Author Archives: ShawnZer05

KidneyIntelXTM Enables Monitoring of SGLT2 Inhibitor Therapy Response and Corresponding Risk Reduction Over Time

Study Results lay foundation for KidneyIntelX repeat testing, reimbursement, and pharma collaborations

NEW YORK, June 28, 2021 – Renalytix plc (LSE: RENX) (NASDAQ: RNLX) announces new data demonstrating KidneyIntelX™ can be effective at monitoring therapeutic response and  improvements in kidney health over time in adults with type 2 diabetes.  By accurately assessing therapeutic response, particularly in patients at high risk for kidney failure, KidneyIntelX can potentially address a major barrier for primary care physicians and specialists in using new pharmaceuticals to slow kidney disease and improve outcomes. The data from an international study of 1,100 individuals with diabetic kidney disease (DKD) in the CANagliflozin Cardiovascular Assessment Study (CANVAS), was presented at the American Diabetes Association 81st Scientific Sessions Virtual Meeting (June 25-29, 2021).

“Until now, primary care physicians have not had an optimal way to assess risk for kidney disease progression in their type 2 diabetes patients. KidneyIntelX provides early risk stratification which allows us to optimize and target patients in early stages of kidney disease with new medications such as SGLT2i, and moreover, these data support how KidneyIntelX can help monitor these patients and their response to treatment. It helps address an unmet need and gives the PCP a better call to action in the monitoring and effective pharmacy management of patients,” said Marina Basina, Clinical Professor of Medicine (Endocrinology) at Stanford University School of Medicine.

These results will be further evaluated through a growing body of real-world evidence and clinical effectiveness data driven by the KidneyIntelX multi-institutional study network in over 6,000 patients. The network is assessing the ability of KidneyIntelX to 1) to appropriately risk stratify patients in early stage (stage 1, 2 and 3) kidney disease; 2) help guide the optimal medication regimen based on individualized risk assessment; and 3) monitor therapeutic response and kidney health using repeat testing over time. KidneyIntelX is being deployed to manage DKD populations beginning at primary care level in partnership with large health care systems including the University of Utah, the Mount Sinai Health System, and Atrium Health, Wake Forest Baptist Health.

“The ability of KidneyIntelX to assess SGLT2 inhibitor response and improvements in kidney health through repeat testing is a significant step towards broader utilization of new therapeutic agents to significantly reduce the risk of kidney failure. This is another demonstration of the unique value of the KidneyIntelX bioprognostic solution to assist in early and effective care management of the 12 to 15 million adults in the United States with diabetes and chronic kidney disease,” said Michael J. Donovan, CMO at Renalytix.

The oral presentation titled, “Longitudinal Changes in KidneyIntelX and Association with Progressive Decline in Kidney Function in the CANVAS Trial,” was presented at the American Diabetes Association 81st Scientific Sessions Virtual Meeting (June 25-29, 2021). The new analysis based on data from the CANVAS trial demonstrated that canagliflozin reduced the KidneyIntelX risk score compared with a placebo over time, and that changes in the KidneyIntelX score from baseline to one year were strongly prognostic for future risk of DKD progression, whether the changes were treatment-induced or due to natural disease progression.

These data are the second output in a series of analyses of the CANVAS cohort in conjunction with Janssen Research and Development including the role of KidneyIntelX in treatment decisions and monitoring therapeutic effect. The first set of results were presented earlier this year in April at the World Congress of Nephrology which demonstrated that KidneyIntelX is effective in identifying high risk patients with DKD who are more likely to benefit from aggressive pharmaceutical management to slow progression.

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 KidneyIntelX

KidneyIntelX, is a first-of-kind, bioprognosticTM 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 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.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 of repeat testing with 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.

 

 

Leadership Additions Announced to Support Expanding US Government and Healthcare Provider KidneyIntelX Deployment

Enabling expertise in sales, population health and value-driven care models

NEW YORK and SALT LAKE CITY, June 7, 2021 – Renalytix AI plc (LSE: RENX) (NASDAQ: RNLX) today announced a series of key hires to drive its commercialization strategy in the United States market in light of the recently announced Federal Government General Service Administration payment contract and additional large healthcare system partnerships. The combined background and experience of the new leadership team is expected to drive adoption of the KidneyIntelX testing and care model implementation in early-stage diabetic kidney disease populations.  Renalytix expects to continue expanding its sales, marketing, and implementation teams with expected KidneyIntelX roll-out beginning in the VA Medical Health System in the 2nd half of 2021, and as the Company positions for a broader national expansion beginning in fiscal 2022 in line with expectations for a national Medicare insurance coverage determination later this year.

