Renalytix Plc Regulatory News (RENX)

Renalytix AI plc

("RenalytixAI" or the "Company")

RenalytixAI Expands Core Investigator Group

for Kidney Transplant Advanced Diagnostic Programme

Investigators now include transplant experts from University of Oxford, Yale School of Medicine, Emory University School of Medicine, Icahn School of Medicine at Mount Sinai, University of Manitoba, Westmead Hospital Sydney, University of Alabama at Birmingham, and Cleveland Clinic

Renalytix AI plc (AIM: RENX), a developer of artificial intelligence-enabled clinical diagnostics for kidney disease, announces the expansion of the core investigator group supporting clinical and regulatory pathways for FractalDx, a portfolio of advanced diagnostic and prognostic solutions in kidney transplant.

As previously announced, RenalytixAI formed the FractalDx investigator group as part of its commercial programme for advanced diagnostic tests expected to make significant improvements in the identification and monitoring for kidney transplant rejection, and to aid in accurate dosing of immune-suppression therapy.

Kathryn Wood, DPhil, Professor of Immunology Emerita in the Nuffield Department of Surgical Sciences at the University of Oxford, said: "Predicting transplant rejection before damage to the transplanted kidney occurs remains a major unmet need. Accurately determining rejection risk for each transplant recipient allows individualised treatment to be initiated before the transplanted kidney is attacked and damaged by the immune system leading to improved patient care and successful outcomes."

The number of kidney transplants steadily rises each year in the United States and worldwide1 with nearly 20 percent of transplants failing within three years2. This highlights the critical need for solutions that will address patient impact and the growing cost of medical treatment associated with kidney transplant complications.

Dr. Barbara Murphy, Dean for Clinical Integration and Population Health, Professor and System Chair Medicine and Nephrology, at the Icahn School of Medicine at Mount Sinai, and Chair of the Scientific Advisory Board of RenalytixAI, said: "As the need for kidney transplantation continues to increase due to the rapid growth of the chronic kidney disease (CKD) epidemic, we must determine a way to assess risk of organ rejection and personalise treatment for each and every patient. Our expanded group of investigators will help us in the ongoing development of prognostic and diagnostic solutions to help address the crucial shortfalls we're currently facing in the area of kidney transplantation."

The investigator appointments now include:

· Richard Formica, MD - Professor of Medicine (Nephrology) and Professor of Surgery (Transplant); Director of Transplant Medicine; Director Outpatient Transplantation Service; Medical Director Adult and Pediatric Kidney Transplantation; and Medical Director Pancreas Transplantation at Yale School of Medicine

· Christian P. Larsen, MD, DPhil - Professor of Surgery, Division of Transplantation, Department of Surgery and the former dean of the Emory University School of Medicine, and Founding Director of the Emory Transplant Center

· Roslyn B. Mannon, MD - Professor of Medicine in the Division of Nephrology and Professor of Surgery in the Division of Transplantation at the University of Alabama at Birmingham, and Director of Research for the Comprehensive Transplant Institute

· Barbara Murphy, MD - Dean for Clinical Integration and Population Health, Professor and System Chair Medicine and Nephrology, at the Icahn School of Medicine at Mount Sinai

· Peter Nickerson, MD, FRCPC - Clinical Nephrologist, Professor of Internal Medicine and Immunology, and Associate Dean for Research at the University of Manitoba, and Executive Medical Director, Organs and Tissue Office, at the Canadian Blood Services

· Philip O'Connell, MD - Clinical Professor in Medicine, Director of the Centre for Transplant and Renal Research at the Westmead Institute for Medical Research, and Director of Transplant Medicine and the Clinical Islet Transplant Program at the Westmead Hospital Sydney

· Emilio D. Poggio, MD, FASN - Professor of Medicine at the Cleveland Clinic Lerner College of Medicine of CWRU, and Medical Director, Kidney and Kidney Pancreas Transplant Program, at the Cleveland Clinic

· Kathryn Wood, DPhil - Professor of Immunology Emerita in the Nuffield Department of Surgical Sciences at the University of Oxford

· Weijia Zhang, PhD - Director, Integrative Bioinformatics and Professor of Medicine, at the Icahn School of Medicine at Mount Sinai

The FractalDx technology is based principally on sequencing biomarkers from a patient's blood using widely available instrument platforms. Products under development from the portfolio are anticipated to be part of the extended RenalytixAI pipeline following the introduction of KidneyIntelX in 2019 for the diagnosis of fast-progressing chronic kidney disease.

As outlined in an announcement on 2 January, 2019, RenalytixAI had exercised its option from the Icahn School of Medicine at Mount Sinai ("ISMMS") for the exclusive license to technology and data underlying the FractalDx product portfolio. The Company is expected to initiate the clinical validation for the first diagnostic product from the portfolio beginning in the second half of 2019.

Notes:

[1] United Network for Organ Sharing (UNOS), 2019

[2] National Kidney Foundation, 2019

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

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About Kidney Disease 

Kidney disease is now recognized as a public health epidemic affecting over 850 million people globally. In the United States alone, over 40 million people are classified as having chronic kidney disease, with nearly 50 percent of individuals with advanced (Stage IV) disease unaware of the severity of their reduced kidney function. As a result, many patients progress to kidney failure in an unplanned manner, ending up having dialysis in the emergency room without ever seeing a clinical specialist, such as a nephrologist. Every day 13 patients die in the United States while waiting for a kidney transplant.

About RenalytixAI

RenalytixAI is a developer of artificial intelligence-enabled clinical diagnostic solutions for kidney disease, one of the most common and costly chronic medical conditions globally. The Company's solutions are being designed to make significant improvements in kidney disease diagnosis and prognosis, clinical care, patient stratification for drug clinical trials, and drug target discovery. For more information, visit renalytixai.com.