Renalytix AI PLC Finalization of MCIT rule for coverage pathway (4713L)
January 13 2021 - 1:00AM
UK Regulatory
TIDMRENX
RNS Number : 4713L
Renalytix AI PLC
13 January 2021
This announcement contains inside information
Renalytix AI plc
("RenalytixAI" or the "Company")
Renalytix Commends HHS/CMS on Finalization of MCIT Rule to
Provide National Medicare Coverage for FDA Breakthrough Devices and
Diagnostics
Creates Pathway for Beneficiary Access to KidneyIntelX for
Medicare Beneficiary Kidney Disease Populations
NEW YORK, January 13, 2021 - Renalytix AI plc (LSE : RENX)
(NASDAQ: RNLX), an artificial intelligence-enabled in vitro
diagnostics company, focused on optimizing clinical management of
kidney disease to drive improved patient outcomes and advance
value-based care , notes that the Centers for Medicaid &
Medicare (CMS) announced the establishment of the Medicare Coverage
of Innovative Technology (MCIT) pathway (RIN: 0938-AT88 ) to
provide a coverage pathway for Medicare beneficiaries nationwide to
have faster access to new, innovative medical devices and
diagnostic tests designated under the Breakthrough Device review
program and with market authorization by the U.S. Food and Drug
Administration (FDA). Under MCIT, national Medicare coverage can
become effective on the date of FDA approval or clearance of a
breakthrough designated device and will continue for a period of
four years. After a four-year period, continued coverage for
Medicare beneficiaries will be based on one of three methods, 1)
case-by-case coverage, 2) a local coverage determination, or 3) a
national coverage determination.
"Having a clear path to national Medicare coverage for
innovative products like KidneyIntelX provides a major catalyst to
drive the robust research and clinical development programs
necessary to address major unmet medical needs such as kidney
disease," stated Tom McLain, President, RenalytixAI. "MCIT will
also encourage early engagement with FDA in developing new
diagnostic tests and leverage the many benefits of Breakthrough
Designation including priority review of needed technology. We
appreciate the opportunity to work with FDA and CMS to tackle the
critical issue of early-stage prognosis to help slow or prevent
kidney disease progression. This new coverage pathway will
facilitate accelerated access to KidneyIntelX for Medicare
beneficiaries and their primary care doctors to help assure a
better quality of life and save lives."
RenalytixAI's lead product, KidneyIntelX, was granted FDA
breakthrough designation in May 2019 . After working closely with
the FDA review team assigned to KidneyIntelX the company submitted
its DeNovo 510K application for clearance in August 2020. Assuming
FDA clearance is received in 2021, Renalytix will opt in for the
automatic four-year National Medicare coverage period. In addition
to the MCIT coverage pathway for the test, Renalytix has already
designed a prospective utility and outcome study. The aim of the
two thousand patient study is to further demonstrate the clinical
value of KidneyIntelX testing in delaying or preventing the
progression of early-stage diabetic kidney disease.
For further information, please contact:
Renalytix AI plc www.renalytixai.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
The person responsible for this announcement is James
McCullough, CEO.
About Kidney Disease
Kidney 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, or 37
million people, currently have chronic kidney disease (CKD).
Further, the CDC reports that 9 out of 10 adults with CKD do not
know they have it and 1 out of 2 people with very low kidney
function who are not on dialysis do not know they have CKD*. 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.
*
https://www.cdc.gov/kidneydisease/publications-resources/2019-national-facts.html
About RenalytixAI
RenalytixAI (LSE: RENX) (NASDAQ: RNLX) is a developer of
artificial intelligence-enabled clinical in vitro diagnostic
solutions for kidney disease, one of the most common and costly
chronic medical conditions globally. The Company's lead product is
KidneyIntelX.com (visit www.kidneyintelx.com ) which is being
designed to help make significant improvements in kidney disease
prognosis, transplant management, clinical care, patient
stratification for drug clinical trials, and drug target discovery.
For more information, visit www.renalytixai.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 potential for KidneyIntelX to
receive regulatory approval from the FDA, the commercial prospects
of KidneyIntelX, if approved, including whether KidneyIntelX will
be successfully distributed and marketed, our ability to take
advantage of the MCIT program, 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 final prospectus filed with the SEC on July
17, 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
MSCDKBBQNBKBADD
(END) Dow Jones Newswires
January 13, 2021 02:00 ET (07:00 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