Renalytix welcomes:

Missy Martin-Kemp will join Renalytix in June as Vice President of Sales, Eastern U.S. Missy will recruit and lead a team of sales representatives focused on supporting primary care physician (PCP) and specialist practices utilizing KidneyIntelX testing as part of health system, government, and payor collaborations. She will also develop the recruiting, training, and management systems for deploying a broader sales team in 2022. Missy brings over 15 years of sales and sales leadership experience to Renalytix, with 10 of those years focused on primary care. Most recently, she served as the Chief Commercial Officer at Fibronostics. Prior to Fibronostics, Missy held multiple sales and business development leadership roles at CardioDx, a pioneer in Cardiovascular genomics. At CardioDx she led efforts to deploy their laboratory tests in private health systems and VA Centers and regional networks (VISNs). She was responsible for successfully driving adoption and revenue growth in primary care practices, including VA Community Care Centers.

Christine Loftsgaarden has joined Renalytix as Vice President of Commercial Partnerships.  Christine will be focused on expanding health system, federal government, and payor collaborations to implement integrated care solutions based on KidneyIntelX risk assessment in early-stage Diabetic Kidney Disease (DKD). Her experience in successful population health-driven implementations and value-based care models will be important to the continued expansion of Renalytix’s solutions in regional health systems and VA centers. Her previous leadership experience includes a focus on clinical delivery and practice optimization at Evolent Health where she improved care delivery through the evaluation, prioritization and development of strategic and innovative value-based care solutions that enable rapid scaling across their market and business model. Christine also worked at DaVita Healthcare Partners where she led high priority clinical innovation projects from concept to operationalization. She also led development and implementation of a comprehensive diabetes management program for DaVita patients.

Stacey Molinari has joined the commercial team as Director of Commercial Partnerships focused on the northeast region. In this role, she will work to expand the Mount Sinai KidneyIntelX program to other regional and government owned health systems. Most recently, Stacey was on the Market Access Account team covering the Great Lakes Region which included New York, Michigan and Indiana at Vifor Pharma, Inc (previously Relypsa). Prior to that, she worked at Abbott Laboratories in roles of increasing responsibility. Stacey has spent the majority of her career working with the chronic kidney disease (CKD) population.

Jon Wisson has joined the Renalytix Managed Care Team as Senior Manager, Government Access. Jon will lead contracting efforts with Veterans Affairs (VA) centers and regional networks (VISNs), military bases and Indian Health Services facilities. He brings over 20 years of experience and success in direct government sales, management and contracting with Cardinal Health, Pharmacia Diagnostics, Terumo Medical, Cooper Genomics and Samsung Neurologica.  Jon’s specialized government sales experience will be a critical enabler for our success in contracting with the VA on both a center and regional (VISN) basis in 2021 and 2022.

Andria Parks-Herrera has joined Renalytix as Vice President of Marketing. Andria will direct Renalytix’s communication efforts across provider, payer and patient stakeholder groups and advance key private and government partnerships focused on education, care delivery and patient engagement to support adoption of KidneyIntelX. Previously Andria led marketing for the Renal Division of OPKO Health, Inc. She also brings knowledge and experience with commercialization in Latin America, important as Renalytix continues to build partnerships that form the foundation for future international expansion.

“The Renalytix technology and market opportunity are attracting a very high caliber of commercial talent,” said Tom McLain, Renalytix President. “This group brings first-hand professional success launching and commercializing innovative solutions in both private and government driven healthcare delivery models. Their contributions will accelerate our expansion into new health systems which in turn will drive adoption and revenue growth in 2022 and 2023.”

 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 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.com (visit www.kidneyintelx.com) which is being designed to help make significant improvements in kidney health through early risk prognosis and optimal clinical care to reduce the incidence of advanced kidney disease and kidney failure. 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 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, our plans for expansion of our business 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 Renalytix

(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

 

Utility Study Indicates KidneyIntelX Risk Assessment can Address Treatment Ambiguity in Primary Care

Clinicians affirm need for accurate early-stage diabetic kidney disease risk assessment to improve patient outcomes and reduce healthcare costs

NEW YORK, June 3, 2021 – Renalytix AI plc (LSE: RENX) (NASDAQ: RNLX) today announced results from a new utility study. The study confirmed the importance of risk assessment testing in addressing treatment ambiguity in the early stages of diabetic kidney disease (DKD) and improving patient engagement and adherence, two major barriers to slowing or preventing DKD progression and preserving kidney health. In clinical studies, KidneyIntelX has shown to accurately predict progression of DKD, suggesting that KidneyIntelX risk assessment could support primary care physicians in making appropriate treatment decisions and slowing or preventing DKD progression.

