Author Archives: Jmoritz0to5

Renalytix Convenes Expert Panel at VA Healthcare Summit

Leading clinicians discuss enabling long-term kidney health in Veterans with type 2 diabetes and early-stage chronic kidney disease

 NEW YORK and SALT LAKE CITY, November 10, 2021 – In recognition of National Diabetes Month and concurrent with the launch of KidneyIntelX in the Veterans Health Administration health system, Renalytix (NASDAQ: RNLX) (LSE: RENX) convened a multidisciplinary panel to discuss advances in kidney health through early-stage prognosis and intervention of chronic kidney disease (CKD) in patients with type 2 diabetes. Clinical experts shared patient case studies drawing from their experience adding KidneyIntelX into clinical care. The KidneyIntelX enabled care pathway being implemented in the Mount Sinai Health System is a model that can be used in implementing the new Veterans Health Administration CKD Directive and joint VA and Department of Defense guideline, driving care earlier to prevent progression and kidney failure. The panel event took place at The Institute for Defense and Government Advancement (IDGA) VA Healthcare Summit on Wednesday, October 27, 2021.

The panel, “Breakthrough Diagnostic Approach for Type 2 Diabetes and Early-Stage Chronic Kidney Disease (CKD): Today’s Precise Answer, Tomorrow’s Kidney Health,” included renowned thought leaders who highlighted the importance of early detection and intervention to promote long-term kidney health and improve clinical outcomes in their type 2 diabetes patients.  

Commenting on the Summit discussion, panelists said:

Michael J. Donovan, PhD, MD, Chief Medical Officer at Renalytix: “This roundtable discussion provided a unique opportunity for clinical experts to highlight the impact of KidneyIntelX risk assessment on patient-specific management decisions. Their remarks highlighted how KidneyIntelX testing can help address the challenges they face when relying on current clinical tools. The panel also reviewed the practice-changing evidence from recent therapeutic trials. The discussion underscored the importance of a systems approach to managing care for chronic kidney disease patients given the intimate association of cardiovascular and kidney function.”

David Lam, MD, Assistant Professor of Medicine (Endocrinology, Diabetes and Bone Disease) at the Icahn School of Medicine at Mount Sinai and Medical Director at the Mount Sinai Clinical Diabetes Institute, NYC, NY: “As an endocrinologist, I see patients living with diabetes day in and day out. Diabetes care is a team effort. I co-manage diabetic patients with other trained professionals, all working towards the care of patients to help them thrive.  KidneyIntelX has helped me to identify patients with early-stage diabetic kidney disease earlier and has enabled me to deploy the right care path, direct care resources and provide treatment guidance based on my patients’ risk level at the right time.”

 

 

Joseph Vassalotti, MD, FASN, Clinical Professor of Medicine (Nephrology) at Icahn Mount Sinai and Chief Medical Officer of the National Kidney Foundation, NYC, NY: “13.1 % of the US population has diabetes, most with type 2 diabetes, but about 40% also have low kidney function and/or increased albumin, a type of protein, in the urine.  Early risk stratification for these patients with kidney disease informs their care management. KidneyIntelX combines biomarkers and the data from the patients’ health record, to produce a risk score that is easy to understand.  For patients, reviewing the results of that risk score helps motivate them to take additional action toward their kidney health that is proportional to the risk. As a nephrologist it helps me think about the types of lifestyle modification, patient engagement, medication management and interdisciplinary care that is optimal for my patients.”

Katherine Tuttle, MD, FASN, FACP, FNKF, Professor of Medicine in Nephrology at the University of Washington, the Executive Director for Research at Providence Health Care, and a Co-Principal Investigator at the Institute for Translational Health Sciences: “KidneyIntelX leads into more effective therapeutic management which should lead to improved outcomes in a value-based system. For example, heart failure and chronic kidney disease occur concomitantly. If we reduce heart failure hospitalization by identifying and managing higher risk patients more effectively, that would be a huge savings to the health care system.  If we also prevent cases of kidney failure, and the costs associated with treating patients with kidney failure, we will realize enormous cost savings. The triangulation between diabetes, heart failure and chronic kidney disease accounts for one third of the Medicare budget and this cost is extensive in the veteran population as well.”

As the largest integrated health care network in the United States, the U.S. Department of Veterans Affairs is tasked with providing care to America’s Veterans. One in four veterans have diabetes and many have comorbid conditions including kidney disease. Renalytix is committed to promoting kidney health in veterans by aligning care models that proactively protect kidneys from avertable harm.

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 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.

About Renalytix

Renalytix (NASDAQ: RNLX) (LSE: RENX) is the global founder and leader in the new field of bioprognosisTM 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.

