Renalytix plc (NASDAQ: RNLX) (LSE: RENX) announces the publication
of new real-world evidence (RWE) in Primary Care and Community
Health demonstrating the Company’s KidneyIntelX bioprognostic™ test
resulted in changed clinical decision making for patients in the
early-stage of diabetic kidney disease (DKD) being cared for within
the Mount Sinai Health System’s Population Health Ambulatory
Pharmacy and Condition Management programs. The majority of
patients were being treated by their primary care physician.
Prediction of risk for kidney disease progression in early-stage
DKD is often not assessed at the primary care level, resulting in
more than 50,000 individuals per year with diabetes progressing to
kidney failure, dialysis or a kidney transplant. By integrating an
easily interpretable, accurate prognostic tool that assigns a risk
score for progressive decline in kidney function, KidneyIntelX
enables providers to act earlier to slow or stop the progression to
kidney failure.
“The data is greatly encouraging for millions of early stage 1-3
DKD patients where we lack patient-specific risk assessment tools
to adjust appropriate care. Utilizing KidneyIntelX to identify
which patients can most benefit from guideline-based therapies such
as SGLT2 inhibitors, more education on diabetes and CKD, and
referrals to specialists such as dieticians, diabetologists, and/or
nephrologists, is an opportunity to swing the pendulum from
suboptimal to optimal care,” said Robert Fields, MD, MHA, Executive
Vice President and Chief Population Health Officer for the Mount
Sinai Health System.
According to Michael J. Donovan, PhD, MD, Chief Medical Officer
at Renalytix, “The impacts of KidneyIntelX early risk assessment,
even at this interim 6 month time point, are very encouraging that
we can proactively move to control cost and outcomes in diabetes
and kidney disease. Enabling primary care physicians to recognize
risk and clinically manage patients with DKD can potentially
eliminate unnecessary events from uncontrolled disease progression,
including kidney failure and dialysis. We look forward to
continuing published data releases at the one-year mark.”
Key points from the prospective study:
- The study was conducted in
collaboration with the Mount Sinai Health System’s Population
Health Ambulatory Pharmacy and Condition Management programs and
included 1,686 patients seen by 75 providers at 20 clinical
sites.
- The RWE study demonstrated that
patients with early-stage DKD and a high risk KidneyIntelX score
received higher frequency of clinical management visits,
introduction to guideline-recommended medications, and specialist
referral for disease management compared to those who were
identified as low or intermediate risk patients.
- The risk breakdown of the RWE study
population was similar to the clinical validation cohort (high risk
12% vs. 17%, intermediate risk 40% vs. 37%, and low risk 48% vs
46%, respectively).
- Frequency of follow up
visits: 53% of all KidneyIntelX high risk patients had a
follow-up visit within 1-month of their KidneyIntelX test and 57%
had action taken (medication change or referral) within 3-months,
compared to 13% and 35%, respectively, for low risk patients.
- Medication
management: When evaluating new or modified prescriptions
for hypertension at six months, both ACEi and ARBs achieved a
greater than 20% change in patients with hypertension in the high
risk group vs. the low risk group. Medication management for use of
SGLT2 inhibitors was even more pronounced; 25% of patients in the
high risk group received new SGLT2i prescriptions vs. 7% in the low
risk group, a 4.5-fold increase. Thus, KidneyIntelX enabled
physicians to take guideline-recommended clinical actions in high
risk, early stage (stage 1-3b) diabetic kidney disease
patients.
- Specialist
referrals: New referrals by risk group were 6% for low
risk, 12% intermediate risk and 15% high risk.
The full study is available here.
KidneyIntelX is based on technology developed by Mount Sinai
faculty and licensed to Renalytix. The RWE study is being conducted
at the Mount Sinai Health System, New York, NY, and funded by
Renalytix. Mount Sinai and Mount Sinai faculty 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
people2, have chronic kidney disease (CKD). Nearly 95% of people
with CKD are in early stages 1-33. 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.3
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™ 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
and 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 KidneyIntelX™
KidneyIntelX™ is a laboratory developed test demonstrated to be
a reliable, bioprognostic™ 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 received
Breakthrough Device Designation from the U.S. Food and Drug
Administration and Renalytix 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
Mount Sinai Health System is one of the largest academic medical
systems in the New York metro area, with more than 43,000 employees
working across eight hospitals, over 400 outpatient practices,
nearly 300 labs, a school of nursing, and a leading school of
medicine and graduate education. Mount Sinai advances health for
all people, everywhere, by taking on the most complex health care
challenges of our time — discovering and applying new scientific
learning and knowledge; developing safer, more effective
treatments; educating the next generation of medical leaders and
innovators; and supporting local communities by delivering
high-quality care to all who need it.
Through the integration of its hospitals, labs, and schools,
Mount Sinai offers comprehensive health care solutions from birth
through geriatrics, leveraging innovative approaches such as
artificial intelligence and informatics while keeping patients’
medical and emotional needs at the center of all treatment. The
Health System includes approximately 7,300 primary and specialty
care physicians; 13 joint-venture outpatient surgery centers
throughout the five boroughs of New York City, Westchester, Long
Island, and Florida; and more than 30 affiliated community health
centers. We are consistently ranked by U.S. News & World
Report's Best Hospitals, receiving high "Honor Roll" status, and
are highly ranked: No. 1 in Geriatrics and top 20 in
Cardiology/Heart Surgery, Diabetes/Endocrinology,
Gastroenterology/GI Surgery, Neurology/Neurosurgery, Orthopedics,
Pulmonology/Lung Surgery, Rehabilitation, and Urology. New York Eye
and Ear Infirmary of Mount Sinai is ranked No. 12 in Ophthalmology.
U.S. News & World Report’s “Best Children’s Hospitals”
ranks Mount Sinai Kravis Children's Hospital among the country’s
best in several pediatric specialties. The Icahn School of Medicine
at Mount Sinai is one of three medical schools that have earned
distinction by multiple indicators: It is consistently 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 top 20 in the nation for
National Institutes of Health funding and top 5 in the nation for
numerous basic and clinical research areas. Newsweek’s “The
World’s Best Smart Hospitals” ranks The Mount Sinai Hospital as No.
1 in New York and in the top five globally, and Mount Sinai
Morningside in the top 20 globally. For more information,
visit https://www.mountsinai.org or find Mount Sinai
on Facebook, Twitter, and YouTube.
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 future impact of
KidneyIntelX on clinical decision-making and outcomes, the
potential for KidneyIntelX to receive regulatory approval from the
FDA, the commercial prospects of KidneyIntelX, if approved,
including whether and to what extent 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, address systemic inequalities and
improve patient outcomes. The results presented in this press
release are interim results; subsequent interim results and full
results may vary and may not be consistent with these interim
results. 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 31, 2022,
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:RenalytixKarla
Gonyekgonye@renalytix.com 617-590-5731media@renalytix.com
Outside of the United States:Walbrook
PR LimitedPaul McManus / Lianne Applegarth / Alice
Woodings
Tel: 020 7933 8780 or renalytix@walbrookpr.comMob: 07980
541 893 / 07584 391 303 / 07407 804 654
Renalytix (NASDAQ:RNLX)
Historical Stock Chart
From Mar 2024 to Apr 2024
Renalytix (NASDAQ:RNLX)
Historical Stock Chart
From Apr 2023 to Apr 2024