Renalytix Plc Regulatory News (RENX)

Renalytix AI plc

("RenalytixAI" or the "Company")

Partnership with National Kidney Foundation

to improve management of Early Stage Kidney Disease

Program focused on improving disease management and outcomes beginning at the primary care level

NEW YORK, December 2, 2020  - 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, announces a partnership with the National Kidney Foundation (NKF to improve kidney disease diagnosis and assessment in the earliest stage of the disease that will ultimately guide clinical interventions and treatments for improved outcomes and quality of life.

Kidney disease affects an estimated 37 million adults in the U.S. and can lead to life-threatening kidney failure. Most of those with the disease don't know they have it and won't know until it has progressed to critical late stages.

"We must reach people early in their disease in order to slow or even stop the progression," said NKF Chief Executive Officer Kevin Longino, who is also a kidney transplant recipient. "As a result of this collaboration, we believe lives will be improved and saved."

NKF and RenalytixAI will collaborate for the first time in their histories on future studies to assess current care standards in early stage kidney disease, identify barriers to better care and opportunities for improvement. Long-term initiatives will be developed as the partnership unfolds.

With as many as 90 percent of the people today who have early-stage kidney disease unaware that they have the dangerous disease, scientists, investigators and clinicians are trying to understand how we can increase understanding and promote patient specific care, engagement and monitoring.

KidneyIntelX is an in vitro diagnostic platform that uses a machine learning enabled algorithm to interpret proprietary biomarkers from a simple blood draw and electronic health record features to generate a patient specific risk score for disease progression. The KidneyIntelX risk score categorizes a patient as low, intermediate or high risk for kidney disease progression and kidney failure. The individual patient's score will be integrated with risk appropriate NKF recommended clinical actions and education resources as part of a comprehensive approach to improve outcomes.

"This partnership with RenalytixAI will potentially improve kidney risk stratification, using artificial intelligence to evaluate the combination of important kidney function biomarkers and electronic health record information more accurately than measuring biomarkers alone," said NKF Chief Medical Officer Joseph Vassalotti, MD. "This kidney disease severity information is designed to help Americans living with early stages of kidney disease partner with their primary care clinicians to consider which interventions best fit their individualized risk of kidney failure, including lifestyle modifications, kidney protective medications and whether or not interdisciplinary care with a dietitian and kidney specialist is necessary."

"The partnership with NKF, the leading American kidney patient advocacy organization, will allow RenalytixAI to better consider the patient perspective and leverage the educational resources of the NKF to help improve patient quality of life, reduce suffering and potentially reduce the number of patients suffering from kidney failure," said Michael Donovan, Chief Medical Officer at RenalytixAI.

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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 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. RenalytixAI'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 www.renalytixai.com.

About the National Kidney Foundation

The National Kidney Foundation (NKF) is the largest, most comprehensive, and longstanding patient-centric organization dedicated to the awareness, prevention, and treatment of kidney disease in the U.S. For more information about NKF, visit www.kidney.org.

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 benefits of the partnership between NKF and RenalytixAI and the ability of the partnership to help improve patient quality of life, reduce suffering and potentially reduce the number of patients suffering from kidney failure. Words such as "anticipates," "believes," "estimates," "expects," "intends," "plans," "seeks," and similar expressions are intended to identify forward-looking statements. The plans and objectives disclosed in the forward-looking statements may not actually be achieved, and you should not place undue reliance on these 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; RenalytixAI has only recently commercially launched KidneyIntelX; and risks relating to the impact on RenalytixAI's business of the COVID-19 pandemic or similar public health crises. These and other risks are described more fully in RenalytixAI's filings with the SEC, including the "Risk Factors" section of the Annual Report on Form 20-F for the year ended June 30, 2020. All information in this 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.