TIDMRENX
RNS Number : 6348L
Renalytix PLC
14 September 2021
This announcement contains inside information
Renalytix plc
("Renalytix" or the "Company")
Mount Sinai Initiates System-wide Scale-Up of Renalytix
KidneyIntelX(TM) Enabled Health Care Model
Targeted testing run rate of 300 diabetic kidney disease
patients per week in calendar Q4 2021
NEW YORK and SALT LAKE CITY, September 14, 2021 - Renalytix plc
(NASDAQ: RNLX) (LSE: RENX) and the Mount Sinai Health System today
announced scaled-up implementation of the KidneyIntelX early-stage
risk assessment testing and care management program across primary
care and specialty clinician networks under a real-world evidence
development program for patients with diabetic kidney disease
(DKD). KidneyIntelX enables a shift in focus from care coordination
efforts focused on Mount Sinai's late-stage kidney disease patients
to a focus on patients with early stages of the disease where
prognosis and treatment with population health care navigation
assistance can improve patient care and outcomes and generate cost
savings. Before the end of 2021, Mount Sinai expects to provide
KidneyIntelX testing and downstream care management at a rate of
300 patients per week with approximately 6,000 eligible patients
tested by calendar Q2 2022 under this development program.
In an initial rollout across seven primary care practices in
Manhattan, New York City, the KidneyIntelX program has demonstrated
value for clinical care delivery by identifying patients with DKD
at low, intermediate, and high risk of declining kidney function or
kidney failure early in the disease lifecycle when treatment has
the potential for maximum effect. KidneyIntelX access is now
expected to grow to over 300 treating physicians in calendar Q4
2021. The number of eligible patients who have scheduled physician
interaction with active electronic health record access to
KidneyIntelX is expected to grow up to sixfold in the same
period.
"Our KidneyIntelX(TM) enabled diabetic kidney disease program
allows us to provide a high standard of care in early-stage kidney
disease patients where we have the best chance to help patients
avoid significant kidney damage", said Robert Fields, MD, MHA,
Executive Vice President and Chief Population Health Officer at
Mount Sinai Health System. "Ongoing analysis and sharing of doctor
and patient user experience combined with population level data
insights is helping to drive systemwide access to early-stage
risk-assessment and treatment."
"Systematically identifying high-risk patients with DKD under
primary care at the earliest stages of their disease is essential
for improving outcomes, quality of life, and reducing health care
cost in the population with kidney disease", said David C. Thomas,
MD, Professor of Medicine, Medical Education and Rehabilitation and
Human Performance and Interim System Chair, Department of Medicine,
Icahn School of Medicine at Mount Sinai. "We now have the tools,
including care navigation, and pharmacy and dietician support, in
place to do more than manage the transition to dialysis or
transplant. We believe this program will enable advanced support
for our primary care teams to help improve the long-term outlook
and quality of life for our patients with diabetic kidney
disease."
In 2021, Mount Sinai's KidneyIntelX enabled care program has
achieved significant milestones, including successful integration
into the clinical workflow across the Health System's network of
primary care and specialty physician practices. Early results of
the real-world evidence program are aligned with published utility
study data. These results indicate that appropriate pharmacy
management and specialist referrals are more likely when
KidneyIntelX testing is integrated into the care plan. These
actions are important for slowing the progression of DKD. Under
Mount Sinai's population health guided care model, primary care
physicians can receive direct test ordering, education and advanced
pharmacy, dietary and specialist support information for their DKD
patients.
KidneyIntelX includes technology that was initially developed by
Mount Sinai faculty. This technology has been licensed by Mount
Sinai to Renalytix. Mount Sinai and a small number of Mount Sinai
faculty inventors have a financial interest in Renalytix. Mount
Sinai also has representation on the Renalytix Board of
Directors.
The person responsible for this announcement is James
McCullough, CEO
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 Cawthorne Mob: 07980 541 893 / 07584 391 303
About KidneyIntelX
KidneyIntelX, is a first-of-kind, solution that enables
early-stage diabetic kidney disease progression risk assessment by
combining diverse data inputs, including validated blood-based
biomarkers, inherited genetics, and personalized patient data from
electronic health record, or EHR, systems, and employs a
proprietary algorithm 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 the global founder and
leader in the new field of bioprognosis(TM) for kidney health. The
company has engineered a new solution that successfully enables
early-stage chronic kidney disease, progression risk assessment.
The Company's lead product is KidneyIntelX, has been granted
Breakthrough Designation by the U.S. Food and Drug Administration
and is 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 .
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. We advance medicine and
health through unrivaled education and translational research and
discovery to deliver care that is the safest, highest - quality,
most accessible and equitable , and the best value of any health
system in the nation. The Health System includes approximately
7,300 primary and specialty care physicians; 13 free-standing
joint-venture centers; more than 410 ambulatory practices
throughout the five boroughs of New York City, Westchester, and
Long Island; and more than 30 affiliated community health centers.
The Mount Sinai Hospital is ranked in U.S. News & World
Report's "Honor Roll" of the top 20 U.S. hospitals and among the
top in the nation by specialty: No. 1 in Geriatrics and top 20 in
Cardiology/Heart Surgery, Diabetes/Endocrinology,
Gastroenterology/GI Surgery, Neurology/Neurosurgery, Orthopedics,
Pulmonology/Lung Surgery, Urology, and Rehabilitation. Mount Sinai
Kravis Children's Hospital is ranked in U.S. News & World
Report's "Best Children's Hospitals" among the country's best in
four out of 10 pediatric specialties. New York Eye and Ear
Infirmary of Mount Sinai is ranked among the Top 20 nationally for
ophthalmology. The Icahn School of Medicine at Mount Sinai is one
of three medical schools that have earned distinction by multiple
indicators: ranked in the top 20 by U.S. News & World Report's
"Best Medical Schools," aligned with a U.S. News & World Report
"Honor Roll" Hospital, and No. 14 in the nation for National
Institutes of Health funding. Newsweek's "The World's Best Smart
Hospitals" ranks The Mount Sinai Hospital as No. 1 in New York and
top five globally, and Mount Sinai Morningside as top 20 globally,
and "The World's Best Specialized Hospitals" ranks Mount Sinai
Heart as No. 1 in New York and No. 5 globally and the Division of
Gastroenterology as No. 5 globally. For more information, visit
https://www.mountsinai.org or find Mount Sinai on Facebook ,
Twitter
and YouTube .
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 commercial prospects of
KidneyIntelX, including whether KidneyIntelX will be successfully
adopted by physicians and distributed and marketed, the rate of
testing with KidneyIntelX in health care systems, expectations and
timing of announcement of real-world testing evidence, the
potential for KidneyIntelX to be approved for additional
indications, 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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