLT2i".

 

The Late Breaking study describes how researchers assessed the increase in
prescription rates of sodium-glucose cotransporter 2 inhibitors (SGLT2i) in
response to KidneyIntelX testing, and for the first time, compared this
increase to a control population who did not receive the KidneyIntelX test but
were treated in the same health system over the same time period and were
eligible  for testing.

 

James McCullough, CEO of Renalytix, commented: "This new data continues to
demonstrate the powerful utility of KidneyIntelX to drive changes in care for
patients who need it most. It is notable that almost 70% of patients in this
study are treated at primary care and demonstrates that in the absence of
clear and early risk assessment, the opportunity to change the course of
disease can be lost resulting in catastrophic outcomes for patients."

 

The authors report that risk assessment for DKD progression with KidneyIntelX
not only resulted in increased use of SGLT2i but importantly, that increase
was targeted to those patients at moderate or high-risk of progression.
Conversely, new use of SGLT2i in the control group was not optimised for
kidney health with the lowest increase observed in patients subsequently
identified as high risk.

 

The presented data also highlights how patients identified as low risk by
KidneyIntelX do not appear to benefit from SGLT2i treatment for kidney health
protection while patients in moderate and high-risk groups benefit most from
early and targeted intervention.

 

The lead author is Joji Tokita, MD, from the Icahn School of Medicine Mount
Sinai, New York, and was presented at the National Kidney Foundation Spring
Clinical Meetings in Boston, MA on 10-13 April 2025. The full abstract and
data can be viewed here:

 

https://cme.kidney.org/spa/app/resource/r649-2025-spring-clinical-meetings/event/home/posters/abstracts?abstractId=7683
(https://cme.kidney.org/spa/app/resource/r649-2025-spring-clinical-meetings/event/home/posters/abstracts?abstractId=7683)

 

This announcement contains inside information for the purposes of Article 7 of
Regulation (EU) 596/2014, as it forms part of domestic law by virtue of the
European Union (Withdrawal) Act 2018.

 

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
 Nicholas Moore / 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.

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