Press Release 8

Atrium Health, Wake Forest Baptist Health, Wake Forest School of Medicine and Renalytix Partner to Advance Kidney Health



Partnership marks a long-term commitment to reducing impact of kidney disease in large populations via integration of earlier risk assessment paired with comprehensive disease management

NEW YORK and CHARLOTTE, N.C. and WINSTON-SALEM, N.C., May 19, 2021 (GLOBE NEWSWIRE) -- Renalytix AI plc (LSE: RENX) (NASDAQ: RNLX), Atrium Health, Wake Forest Baptist Health and Wake Forest School of Medicine announced a partnership to implement an advanced clinical care model designed to improve kidney health and reduce kidney disease progression and kidney failure in high-risk populations.

The KidneyIntelX bioprognostic platform for early-stage diabetic kidney disease risk assessment will be available through Atrium Health’s electronic health record (EHR) system, providing access to primary care physicians, endocrinologists, nephrologists and care teams throughout 37 hospitals and more than 1,350 care locations across the Carolinas and Georgia. Charlotte, North Carolina-based Atrium Health serves more than 7 million people in the region, providing care under the Wake Forest Baptist Health name in the Winston-Salem, N.C. region and Atrium Health Navicent in Georgia.  

The partnership with Renalytix enables focused population health initiatives in kidney disease and will provide real-world evidence of optimized delivery of care, improved quality of life, and reduced healthcare costs.  

Renalytix will co-locate personnel in Winston-Salem to support the partnership program with Wake Forest School of Medicine at the Innovation Quarter’s iQ Healthtech Labs, which is the core industry partnership hub of the innovation district. Renalytix and Atrium Health believe the partnership is closely aligned with the core precision medicine and healthy aging sectors that are a focus of iQ Healthtech Labs.

The new program initially targets diabetes-associated kidney disease, a critical healthcare need in the region served by Atrium Health and designated by the Centers for Disease Control and Prevention as the “diabetes belt” and the “kidney disease belt.” In this region in particular, but also nationally and internationally, costs and patient suffering related to diabetes and its associated complications are increasing at unsustainable rates.

“Detecting patients at risk for rapid progression of kidney disease at early, treatable stages is challenging. This effort is critical to optimizing care and improving outcomes using kidney protective medications, specialist referrals and lifestyle changes,” said Barry I. Freedman, M.D., John Felts Professor and Chief of Nephrology at Wake Forest School of Medicine and Chief Medical Officer of Health Systems Management, Inc., the operator of Wake Forest Baptist’s outpatient dialysis clinics. “KidneyIntelX can help us better allocate clinical resources across Atrium Health’s southeastern service region. Patients with diabetic kidney disease at high risk for progression to the need for dialysis or a kidney transplant can be detected earlier and receive intensive blood pressure, blood sugar, cholesterol and lifestyle management and referral to specialists. We expect the outcomes to be very positive for our patients and for our health system.”

“The partnership with Renalytix is a significant milestone in carrying out our commitment to continually innovate to improve population health in our region,” said Terry G. Williams, Chief Population, Corporate and Government Affairs Officer of Atrium Health and executive leader in iQ Healthtech Labs. “Initiatives focused on the generation of unique data-driven insights to improve patient outcomes enable us to deliver effective education and care pathways to improve care and outcomes. Together, we are innovating to achieve clinical excellence and are laying the foundation for patient and physician access to advanced prognostic precision medicine in a major chronic disease.”

“Our commitment to advancing kidney health with KidneyIntelX is strategically aligned with Atrium Health and Wake Forest Baptist Health’s goal to advance care delivery using innovative precision medicine guided care,” said James McCullough, Chief Executive Officer, RenalytixAI. “Renalytix values this opportunity to demonstrate clear, informative evidence of the value of a comprehensive care solution in a region of the United States particularly challenged by diabetic kidney disease. That evidence is important for clinicians, patients, regulators and payers.”

KidneyIntelX is a novel bioprognostic solution that interprets the combination of laboratory results from a simple blood draw and selected electronic health record (EHR) information using a machine learning algorithm. Unlike other solutions available today, the KidneyIntelX risk score assesses a patient’s near-term risk for progressive kidney function decline and failure in the earliest stages of the disease when steps can be taken to preserve kidney health.

The partnership also powers a five-year, multi-center evidence development program across the region, in which patients with chronic kidney disease will receive the KidneyIntelX test as part of a comprehensive care solution to drive quantifiable improvements in patient outcomes. KidneyIntelX will also be made broadly available to patients with both private and government insurance, including Medicare beneficiaries under the Medicare Coverage of Innovative Technology expected to be fully implemented in December 2021. RenalytixAI will be providing financial support to Atrium Health in the form of collaborative research and development, digital health technology deployment, education program delivery and third-party resources in each of these critical areas.

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.2 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 KidneyIntelX

KidneyIntelX, is a first-in-class in vitro diagnostics platform, that employs a proprietary artificial intelligence-enabled algorithm to combine diverse data inputs, including validated blood-based biomarkers, inherited genetics, and personalized patient data from electronic health record, or EHR, systems, to generate a unique patient risk score. This patient risk score enables prediction of progressive kidney function decline in chronic kidney disease, or CKD, allowing physicians and healthcare systems to optimize the allocation of treatments and clinical resources to patients at highest risk.

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, which has been granted Breakthrough Designation by the U.S. Food and Drug Administration and 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 (visit www.kidneyintelx.com). For more information, visit www.renalytixai.com

About Atrium Health

Atrium Health is a nationally recognized leader in shaping health outcomes through innovative research, education and compassionate patient care. Atrium Health is an integrated, nonprofit health system with nearly 70,000 teammates serving patients at 37 hospitals and more than 1,350 care locations. It provides care under the Wake Forest Baptist Health name in the Winston-Salem, North Carolina, region and Atrium Health Navicent in Georgia. Atrium Health is renowned for its top-ranked pediatric, cancer and heart care, as well as organ transplants, burn treatments and specialized musculoskeletal programs. A recognized leader in experiential medical education and groundbreaking research, Wake Forest School of Medicine is the academic core of the enterprise, including Wake Forest Innovations, which is advancing new medical technologies and biomedical discoveries. Atrium Health is also a leading-edge innovator in virtual care and mobile medicine, providing care close to home and in the home. Ranked among U.S. News & World Report’s Best Hospitals for cancer treatment and in eight pediatric specialties, Atrium Health has also received the American Hospital Association’s Quest for Quality Prize and was the recipient of the 2020 Centers for Medicare & Medicaid Services Health Equity Award for its efforts to reduce racial and ethnic disparities in care. With a commitment to every community it serves, Atrium Health seeks to improve health, elevate hope and advance healing – for all, providing more than $2 billion per year in free and uncompensated care and other community benefits.

Sources
1 United States Renal Data System
2 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 of the partnership, 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 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 28, 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.

Media Contacts:

United States:
Jennifer Moritz
Zer0 to 5ive for RenalytixAI
(917) 748-4006
jmoritz@0to5.com

Outside of the United States:
Walbrook PR Limited

Paul McManus / Lianne Cawthorne

Tel: 020 7933 8780 or renalytix@walbrookpr.com
Mob: 07980 541 893 / 07584 391 303