In this qualitative study involving 16 primary care physicians, 100% of clinician study participants confirmed that early-stage kidney risk assessment, like that provided by KidneyIntelX, will help to address suboptimal therapy, which can lead to rapid progression, increased hospital admissions, emergency room visits, potential kidney failure, need for dialysis, decreased quality of life, and increased costs.

Dr. Joseph Vassalotti, Chief Medical Officer of the National Kidney Foundation (NKF) and Clinical Professor at the Icahn School of Medicine Mount Sinai Health System commented, “The NKF believes primary care physicians have the power to change the outcome for the vast majority of individuals with early-stage kidney disease who are at risk for progressive kidney disease. Americans living with kidney diseases universally express the preference for early diagnosis. This study confirms the compelling data presented at this year’s NKF Spring Clinical Meeting that KidneyIntelX could be widely adopted by primary care physicians (PCPs) and could alter how at-risk populations with type-2 diabetes can receive early education and therapeutic intervention to reduce DKD complications and kidney failure.

 

“At NKF we are fueled with urgency to significantly improve the long-term outcomes that restore full lives for people living with kidney diseases. We encourage PCPs embrace the ability to manage kidney disease risk early to protect their patient’s kidney health.”

In the study, 94% of PCP participants found that kidney disease was difficult to manage in their type 2 diabetes patients. Accurate risk stratification is a critical unmet need and can lead to delays in effective, early interventions.

The study was based on qualitative interviews with sixteen PCPs treating DKD patients. Participating PCPs specialized in internal medicine or family medicine and worked across the major settings of care in the U.S., including private practices, academic medical centers, and integrated delivery networks. Four main themes in DKD were analyzed in the study: Screening Practices; Perceived Knowledge Gaps; Treatment Variability; and the Importance of Risk Stratification. The publication titled, “A Qualitative Study Documenting Unmet Needs in the Management of Diabetic Kidney Disease (DKD) in the Primary Care Setting,” was published in BMC Public Health on May 17, 2021.

 

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, bioprognosticTM 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 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.renalytix.com.

 

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 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.

Media Contacts:

 

United States:

Jennifer Moritz

Zer0 to 5ive for Renalytix

+1 (917) 748-4006

jmoritz@0to5.com

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, CHARLOTTE AND WINSTON-SALEM, N.C., May 19, 2021 — 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.

U.S. General Services Administration Grants 10-Year Governmentwide Contract for RenalytixAI KidneyIntelX Testing

KidneyIntelX Testing Services Available to 140 U.S. Government Departments, Agencies and Affiliates Around the World

NEW YORK, April 22, 2021 — Renalytix AI plc (LSE: RENX) (NASDAQ: RNLX) today announced that the United States Government has granted the company a 10-year Governmentwide Acquisition Contract (GWAC) to provide KidneyIntelX early-stage kidney disease bioprognostic™ testing services. The contract, offered through the General Services Administration (GSA), covers laboratory testing services that can be provided through more than 140 U.S. government departments, agencies and affiliates, including the U.S. Veterans Administration (VA), Department of Defense (DoD) military branches (Army, Navy, Air Force, and Marines), and Indian Health Services (IHS). The contract is effective as of April 15, 2021 and has a five-year term with a five-year extension option, and is structured as an Indefinite Delivery, Indefinite Quantity (IDIQ) contract providing for an unlimited quantity of services over the contract term. Under the contract, KidneyIntelX pricing is set at $950 per reportable result.

With the GSA contract in effect, KidneyIntelX testing is now available through the Federal Supply Schedule. Individual physicians operating within government sponsored healthcare programs can now order KidneyIntelX testing for their patients with diabetic kidney disease. Details about the GSA award and how to order the test can be found here.

The GSA contract simplifies structuring service agreements with VA facilities, military installations, and tribal nations. The contract also facilitates contracting with the VA’s regional healthcare networks (Veterans Integrated Service Networks or VISNs) to cover KidneyIntelX testing for their eligible patients.

The process to be granted a GSA contract can be considered further support for the quality and importance of KidneyIntelX testing. Securing a contract requires an application and rigorous review against specific criteria, including the status of the provider, the quality and dependability of the service provided, and the need for the testing service.

Dr. James Post, Nephrologist and Chief of Internal Medicine at the James J. Peters VA Medical Center in the Bronx, N.Y., commented, “Access to KidneyIntelX testing represents a significant development in the early detection, intervention and management of patients at risk for chronic kidney disease. With the clinical information provided by the KidneyIntelX risk score report, primary care physicians can identify and intervene early in the management of patients who are on a path for renal failure prior to direct involvement of a nephrologist or the need for dialysis.”

