TIDMRENX

Renalytix AI PLC

03 January 2020

3 January 2020

Renalytix AI plc

("RenalytixAI", the "Company" or the "Group")

CMS Pricing Determination becomes effective

Renalytix AI plc (AIM: RENX), a developer of artificial intelligence enabled clinical diagnostics for kidney disease, announces that that the national price for KidneyIntelX(TM) set by the Centers for Medicare and Medicaid Services ("CMS") became effective as of 1 January 2020. This establishes a national price of $950 for the test for Medicare patients and is effective until December 2022.

This announcement follows the publication of the final 2020 Clinical Laboratory Fee Schedule ("CLFS") by CMS, announced by the Company on 3 December 2019 (RNS: 4621V). For patients covered by Medicare the national price paid for outpatient laboratory testing is established through the CLFS process. Each year, new laboratory test codes are added to the CLFS and pricing is developed through a public comment process and review and finalisation by CMS. The pricing for tests like KidneyIntelX(TM) is set for a three-year period. At the end of that time, the price will be reset based on an average of reported private payor payments for the test or laboratory service. If the calculated average price would result in a reduction in the price paid for KidneyIntelX(TM) for Medicare patients, the decrease will be capped at no more than 15%.

Leveraging the validation associated with a national price established by Medicare, the Company is pursuing coverage determinations in 2020 and 2021 to ensure KidneyIntelX(TM) is available to patients with public and private health insurance coverage throughout the United States.

The person responsible for arranging the release of this announcement on behalf of the Company is James McCullough, CEO.

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 / Jonathan Senior / Ben Maddison 
 
N+1 Singer (Joint Broker)                                                            Tel: 020 7496 3000 
Aubrey Powell / George Tzimas (Corporate Finance) 
Tom Salvesen / Mia Gardner (Corporate Broking) 
 
Walbrook PR Limited                                      Tel: 020 7933 8780 or renalytix@walbrookpr.com 
Paul McManus / Lianne Cawthorne                                          Mob: 07980 541 893 / 07584 391 
                                                                                                    303 
 
 

About Kidney Disease

Kidney disease is now recognised as a public health epidemic affecting over 850 million people globally. The Centers for Disease Control estimates there that 15% of United States adults or 37 million people currently have chronic kidney disease. It is reported 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 die in the United States while waiting for a kidney transplant.

* https://www.cdc.gov/kidneydisease/publications-resources/2019-national-facts.html

About RenalytixAI

RenalytixAI 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 products are being designed to make significant improvements in kidney disease diagnosis, transplant management, clinical care, patient stratification for drug clinical trials, and drug target discovery.

For more information, visit renalytixai.com

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.

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