KidneyIntelX is based on technology developed by Mount Sinai faculty and licensed to Renalytix, and is currently utilized in sponsored research by Renalytix at Mount Sinai. Mount Sinai and Mount Sinai faculty, including Dr. Steve Coca and Dr. Girish Nadkarni, have a financial interest in Renalytix. Mount Sinai has representation on the Renalytix Board of Directors.

 

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.

 

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.

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 bioprognosisTM 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.

Mount Sinai Initiates System-wide Scale-Up of Renalytix KidneyIntelX™ Enabled Health Care Model

Targeted testing run rate of 300 diabetic kidney disease patients per week in calendar Q4 2021

NEW YORK and SALT LAKE CITY, September 14, 2021 – Renalytix plc (NASDAQ: RNLX) (LSE: RENX) and the Mount Sinai Health System today announced scaled-up implementation of the KidneyIntelX™ early-stage risk assessment testing and care management program across primary care and specialty clinician networks under a real-world evidence development program for patients with diabetic kidney disease (DKD). KidneyIntelX enables a shift in focus from care coordination efforts focused on Mount Sinai’s late-stage kidney disease patients to a focus on patients with early stages of the disease where prognosis and treatment with population health care navigation assistance can improve patient care and outcomes and generate cost savings. Before the end of 2021, Mount Sinai expects to provide KidneyIntelX testing and downstream care management at a rate of 300 patients per week with approximately 6,000 eligible patients tested by calendar Q2 2022 under this development program.

In an initial rollout across seven primary care practices in Manhattan, New York City, the KidneyIntelX program has demonstrated value for clinical care delivery by identifying patients with DKD at low, intermediate, and high risk of declining kidney function or kidney failure early in the disease lifecycle when treatment has the potential for maximum effect. KidneyIntelX access is now expected to grow to over 300 treating physicians in calendar Q4 2021. The number of eligible patients who have scheduled physician interaction with active electronic health record access to KidneyIntelX is expected to grow up to sixfold in the same period.

“Our KidneyIntelX enabled diabetic kidney disease program allows us to provide a high standard of care in early-stage kidney disease patients where we have the best chance to help patients avoid significant kidney damage,” said Robert Fields, MD, MHA, Executive Vice President and Chief Population Health Officer at Mount Sinai Health System. “Ongoing analysis and sharing of doctor and patient user experience combined with population level data insights is helping to drive systemwide access to early-stage risk-assessment and treatment.”

“Systematically identifying high-risk patients with DKD under primary care at the earliest stages of their disease is essential for improving outcomes, quality of life, and reducing health care cost in the population with kidney disease,” said David C. Thomas, MD, Professor of Medicine, Medical Education and Rehabilitation and Human Performance and Interim System Chair, Department of Medicine, Icahn School of Medicine at Mount Sinai. “We now have the tools, including care navigation, and pharmacy and dietician support, in place to do more than manage the transition to dialysis or transplant. We believe this program will enable advanced support for our primary care teams to help improve the long-term outlook and quality of life for our patients with diabetic kidney disease.”

In 2021, Mount Sinai’s KidneyIntelX enabled care program has achieved significant milestones, including successful integration into the clinical workflow across the Health System’s network of primary care and specialty physician practices.  Early results of the real-world evidence program are aligned with published utility study data. These results indicate that appropriate pharmacy management and specialist referrals are more likely when KidneyIntelX testing is integrated into the care plan. These actions are important for slowing the progression of DKD. Under Mount Sinai’s population health guided care model, primary care physicians can receive direct test ordering, education and advanced pharmacy, dietary and specialist support information for their DKD patients.

KidneyIntelX includes technology that was initially developed by Mount Sinai faculty. This technology has been licensed by Mount Sinai to Renalytix. Mount Sinai and a small number of Mount Sinai faculty inventors have a financial interest in Renalytix. Mount Sinai also has representation on the Renalytix Board of Directors.

About KidneyIntelX

KidneyIntelX is a first-of-kind solution that enables early-stage diabetic kidney disease 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 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 Renalytix

Renalytix (LSE: RENX) (NASDAQ: RNLX) is the global founder and leader in the new field of bioprognosisTM 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 is 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 the Mount Sinai Health System