“This provides the opportunity for RenalytixAI to support our veterans, active military and Native American communities, and to expand our health system care delivery model,” commented Tom McLain, President at RenalytixAI.  “Achieving this contracting milestone allows us to make KidneyIntelX available to patients throughout the U.S. government healthcare system. Executing on our market access strategy represents a substantial commercial opportunity for RenalytixAI.”

The GSA contract enables RenalytixAI to initiate efforts towards multiple integrated model deployments with government hospital systems. To support these efforts, RenalytixAI has formed a market access team focused on contracting with VA, DoD, and IHS facilities as well as securing coverage agreements with VISNs and the DoD’s TRICARE program to provide broad access to KidneyIntelX testing. TRICARE is the healthcare program for uniformed service members, retirees, and their families. In addition, RenalytixAI plans to expand access to veterans who could benefit from KidneyIntelX testing as part of its health system partnership programs. Several academic medical centers also provide clinical support to VA facilities.

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, bioprognosticTM 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 the General Services Administration Contracting Program
The General Services Administration (GSA) is an independent agency of the United States government established in 1949 to help manage and support the basic functioning of federal agencies. Their responsibilities include the Federal Acquisition Service. The GSA Schedule (also referred to as Multiple Award Schedule (MAS) and Federal Supply Schedule) is a long-term governmentwide contract with commercial firms providing federal, state, and local government buyers access to more than 11 million commercial products and services. GSA contracts fix the rate paid for government work making it much easier to structure individual agency and department contracts. Listing on the Federal Supply Schedule also allows purchases up to defined minimum thresholds without a contract. Laboratory and medical services covered under GSA contracts are generally provided to military veterans, active military, and Native American Tribes. Laboratory services access can also be provided to certain employees of the Federal government including members of the US Senate and US House of Representatives.

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.

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 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.

KidneyIntelX Demonstrates Performance and Informs Treatment Decisions in Multinational CANagliflozin CardioVAScular Assessment Study (CANVAS)

Data from 1,325 CANVAS Participants with Baseline DKD Scored with KidneyIntelX Presented at International Society of Nephrology World Congress of Nephrology 2021

NEW YORK, April 20, 2021Renalytix AI plc (LSE: RENX) (NASDAQ: RNLX) announces the findings of a new study in which the commercially available KidneyIntelX test accurately predicted progression of diabetic kidney disease (DKD) in a multinational cohort from the CANagliflozin CardioVAScular Assessment Study (CANVAS)1 with early-stage DKD (stages 1-3). The clinical outcome data suggests that KidneyIntelX risk assessment could support primary care physicians in making appropriate therapeutic intervention decisions with early-stage DKD patients to effectively delay progression and reduce the risk of adverse events.

Results presented showed comparable risk-stratification with prior validation studies,2 in which participants identified by KidneyIntelX as high risk (15% of the study population, which was comprised of adults with type 2 diabetes and DKD stages 1-3 from 667 centers in 30 countries) had more than an 8-fold higher rate of disease progression compared with those that scored low risk (42% of the population). In contrast, the application of the guideline-recommended KDIGO (Kidney Disease: Improving Global Outcomes) risk classification tool, based on kidney function and urine albumin concentration, only provided a 2.5-fold gradient for DKD progression among study participants identified as high risk compared with those scored as low risk.

This data, presented at the International Society of Nephrology World Congress of Nephrology 2021 (WCN ’21), is the first of a series of outcomes from the analysis of the CANVAS cohort in conjunction with Janssen Research and Development including the role of KidneyIntelX in treatment decisions and monitoring therapeutic effect.

“KidneyIntelX performed very well in a multinational cohort of individuals with type 2 diabetes and early-stage DKD,” said Dr. David W. Lam, MD, Medical Director Mount Sinai Clinical Diabetes Institute and first author on the presentation. “The new data from CANVAS supports primary care physicians using the KidneyIntelX score to risk stratify and make informed care decisions with their patients. The results also advance the concept that there is most to be gained from early-stage intervention and the protective effects of SGLT2i on kidney function decline in those that score as highest risk for progression with KidneyIntelX.”

Access to the CANVAS trial cohort, which compared the SGLT2i inhibitor canagliflozin versus a placebo, and collected blood samples in most participants, supported that baseline risk stratification with KidneyIntelX identified individuals most likely to benefit from canagliflozin vs. placebo. Canagliflozin is FDA approved to reduce the risk for end-stage renal disease, worsening of kidney function, cardiovascular death, and hospitalization for heart failure among adults with type 2 diabetes and DKD. Data presented also showed that there was a 3-fold greater magnitude in the protective effect of canagliflozin on longitudinal eGFR slope (a measure of kidney function and cardiovascular risk) for study participants at high baseline risk who received SGLT2i therapy compared with those who scored as low risk.

