Renalytix plc

("Renalytix" or the "Company")

St. Joseph's Health and Renalytix Partner to Advance Value-Based Kidney Health

in New York

Partnership expands doctor and patient access to advanced prognosis and coordinated care management of early-stage diabetic kidney disease 

NEW YORK, November 9, 2021 - St. Joseph's Health and Renalytix plc (NASDAQ: RNLX) (LSE: RENX) today announced a partnership to implement an advanced clinical care model designed to improve kidney health in patients with type 2 diabetes and early-stage chronic kidney disease. The Renalytix KidneyIntelX™ platform will be integrated with St. Joseph's Health care management to help prevent patients with diabetes and early-stage kidney disease from unnecessarily progressing to significant disease and/or kidney failure. KidneyIntelX is designed to enable primary care and specialist physicians to easily understand risk and implement St. Joseph's Health medication management, nutrition and education intervention protocols on a timely basis. 

St. Joseph's Health is part of Trinity Health, one of the largest multi-institutional Catholic health care delivery systems in the U.S., serving diverse communities that include more than 30 million people across 25 states. KidneyIntelX test risk assessment will be available through St. Joseph's Hospital's electronic health record (EHR) system, providing access to primary care physicians, endocrinologists, nephrologists, and care teams.

"A challenge in healthcare is that approximately 35 million people have been diagnosed with diabetes and 20% of those patients with diabetes will progress to kidney failure. The Renalytix IVD test is the first tool to enable early-stage progression risk assessment in early diabetic kidney disease," said Paul Fiacco, MD, Medical Director, Trinity Health Integrated Care ACO and President of CNY AIM (a clinically integrated network affiliated with St. Joseph's Health). "This risk assessment allows primary care clinicians to provide early intervention to their identified high-risk patients to prevent future disease progression to kidney failure. This partnership with Renalytix is motivated by our common desire to expand our value proposition to larger populations and further strengthen our population health management capabilities." 

"St. Joseph's Health is involved in several different value-based, accountable care agreements, including, but not limited to, the Medicare Shared Savings Program and the Excellus Blue Cross Blue Shield's Accountable Cost Quality Agreement," said Mike Endries, Executive Director, CNY AIM (www.cnyaim.org). "These accountable care agreements encourage our providers to employ population health management initiatives and to engage with patients in the early identification and treatment of chronic disease. The partnership with Renalytix furthers our efforts to create a physician-led, people-centered health care system that improves the health care outcomes of our patients, specifically those who may be at risk for early-stage CKD." 

"St. Joseph's Health shares our forward-thinking, patient-centric approach to changing the standard of care in kidney health. St. Joseph's Health's early-stage chronic kidney disease care model, powered by KidneyIntelX, is expected to drive improved clinical and cost outcomes to make healthier kidneys both attainable and sustainable," said Christine Loftsgaarden, VP, Commercial Partnerships at Renalytix.

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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 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 St. Joseph's

St. Joseph's Health is a regional non-profit health care system based in Syracuse, NY. St. Joseph's has been an innovative leader in health care since our founding in 1869 as the first hospital open to the public in the city of Syracuse. Offering primary, specialty and home care, a Magnet-recognized hospital, and collaboration with community partners, St. Joseph's Health advances the well-being of the communities we serve through an expanding range of services to ensure our patients achieve optimum long-term health. St. Joseph's is one of America's 50 Best Hospitals for Cardiac Surgery and one of America's 100 Best for Spine Surgery and Coronary Intervention according to Healthgrades. It is ranked by Consumer Reports among the top 15 heart surgery centers in the country, a designated Stroke Center and a U.S. News "Best Regional Hospital." St. Joseph's Health is affiliated with St. Joseph's Physicians, and is a member of Trinity Health. For more information, visit www.sjhsyr.org/legacy.

About Renalytix

Renalytix (NASDAQ: RNLX) (LSE: RENX) 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, 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.

About KidneyIntelX

KidneyIntelX, is a first-of-kind solution that enables early-stage diabetic kidney diseases (DKD) 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 CKD, allowing physicians and healthcare systems to optimize the allocation of treatments and clinical resources to patients at highest risk.

Sources

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

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 benefits, including economic savings, of KidneyIntelX, the potential for KidneyIntelX to receive regulatory approval from the FDA, the commercial prospects of KidneyIntelX, if approved, including whether KidneyIntelX will be successfully adopted by physicians and distributed and marketed, 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 21, 2021, 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.