Renalytix Plc Regulatory News (RENX)

Renalytix plc

("Renalytix" or the "Company")

Renalytix Launches myIntelX, Providing National Physician Access to KidneyIntelX Testing Platform

myIntelX will be launching in conjunction with KidneyIntelX going live at Atrium Health, and will expand testing services across all Renalytix healthcare provider partners

NEW YORK, NY and SALT LAKE CITY, UT March 9, 2022 - Renalytix plc (NASDAQ: RNLX) (LSE: RENX) today announced the launch of its new provider access portal, myIntelX, which will provide nationwide online access for physicians to order KidneyIntelX bioprognosticTM testing for more accurate identification of patients at greatest risk for rapid progression of kidney disease in type 2 diabetes patients. The Renalytix myIntelX portal is being launched in conjunction with the launch of KidneyIntelX testing within Atrium Health, which previously announced a collaboration with Renalytix in May 2021. Providers nationally can access myIntelX at https://myIntelX.com.

The myIntelX portal can streamline ordering and reporting for current testing locations across the country, including CDPHP health plans in New York State and testing in the Veterans Health Administration (VHA) in Florida (VISN 8). As part of the regional and VHA expansion for KidneyIntelX, testing is currently live in Mount Sinai Health System in New York and Wake Forest in North Carolina, and is expected to be implemented within St. Joseph's in New York, Singing River Health System in Mississippi, University of Utah in Utah and several additional VHA centers across the country before the end of June 2022.

"Virtual capability provided through our myIntelX portal is an important step towards expanding access nationally to the KidneyIntelX proprietary technology," said Tom McLain, President, Renalytix. "myIntelX now makes simple, early-stage risk assessment available online for practices that might not otherwise have access to KidneyIntelX integrated ordering through our large-scale health system partnerships."

"There are over 37 million Americans with chronic kidney disease, which can be largely treatable or event preventable, but only when identified and intervened within its early stages," said Michael J. Donovan, PhD, MD, Chief Medical Officer at Renalytix. "The quality of primary care for patients with chronic kidney disease is impacted by patient volume, co-morbidities, geography, and socioeconomic disparities. Providing a mechanism that facilitates patient identification, access and monitoring is the first step towards improving overall care."

The launch version of the myIntelX portal supports the secure and efficient execution of both test ordering and report delivery of KidneyIntelX. The portal has been designed for scalability using cutting edge platform technology for optimal user experience. Additional features to support provider and patient education and engagement will follow as part of providing the comprehensive, fully integrated KidneyIntelX platform. After a provider registers with myIntelX online, Renalytix will enable training and support through its commercial salesforce and client service professionals to implement and sustain KidneyIntelX testing in independent practices. Renalytix will continue to process all tests through its clinical laboratories, which are built to the most rigorous standards: CLIA certified, ISO certified, CAP accredited and U.S. Food and Drug Administration (FDA) compliant.

KidneyIntelX is the only kidney health platform that has received Breakthrough Device Designation from the FDA. KidneyIntelX has secured provider agreements with more than 30 state Medicaid programs and is also covered under various commercial insurance programs.

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About Kidney Disease

Kidney disease is now recognized as a public health epidemic affecting over 850 million people globally. The Centers for Disease Control and Prevention (CDC) estimates that 15% of US adults, or 37 million people, currently have chronic kidney disease (CKD). Further, the CDC reports that 9 out of 10 adults with CKD do not know they have it and one out of two people with very low kidney function who are not on dialysis do not know they have CKD.1 Kidney disease is referred to as a "silent killer" because it often has no symptoms and can go undetected until a very advanced stage. Each year kidney disease kills more people than breast and prostate cancer.2 Every day, 13 patients in the United States die while waiting for a kidney transplant.3

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 disease (DKD) progression risk assessment by combining diverse data inputs, including validated blood-based biomarkers and personalized data from the patient's health record, and employs a proprietary algorithm to generate a unique patient risk score. This patient risk score enables prediction of progressive kidney function decline in DKD, allowing physicians and healthcare systems to optimize the allocation of treatments and clinical resources to patients at highest risk.

Sources

1https://www.cdc.gov/kidneydisease/publications-resources/ckd-national-facts.html2://www.nicresearch.com/clinical-research-necessary-nephrology/3 https://optn.transplant.hrsa.gov/   

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, the expected benefits of the myIntelX platform, including potential effects on test volume and access, 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.