The data was shared in a poster presentation titled “Clinical Utility of KidneyIntelX in Patients with Early Stages of Diabetic Kidney Disease in CANVAS Participants.” The poster can be found through the KidneyIntelX site and the study abstract is available through Kidney International Reports.

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.3 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, bioprognosticTM 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

Sources

  1. Canagliflozin and Cardiovascular and Renal Events in Type 2 Diabetes | NEJM
  2. https://link.springer.com/article/10.1007/s00125-021-05444-0
  3. 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 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.

Clinical Utility Study Demonstrates Primary Care Physicians Highly Likely to Order KidneyIntelX to Inform Care Decisions

Value of KidneyIntelX Testing Demonstrated by Data from 401 Physician Study Presented at National Kidney Foundation 2021 Spring Clinical Meetings

NEW YORK, April 8, 2021Renalytix AI plc (LSE: RENX) (NASDAQ: RNLX) announces findings presented in a Late-Breaking presentation at the National Kidney Foundation’s 2021 Spring Clinical Meetings (NKF SCM21) titled Clinical Utility of a New Prognostic Test to Predict the Risk of Kidney Function Decline in Diabetic Kidney Disease Patients. Results support that KidneyIntelX may be widely adopted by primary care physicians (PCPs) and that the easy-to-understand risk score and recommended care path on the report could help improve care for patients at high risk for progressive kidney function decline or failure. The findings from this study are significant for clinicians, health systems, payers and patients in understanding the value of KidneyIntelX testing in large scale adult diabetic kidney disease (DKD) populations.

“Clear and objective utility evidence like these results presented at the NKF Spring Clinical Meeting this week are critical for evaluating the value of innovative new approaches for CKD assessment,” said Elizabeth Montgomery, Vice-President, Learning Strategies and Primary Care Programs at the National Kidney Foundation. “This is important evidence for clinicians, decision-makers and payers as it illustrates the benefits of focusing on preserving kidney health in the earliest stages of the disease when new therapeutics, patient engagement and specialist referral have the potential to delay or prevent progression. The results of the study involving 401 primary care physicians show what can be possible for improving outcomes and quality of life for patients who otherwise are likely to progress to end-stage kidney disease, dialysis or transplant,” commented Ms. Montgomery.

In the study, 98% of PCPs would order testing if reimbursement was established, the FDA had provided clearance, and it was commercially available. Additionally, the KidneyIntelX risk score was consistently ranked as very important in their overall clinical decision-making process. The study included 401 board-certified PCPs from across the U.S. practicing across different care settings and payer models who care for DKD patients today. These clinicians reviewed written patient profiles including key clinical attributes for evaluating DKD and determining the best care plan for their patients. When a KidneyIntelX result was available, the study PCPs were approximately 1.5 times more likely to appropriately prescribe SGLT2 inhibitors (SGLT2i) and angiotensin II receptor blockers (ARB) for their high-risk patients. They were also nearly 2.5 times more likely to appropriately refer their high-risk patients to a specialist. These findings confirm that KidneyIntelX provides actionable information for understanding a patient’s risk of progression in early-stage kidney disease, through which it can inform actions to delay or prevent progression when kidney function is at levels that support a normal life. More timely and appropriate treatment decisions should ultimately improve outcomes and lead to decreased health-care costs.

“We know there is under-utilization of proven therapies in patients with early stage DKD, particularly regarding ARBs to control blood pressure and SGLT2 inhibitors to manage diabetes,” stated Steve Coca, MD, Co-Founder of RenalytixAI. “This study suggests that the assessment of future risk for kidney disease progression based on KidneyIntelX scoring can potentially overcome the inertia towards application of medical therapies and patient-directed care plans in early stages of their disease when intervention can have the greatest benefit for preserving kidney heath and quality of life. Further evidence assessing the value KidneyIntelX will be generated in prospective utility studies that we are currently conducting. This significant body of real-world evidence data is being designed to serve as a model for informing clinical teams and health systems on how to maintain kidney health and improve outcomes while reducing the burden of kidney failure in these at-risk populations.”

The study was conducted by Boston Healthcare Associates, a global strategy consulting firm that advises clients on how to optimize innovation value in a complex clinical and economic environment that transforms patient care and significantly improve health outcomes, with funding from RenalytixAI. Interested parties can now find an abstract on the study in the NKF SCM21 2021 Abstract and E-Poster Gallery here.

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, bioprognosticTM 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

 

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 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 physician acceptance, 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.