The Mount Sinai Health System is New York City’s largest academic medical system, encompassing eight hospitals, a leading medical school, and a vast network of ambulatory practices throughout the greater New York region. We advance medicine and health through unrivaled education and translational research and discovery to deliver care that is the safest, highest-quality, most accessible and equitable, and the best value of any health system in the nation. The Health System includes approximately 7,300 primary and specialty care physicians; 13 free-standing joint-venture centers; more than 410 ambulatory practices throughout the five boroughs of New York City, Westchester, and Long Island; and more than 30 affiliated community health centers. The Mount Sinai Hospital is ranked in U.S. News & World Report’s “Honor Roll” of the top 20 U.S. hospitals and among the top in the nation by specialty: No. 1 in Geriatrics and top 20 in Cardiology/Heart Surgery, Diabetes/Endocrinology, Gastroenterology/GI Surgery, Neurology/Neurosurgery, Orthopedics, Pulmonology/Lung Surgery, Urology, and Rehabilitation. Mount Sinai Kravis Children’s Hospital is ranked in U.S. News & World Report’s “Best Children’s Hospitals” among the country’s best in four out of 10 pediatric specialties. New York Eye and Ear Infirmary of Mount Sinai is ranked among the Top 20 nationally for ophthalmology. The Icahn School of Medicine at Mount Sinai is one of three medical schools that have earned distinction by multiple indicators: ranked in the top 20 by U.S. News & World Report’s “Best Medical Schools,” aligned with a U.S. News & World Report “Honor Roll” Hospital, and No. 14 in the nation for National Institutes of Health funding. Newsweek’s “The World’s Best Smart Hospitals” ranks The Mount Sinai Hospital as No. 1 in New York and top five globally, and Mount Sinai Morningside as top 20 globally, and “The World’s Best Specialized Hospitals” ranks Mount Sinai Heart as No. 1 in New York and No. 5 globally and the Division of Gastroenterology as No. 5 globally. For more information, visit https://www.mountsinai.org or find Mount Sinai on Facebook, Twitter

and YouTube.

 

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 commercial prospects of KidneyIntelX, including whether KidneyIntelX will be successfully adopted by physicians and distributed and marketed, the rate of testing with KidneyIntelX in health care systems, expectations and timing of announcement of real-world testing evidence, the potential for KidneyIntelX to be approved for additional indications, 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.

Payer Budget Impact Analysis Projects Significant Savings from KidneyIntelX Testing at Primary Care Level

Peer reviewed publication in Journal of Medical Economics supports payer coverage for early-stage risk assessment and care management in the primary care office

 NEW YORK and SALT LAKE CITY, August 26, 2021 – Renalytix Plc (NASDAQ: RNLX) (LSE: RENX) today announced the publication of results from an external chronic kidney disease budget impact analysis projecting 5-year savings of $1.1 billion for a population of 100,000 patients with type 2 diabetes (T2DKD) and chronic kidney disease tested with the Renalytix KidneyIntelX™ testing solution. Savings were driven by more effective pharmacy management and appropriate specialist referral compared to current standard of care for patients at high risk for disease progression and kidney failure.

The detailed clinical and cost analysis concluded that health systems and insurance plans would realize these significant cost savings based on slowed disease progression (52% of savings), delayed, or prevented dialysis and transplants (32% of savings), and reduced dialysis crashes (11% of savings). Given the costs associated with current standard of care, the addition of an actionable bioprognosticTM approach to predict kidney function decline in T2DKD patients, stages 1-3b resulted in a projected 5-year savings of $1.1 billion associated with KidneyIntelX.

“These findings are significant and further demonstrate that predicting kidney disease risk at its earliest stages – when it matters most – is a major benefit to patients, providers and payers,” said CDPHP president and CEO, Dr. John D. Bennett.

Budget impact analysis (BIA) is a key element in securing payer coverage in the U.S. market. BIA is an economic assessment that estimates the financial consequences of adopting a new, high value intervention like KidneyIntelX. The analysis takes a payer’s perspective to evaluate whether a new intervention is affordable. It uses a short-term time horizon, up to 5 years. The model analyzes the direct costs of specific resources needed to implement KidneyIntelX informed care in the PCP office with savings associated with changes in care delivery. That result is multiplied by the number of people affected by the intervention. The results of the analysis provide an understanding of the total budget required to provide the intervention. The size of the population is explicitly considered for this analysis. The focus of a BIA is the direct costs of specific resources needed to put the intervention into effect, such as testing, pharmacy management, and specialist care. Consistent with best practices, sensitivity analyses were conducted to evaluate the impact of core assumptions related to physician compliance and disease progression.

Renalytix will further expand its health economic and utility evidence through separate cost-effectiveness analyses evaluating whether intervention with KidneyIntelX testing provides value, defined as cost relative to health outcome, relative to current standard of care. These analyses will be completed in conjunction with three large real-world evidence studies with Mount Sinai Health System, Wake Forest/Atrium Health and University of Utah Health.

The budget impact model was developed in collaboration with Boston Healthcare Associates (BHA), an external firm, in accordance with the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) good practices. BHA researchers evaluated the budget impact of management using KidneyIntelX as compared with standard of care over a 5-year horizon in patients with diabetic kidney disease (DKD). Results are detailed in, “Payer Budget Impact of an Artificial Intelligence In Vitro Diagnostic to Modify Diabetic Kidney Disease Progression,” published in the Journal of Medical Economics.

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.

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

About KidneyIntelXTM

KidneyIntelX, is a first-of-kind, 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 Renalytix

Renalytix (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 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.

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 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.