TIDMRENX
Renalytix PLC
06 June 2022
Renalytix plc
("Renalytix" or the "Company")
Renalytix held Two Data Presentations on KidneyIntelX at
American Diabetes Association 82(nd) Scientific Sessions(R)
Real-world clinical utility in 1,112 patients tested with
KidneyIntelX
KidneyIntelX stratification for cardiovascular risk in 1,278
diabetic kidney disease patients
NEW YORK, NY and SALT LAKE CITY, UT June 6, 2022 - Renalytix
(NASDAQ: RNLX) (LSE: RENX) participated at the American Diabetes
Association (ADA) 82(nd) Scientific Sessions(R) meeting in New
Orleans from June 3-7, 2022. There were two data presentations
focused on the value of KidneyIntelX in care for adult patients
with type 2 diabetes (T2D) and early-stage chronic kidney disease
(CKD), including a late-breaking ePoster and an oral
presentation.
The ePoster, "Clinical Utility of KidneyIntelX on Patients with
Early-Stage Diabetic Kidney Disease-A Real-World Evidence Study"
was the first time Mount Sinai Health System presented data from
its real-world evidence clinical utility study with Renalytix in
1,112 patients tested with KidneyIntelX. The poster was presented
to in-person and virtual conference attendees on June 5, at 12:00
p.m. CT, with commentary on behalf of the study investigators by
Joji Tokita, M.D., Clinical Director, Division of Nephrology and
Associate Professor of Medicine at the Icahn School of Medicine at
Mount Sinai. Michael J. Donovan, Ph.D., M.D., Chief Medical Officer
of Renalytix, was also on-site for commentary.
A second oral presentation, "KidneyIntelX Association with
Clinical Outcomes in Diabetic Kidney Disease" was held on June 3,
at 4:45 p.m. CT by Steven G. Coca, D.O., M.S., Icahn School of
Medicine at Mount Sinai, and Co-Founder of Renalytix.
"We've seen the ADA's dedication to improving kidney health in
people with T2D firsthand as part of our ongoing collaboration to
develop a care pathway to advance screening, diagnosis and
early-stage treatment for the 40% of these patients who will
develop CKD," said Tom McLain, President, Renalytix. "Chronic
kidney disease can lead to significant complications for diabetes
patients including cardiovascular disease and heart failure, and
when left untreated can lead to dialysis and kidney transplant. Our
mission is to give healthcare professionals new tools to understand
an individual's risk for rapid progression of CKD, allowing them to
appropriately prescribe therapeutics and to utilize specialist
consultation when necessary. We look forward to joining other
industry leaders at this year's Scientific Sessions in showcasing
our research efforts."
The ePoster and oral presentation abstracts are available at the
2022 ADA Scientific Sessions Online Planner .
KidneyIntelX is based on technology developed by Mount Sinai
faculty and licensed to Renalytix. Mount Sinai and Mount Sinai
faculty, including Dr. Coca, have a financial interest in
Renalytix. Mount Sinai also has representation on the Renalytix
Board of Directors.
About Kidney Disease
Kidney disease is a public health epidemic affecting over 850
million people globally.(1) The Centers for Disease Control and
Prevention estimates that 15% of U.S. adults, or over 37 million
people(2) , have chronic kidney disease (CKD). Nearly 95% of people
with CKD are in early stages 1-3(3) . Despite its magnitude,
early-stage (1-3) CKD is underdiagnosed and undertreated, largely
because it's asymptomatic at this time in the disease. As many as 9
in 10 adults with CKD, and 2 in 5 adults with severe CKD do not
know they have the condition.(2)
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(TM) for kidney health. The
leadership team, with a combined 200+ years of healthcare and
in-vitro diagnostic experience, has designed KidneyIntelX to enable
risk assessment for rapid progressive decline in kidney function in
adult patients with T2D with early CKD stages 1-3 through its
KidneyIntelX(TM) laboratory-developed test. 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 KidneyIntelX(TM)
KidneyIntelX(TM) is a laboratory-developed test demonstrated to
be a highly reliable, bioprognostic(TM) methodology, that yields a
simple-to-understand, custom risk score, predicting which adult
patients with T2D and early CKD (stages 1-3) are at low,
intermediate or high risk for rapid progressive decline in kidney
function. By combining information from KidneyIntelX with newer
cardio- and reno-protective therapies, doctors will have more
information in determining which patients are at higher versus
lower risk for rapid disease progression and may be able to more
appropriately target resources and guideline-recommended treatments
to advance kidney health. KidneyIntelX is supported by a growing
body of clinical, utility and health economic studies (including a
validation study of two large cohorts) and has a demonstrated a 72%
improvement in predicting those patients who are at high risk for
rapid progressive decline in kidney function versus the current
standard of care (eGFR and UACR). KidneyIntelX has also received
Breakthrough Device Designation from the U.S. Food and Drug
Administration and has submitted for De Novo marketing
authorization. To learn more about KidneyIntelX and review the
evidence, visit www.kidneyintelx.com .
About the Mount Sinai Health System
The Mount Sinai Health System is New York City's largest
academic medical system, encompassing eight hospitals, a leading
medical school, and a vast network of ambulatory practices
throughout the greater New York region. Mount Sinai is a national
and international source of unrivaled education, translational
research and discovery, and collaborative clinical leadership
ensuring that we deliver the highest quality care-from prevention
to treatment of the most serious and complex human diseases. The
Health System includes more than 7,200 physicians and features a
robust and continually expanding network of multispecialty
services, including more than 400 ambulatory practice locations
throughout the five boroughs of New York City, Westchester, and
Long Island. The Mount Sinai Hospital is ranked No. 14 on U.S. News
& World Report's "Honor Roll" of the Top 20 Best Hospitals in
the country and the Icahn School of Medicine as one of the Top 20
Best Medical Schools in the country. Mount Sinai Health System
hospitals are consistently ranked regionally by specialty and our
physicians in the top 1% of all physicians nationally by U.S. News
& World Report.
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/kidneydisease/publications-resources/ckd-national-facts.html
(3) https://www.cdc.gov/kidneydisease/basics.html
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
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 Applegarth / Mob: 07980 541 893 / 07584 391 303
Alice Woodings / 07407 804 654
CapComm Partners
Peter DeNardo Tel: 415-389-6400 or investors@renalytix.com
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 benefits, including
economic savings, of KidneyIntelX, 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 21, 2021,
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
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