Multi-Center Study Finds KidneyIntelX 72% More Effective Than Current Standard of Care In Identifying Early-Stage Patients at High Risk for Kidney Disease Progression and Failure

Clinical findings published in the April issue of Diabetologia, the official journal of the European Association for the Study of Diabetes

NEW YORK, Apr 5, 2021

RenalytixAI plc (LSE: RENX) (NASDAQ: RNLX), announced today that KidneyIntelX™ more accurately predicted progressive kidney function decline and kidney failure in a multi-center, diverse cohort of 1,146 type 2 diabetes patients with early-stage (stages 1, 2, and 3) kidney disease versus the current standard of care. The results of the study, which is the second peer-reviewed clinical validation study on KidneyIntelX, have been published in Diabetologia, the official journal of the European Association for the Study of Diabetes (EASD).

Strong performance of the KidneyIntelX platform is attributed in part to its proprietary, blood-based biomarker technologies, exclusively licensed from the Joslin Diabetes Center and the Mount Sinai Health System.

Notably, KidneyIntelX was observed to be highly effective at both ends of the risk spectrum. In the study, KidneyIntelX more accurately identified and segmented patients into three risk categories (low, intermediate and high) when compared to clinical models, including the current standard of care, the KDIGO risk stratification algorithm. When guideline-recommended urine albumin to creatinine ratio testing was performed, the positive predictive value (PPV) for progressive decline in kidney function was 69% for those scored as high-risk by KidneyIntelX versus the 40% identified as highest-risk by KDIGO categorization. This is a 72% improvement compared to standard of care. In addition, only 7% of those scored as low-risk by KidneyIntelX experienced progression (i.e., negative predictive value of 93%).

“Diabetes is one of the leading causes of kidney failure in the United States. Appropriate treatment for kidney disease is a significant challenge in type 2 diabetes patients,” said Dr. Marina Basina, Clinical Professor, Medicine – Endocrinology, Gerontology, & Metabolism, Stanford Medicine and Medical Director of Inpatient Diabetes, Stanford Health Care. “Data from the KidneyIntelX risk assessment platform could significantly improve the care path for diabetes patients and delay the severe consequences of diabetic kidney disease. Identifying the risk for kidney disease complications in diabetic patients in the earlier stages of the disease is essential to improving kidney health and reducing health care costs.”

Accurate segmentation of patient groups based on risk will yield benefits from targeted clinical care plans. High-risk patients identified earlier in the disease cycle can be prioritized to receive precision medicine and optimized care management to slow or arrest progressive kidney disease, while low-risk patients can avoid unnecessary treatments, follow-up visits and anxiety. KidneyIntelX has the potential to uniquely inform health care providers, insurance payors and population health managers about the expected rate of progression and risk of failure in early-stage kidney disease patients. KidneyIntelX is expected to support optimization of care delivery, improve patient outcomes and reduce the $120 billion annual cost of kidney disease to the United States Medicare system.1

“Given these additional clinical study findings, we are confident that KidneyIntelX will be adopted as part of the standard of care in assessing the risk of progressive kidney decline in individuals with early-stage diabetic kidney disease,” said Michael J. Donovan, MD, Ph.D., Chief Medical Officer, RenalytixAI. “These results published in Diabetologia further validate our rigorous scientific and clinical approach, which is focused on early detection and aggressive clinical intervention for those found to be at the highest risk.”

The Diabetologia article entitled, “Derivation and validation of a machine learning risk score using biomarker and electronic patient data to predict progression of diabetic kidney disease,” is available at https://link.springer.com/article/10.1007/s00125-021-05444-0.

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

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 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.

 

The University of Utah and RenalytixAI Partner to Drive Innovation in Kidney Health

Innovative partnership to enable health system-wide approach to help delay or prevent progression in the earliest stages while advancing genetics research for detection, prognosis and treatment of chronic kidney disease

NEW YORK, Feb. 24, 2021 — Renalytix AI plc (LSE: RENX) (NASDAQ: RNLX), an artificial intelligence-enabled in vitro diagnostics company, and the University of Utah, one of the top research institutions in the United States, today announced a partnership to improve kidney health and reduce the risk of kidney failure for large scale populations in the earliest stages of kidney disease.

The partnership intends to implement RenalytixAI’s in vitro diagnostic platform, KidneyIntelX, in combination with a range of advanced clinical management solutions to optimize patient care and drive towards improved outcomes system-wide at University of Utah Health, which serves millions of patients in six states. KidneyIntelX is designed for the identification of adults with early-stage chronic kidney disease and diabetes who are at risk for progressive kidney function decline or kidney failure.

