Renalytix PLC Update on MCIT Rule (7773L)
15 September 2021 - 3:14AM
UK Regulatory
TIDMRENX
RNS Number : 7773L
Renalytix PLC
14 September 2021
This announcement contains inside information
Renalytix plc
("Renalytix" or the "Company")
Update on MCIT Rule
to Provide National Medicare Coverage for FDA Breakthrough
Devices and Diagnostics
NEW YORK, September 14, 2021 - Renalytix plc (NASDAQ: RNLX) (LSE
: RENX) provides an update on developments related to the Medicare
Coverage of Innovative Technology (MCIT) rule to provide a coverage
pathway for Medicare beneficiaries to access FDA-cleared or
approved breakthrough devices during an initial four year period
after FDA clearance or approval.
Following a previously announced delay in the implementation of
the final rule establishing the MCIT pathway, the Centers for
Medicare & Medicaid Services (CMS) issued a proposal to repeal
the final rule prior to implementation on December 15, 2021. CMS
stated that it believes there are other ways to achieve the goal of
providing innovation and access to important new technologies
including future policies and potential rulemaking. CMS is now
providing a public comment period to allow stakeholders to provide
input on the proposed repeal.
Independent of MCIT, Renalytix has continued to develop clinical
evidence to support Medicare coverage at the local level from a
Medicare Administrative Contractor (MAC), which it could receive as
early as mid-calendar 2022. Coverage from a MAC would allow for
Medicare reimbursement at $950 for any Medicare beneficiary in the
United States receiving KidneyIntelX testing. The Company will
continue to build revenue momentum this year with Mount Sinai
Health System, under the General Services Administration-awarded
contract, and through other private and public payers.
James McCullough, CEO, commented: "The proposed repeal of the
rule is a disappointing setback for diagnostic innovation. Given
our trajectory for accumulating real-world utility evidence,
however, we do not believe there will be a material impact on the
KidneyIntelX business plan and are confident of continuing success
to secure comprehensive government and private insurance
reimbursement for KidneyIntelX."
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 .
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.
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
RNS may use your IP address to confirm compliance with the terms
and conditions, to analyse how you engage with the information
contained in this communication, and to share such analysis on an
anonymised basis with others as part of our commercial services.
For further information about how RNS and the London Stock Exchange
use the personal data you provide us, please see our Privacy
Policy.
END
MSCSFUFWLEFSESU
(END) Dow Jones Newswires
September 14, 2021 13:14 ET (17:14 GMT)
Renalytix (LSE:RENX)
Historical Stock Chart
From Apr 2024 to May 2024
Renalytix (LSE:RENX)
Historical Stock Chart
From May 2023 to May 2024