Renalytix plc
(NASDAQ: RNLX) (LSE: RENX) today
announced its participation at the American Diabetes Association
(ADA) 82nd Scientific Sessions® meeting in New Orleans from June
3-7, 2022. There will be 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”
will be the first time Mount Sinai Health System is presenting data
from its real-world evidence clinical utility study with Renalytix
in 1,112 patients tested with KidneyIntelX. The poster will be
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, will be available on-site for
commentary.
A second oral presentation, “KidneyIntelX Association with
Clinical Outcomes in Diabetic Kidney Disease” will be 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.”
Renalytix will be exhibiting at booth #1803. The ePoster (Board
No. 14) and oral presentation (Board No. 19) abstracts are
available to conference attendees and public online through 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 DiseaseKidney 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 RenalytixRenalytix
(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 bioprognosisTM 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
with 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
KidneyIntelXTM KidneyIntelXTM is
a laboratory-developed test demonstrated to be a reliable,
bioprognosticTM methodology that yields a simple-to-understand,
custom risk score, enabling prediction of 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 SystemThe 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.html3
https://www.cdc.gov/kidneydisease/basics.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 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 law.
Media Contacts:United
States:Chloe BeaudoinRenalytix(207)
333-7947cbeaudoin@renalytix.com
Outside of the United States:Walbrook
PR LimitedPaul McManus / Lianne Applegarth / Alice
WoodingsTel: 020 7933 8780 or renalytix@walbrookpr.com Mob:
07980 541 893 / 07584 391 303 / 07407 804 654
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