Core to this partnership is the implementation of care navigation and pharmacy programs, behavioral and health economic assessments, together with data-driven analytics. KidneyIntelX will be deployed directly into the electronic health records (EHR) system at University of Utah Health, enabling access to more than 1,700 clinicians for seamless test ordering and patient risk score reporting as part of the standard clinical workflow.

The RenalytixAI and University of Utah partnership was facilitated by the University’s designated office for industry relations, The Partners for Innovation, Ventures, Outreach & Technology (PIVOT) Center.

“Working with RenalytixAI to improve kidney disease management yields the University of Utah new avenues to innovate approaches to translational research, health informatics, and clinical care,” said John Inadomi, chair of the Department of Internal Medicine, University of Utah School of Medicine. “This partnership is exciting because it is so forward looking. It also demonstrates the value of having a resource like the PIVOT Center which is able to drive complicated relations for our exceptional health enterprise.”

“RenalytixAI is a unique and ideal partner to engage in a multi-dimensional collaboration like this, in real-time and at scale,” said Keith Marmer, chief innovation and economic engagement officer, University of Utah. “The University of Utah’s PIVOT Center is focused on catalyzing the innovation ecosystem in Utah by integrating technology commercialization, economic development and corporate engagement, and this partnership with RenalytixAI serves as a terrific example of how we’ve come together to do just that.”

“University of Utah’s clinical and translational expertise presents an ideal opportunity to interrupt the devastating and costly effects of progressive chronic kidney disease from its earliest stages to help prevent irreversible late-stage kidney disease and dialysis,” said James McCullough, chief executive officer, RenalytixAI. “This partnership is enabling RenalytixAI to address a major health problem, help build the life sciences sector in Utah and show the economic value of such a robust public private collaboration. We look forward to being able to announce additional innovative partnerships of this type in the near future.”

Integral to the partnership, RenalytixAI and the University of Utah are supporting continued research and development in: 1) understanding kidney disease progression and improving clinical management in underserved minority communities;  2) novel care delivery and treatment models in early-stage chronic kidney disease (CKD) across all populations; and 3) identifying genetic biomarkers for incorporation into KidneyIntelX and other machine learning-driven algorithms to enhance diagnosis, prognosis, and monitoring of patients in the earliest disease stages. RenalytixAI will be providing financial support to the University of Utah over a five-year period in the form of sponsored research, software and education program development, and third-party resources in each of these critical areas.

“The growing partnership between RenalytixAI and the University of Utah is an ideal example of the great innovation possible within Utah’s rich life sciences ecosystem,” said Katelin Roberts, interim director of BioHive, a thriving collective of more than 1,100 companies representing the life science and healthcare innovation ecosystem of Utah’s economy. “The entrepreneurial, can-do spirit of the partners, coupled with unique technology and research capacities, will potentially enable new advances in patient care and disease management throughout the state.”

This partnership follows RenalytixAI’s establishment of a new commercial laboratory in the University of Utah’s Research Park in 2020 and demonstrates the continued growth of RenalytixAI’s operations for the western United States. RenalytixAI intends to rapidly expand employees and infrastructure in the state and accelerate the availability of advanced precision medicine diagnostics for Utah diabetes and kidney disease patients.

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 the Partners for Innovation, Ventures, Outreach & Technology (PIVOT) Center

The Partners for Innovation, Ventures, Outreach & Technology (PIVOT) Center leads the University of Utah’s centralized and integrated strategy and operation for technology commercialization, corporate engagement, and economic development. In doing so, PIVOT Center serves as a hub for the U to foster partnerships between industry, university, and government entities. The center formalizes the U’s commitment to broaden its impact on Utah’s economy by enhancing local and global collaborations to catalyze innovation. The center’s mission is to generate economic returns for the university and the state of Utah, expand the university’s reputation for innovation, and positively impact society. The University of Utah was recently ranked 2nd among large research universities for “innovation productivity impact.”

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.com (visit www.kidneyintelx.com) which is being designed to help make significant improvements in kidney health through early risk prognosis and optimal clinical care to reduce the incidence of advanced kidney disease and kidney failure.  For more information, visit www.renalytixai.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 commercial prospects of KidneyIntelX, the success of our partnership with the University of Utah, our ability to enter into and maintain agreements with laboratory service providers and logistics providers across multiple territories in the United States to ensure secure and efficient delivery of patient samples to our laboratories, and the ability of KidneyIntelX to curtail costs of CKD and end-stage kidney disease 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, 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.

