US Patent Office Allows Patent Claims for Intellectual Property Exclusively Licensed to Renalytix
06 Outubro 2023 - 8:00AM
Renalytix plc (NASDAQ: RNLX) (LSE: RENX), the first company to
commercialize an FDA authorized artificial intelligence (AI)
enabled blood test to assess risk of progressive kidney function
decline for individuals with type 2 diabetes and early-stage
chronic kidney disease, announces that the US Patent Office has
issued a new notice of allowance of claims surrounding the
biomarkers sTNFR1 and sTNFR2 used in the kidneyintelX.dkd
test. These claims were filed under US Patent Application No.
16/671.256 by the Joslin Diabetes Center and this patent is
exclusively licensed to Renalytix. KidneyintelX.dkd received
Food and Drug Administration de Novo marketing authorization on
June 29, 2023.
The newly allowed claims further strengthen the
core intellectual property underpinning the KidneyIntelX technology
by directly incorporating sTNFR1 and sTNFR2 into a set of
consolidated claims directed towards identifying risk of early
kidney function decline, thereby enabling therapeutic strategies
for those at increased risk of progressive decline.
The Company believes this development reflects
the Renalytix strategy of innovation in biomarker research,
development and translation in collaboration with the Joslin
Diabetes Center and other leading research partners globally. When
taken together with other key milestones, such as FDA De Novo
marketing authorization, broad insurance coverage and published
clinical utility and outcomes data, Renalytix believes this
increases its competitive advantage. The Company also believes this
creates further barriers to entry in the large addressable market
for optimizing clinical management of kidney disease to drive
improved patient outcomes. A similar strategy to protect
Renalytix’s intellectual property is being pursued in Europe, which
also presents a large opportunity for KidneyIntelX expansion.
For further information, please contact:
Renalytix plc |
www.renalytix.com |
James McCullough, CEO |
Via Walbrook PR |
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Stifel (Nominated Adviser, Joint Broker) |
Tel: 020 7710 7600 |
Alex Price / Nicholas Moore / Nick Harland / Samira Essebiyea |
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Investec Bank plc (Joint Broker) |
Tel: 020 7597 4000 |
Gary Clarence / Shalin Bhamra |
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Walbrook PR Limited |
Tel: 020 7933 8780 or
renalytix@walbrookpr.com |
Paul McManus / Lianne Applegarth |
Mob: 07980 541 893 / 07584 391 303 |
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CapComm Partners |
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Peter DeNardo |
Tel: 415-389-6400 or investors@renalytix.com |
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About Chronic Kidney
DiseaseKidney disease is now recognized as a public health
epidemic affecting over 850 million people globally. The Centers
for Disease Control and Prevention (CDC) estimates that 15% of US
adults, more than 38 million people, currently have chronic kidney
disease (CKD). Diabetes is the leading cause of kidney failure,
accounting for 44% of new cases. Further, the CDC reports that 9
out of 10 adults with CKD do not know they have it and one out of
two people with very low kidney function who are not on dialysis do
not know they have CKD.1 Kidney disease is referred to as a
“silent killer” because it often has no symptoms and can go
undetected until a very advanced stage. Each year, kidney disease
kills more people than breast and prostate cancer. Every day, 13
patients in the United States die while waiting for a kidney
transplant.
About Type 2 DiabetesMore than
37 million Americans have diabetes (about 1 in 10), and
approximately 90-95% of them have type 2 diabetes. Type 2 diabetes
most often develops in people over age 45, but more and more
children, teens, and young adults are also developing the disease2.
Type 2 diabetes symptoms often develop over several years and
approximately 23% of adults with type 2 diabetes are undiagnosed3.
Type 2 diabetes affects many major organs, including the heart,
blood vessels, nerves, eyes and kidneys. Diabetic kidney disease
develops in 30-50% of type 2 diabetes patients4.
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 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.
Sources1 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/diabetes/basics/type2.html3
https://www.cdc.gov/diabetes/data/statistics-report/index.html4
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5297507/
Forward Looking
StatementsStatements contained in this announcement
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 and kidneyintelX.dkd,
including whether KidneyIntelX and kidneyintelX.dkd will be
successfully adopted by physicians, inform clinical guidelines,
achieve expanded insurance coverage and be successfully distributed
and marketed, the potential for KidneyIntelX and kidneyintelX.dkd
to be expanded and approved for additional indications and in
additional jurisdictions, our expectations regarding the impact and
benefits of the CMS action on the value or pricing of KidneyIntelX,
our expectations reimbursement decisions, our intellectual property
position, our competitive position and the ability of KidneyIntelX
and kidneyintelX.dkd 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. Inclusion of KidneyIntelX in the
draft KDIGO guidelines does not guarantee inclusion in the final
guidelines. 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 and kidneyintelX.dkd are 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 10-K filed with the
SEC on September 28, 2023, 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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