American Society of Nephrology and Renalytix to Co-Host Virtual Capital Markets Day for Kidney Health

Event Featuring Leading Clinicians, Biotech Innovators and Federal Health Agencies to Highlight Innovation and Opportunity in Kidney Health

 

NEW YORK, Feb. 4, 2021Renalytix AI plc (LSE: RENX) (NASDAQ: RNLX), an artificial intelligence-enabled in vitro diagnostics company, focused on optimizing clinical management of kidney diseases to drive improved patient outcomes and advance value-based care, announced today that it will co-host a Capital Markets Day for Kidney Health with the American Society of Nephrology (ASN) on Thursday, February 11 from 8:00 a.m. —  12:30 p.m. EST. The virtual event will bring together a broad group of delegates representing the kidney community, including leading clinicians, representatives of U.S. government health agencies, kidney care innovators and investors focused on life sciences and medical technology, for a series of presentations and panel discussions on the challenges and innovations arising from kidney health and the market opportunity in this area.

 

The Capital Markets Day for Kidney Health event will feature keynote addresses by Susan E. Quaggin, MD, FRCP(C), FASN, President, American Society of Nephrology and Chief, Division of Nephrology and Hypertension, Director, Feingberg Cardiovascular and Renal Research Institute, Charles Horace Mayo Professor of Medicine at Northwestern University; and Steven Coca, DO, MS, Associate Professor of Medicine Icahn School of Medicine at Mount Sinai, New York and co-founder of RenalytixAI. RenalytixAI CEO James McCullough will also participate in a panel discussion on lead IPOs in kidney disease in 2020.

 

The full agenda and registration information can be viewed here: https://www.asn-online.org/KCMD

 

Kidney diseases affects 850 million individuals worldwide, including over 37 million Americans, costing the U.S. healthcare system over $120 billion per year in Medicare spending alone.1, 2, 3 Despite the significant patient need, awareness and new product development has lagged behind many other fields, until now. There is a trend among healthcare companies, medical providers, organizations, and researchers to assess early-stage prognosis and end-to-end integrated solutions for kidney disease in an effort to prevent the economic and health impacts.

 

“Better management in kidney disease is happening now, and the roster of speakers today are innovators in their field and at the cutting edge of transforming the way we understand the progression of early-to-end-stage kidney disease,” said Susan E. Quaggin, MD. “As we begin to change the consequences of kidney disease for patients through the use of emerging technologies, we expect to begin to see better outcomes for patients as well as benefits in the health system.”

 

“Kidney disease is one of the biggest unmet public health needs today. New advancements in precision medicine coupled with significant recent changes in reimbursement and regulatory policies have made kidney disease one of the most attractive areas for innovation and investment in the healthcare space,” said James McCullough, CEO of RenalytixAI.

 

The list of speakers participating in the Capital Markets Day for Kidney Health includes:

  • Amy P. Abernathy, MD, PhD, US Food and Drug Administration
  • Daniel Arias, Stifel Financial Corp.
  • Randy Baron, Pinnacle Associates
  • Sara Barrington, Verici DX Limited
  • Steven G. Coca, DO, MS, Icahn School of Medicine at Mount Sinai, Co-Founder, RenalytixAI
  • Jennifer Erickson, Former White House Office of Science and Technology Policy, Obama Administration
  • Tod Ibrahim, American Society of Nephrology
  • Alan S. Kliger, MD, Yale University School of Medicine
  • Leslie Trigg, Outset Medical, Inc.
  • Kevin Longino, National Kidney Foundation
  • Rachel N. Meyer, American Society of Nephrology
  • James McCullough, RenalytixAI
  • Susan E. Quaggin, MD, FASN, American Society of Nephrology, Northwestern University
  • Anne Rohall-Andrade, Living Kidney Donor, Former HHS Office of Assistant Secretary for Health, Trump Administration
  • Prabir Roy-Chaudhury, MD, PhD, FRCP, University of North Carolina, Chapel Hill, American Society of Nephrology
  • Jeffrey Shuren, MD, JD, US Food and Drug Administration
  • Boris Vuchic, Crescent Rock Capital

 

This event is intended for investors only. Media interested in more information can contact jmoritz@0to5.com.

 

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 the American Society of Nephrology

Since 1966, ASN has been leading the fight to prevent, treat, and cure kidney diseases throughout the world by educating health professionals and scientists, advancing research and innovation, communicating new knowledge, and advocating for the highest quality care for patients. ASN has more than 20,000 members representing 131 countries. For more information, please visit www.asn-online.org or contact the society at 202-640-4660.

 

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.com (visit www.kidneyintelx.com) 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. For more information, visit www.renalytixai.com

 

Sources

1 American Society of Nephrology

2 Centers for Disease Control and Prevention

3 United States Renal Data System

 

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 ability of technological and other advancements to curtail costs of CKD and end-stage kidney disease 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 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.

https://www.asn-online.org/g/blast/files/KCMD_2021_Program.pdf