Renalytix Plc Regulatory News (RENX)

Renalytix plc

("Renalytix" or the "Company")

Renalytix selects EVERSANA® to expand commercialization of KidneyIntelX for Early-Stage Kidney Disease Prognosis Detection in Patients with Type 2 Diabetes

Model expected to accelerate deployment of KidneyIntelX across key U.S. regions with high rates of diabetic kidney disease and established insurance coverage

LONDON and CHICAGO (May 25, 2023) - Renalytix (NASDAQ: RNLX) (LSE: RENX), the first company to develop and commercialize an artificial intelligence (AI) powered in-vitro diagnostic for kidney disease, has selected EVERSANA, a global leader in life-science commercialization services, to expand the company's commercial footprint for KidneyIntelX, a prognostic device for patients with diabetic kidney disease. Using highly reliable, bioprognostic™ methodology, KidneyIntelX yields a simple-to-understand, custom risk score, helping clinicians better predict which adult patients with type 2 diabetes may be at various stages of chronic kidney disease.

"We believe that patients deserve the best options every day in their healthcare journey," said Jim Lang, CEO at EVERSANA. "What Renalytix has created has the potential to impact millions of lives through early-stage preventative care, which will not only make a huge impact on the global healthcare system but most importantly, improve the lives of patients. We could not be more excited to provide our services to support a successful commercialization."

EVERSANA will launch its field deployment and training solutions with Renalytix to primary care providers across key parts of the United States later this summer. These EVERSANA-supported deployments complement Renalytix existing sales efforts in major markets including New York and Illinois where comprehensive insurance coverage is now available for individuals living with diabetes and kidney disease. 

"The majority of people with type 2 diabetes over the age of 65 have chronic kidney disease," said James McCullough, CEO of Renalytix. "EVERSANA will help us bring the benefits of KidneyIntelX early prognosis quickly to large populations at greatest risk to help prevent the unnecessary suffering and unsustainable cost of kidney failure and dialysis."

Two large clinical utility studies published in the Journal of Primary Care and Community Health, and American Journal of Managed Care, have shown KidneyIntelX assists clinicians to better understand patients at low, intermediate, or high risk for kidney disease progression and kidney failure resulting in improved use of guideline-based medications and timely specialist referrals for patients with type 2 diabetes and chronic kidney disease. Further, recently published emerging data indicates use of KidneyIntelX by primary care providers results in an improvement in kidney and diabetes clinical metrics such as HbA1C and UACR (albumin to creatinine ratio). Additional real-world KidneyIntelX utility data is expected to be released at the American Diabetes Association annual clinical meeting this June.

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About EVERSANA®

EVERSANA® is the leading independent provider of global services to the life sciences industry. The company's integrated solutions are rooted in the patient experience and span all stages of the product life cycle to deliver long-term, sustainable value for patients, prescribers, channel partners and payers. The company serves more than 670 organizations, including innovative start-ups and established pharmaceutical companies, to advance life sciences solutions for a healthier world. To learn more about EVERSANA, visit eversana.com or connect through LinkedIn and Twitter.

About Renalytix

Renalytix (NASDAQ: RNLX) (LSE: RENX) is an in-vitro diagnostics and laboratory services company that is the global founder and leader in the new field of bioprognosis™ for kidney health. The leadership team, with a combined 200+ years of healthcare and in-vitro diagnostic experience, has designed its KidneyIntelX laboratory developed test to enable risk assessment for rapid progressive decline in kidney function in adult patients with T2D and early CKD (stages 1-3). We believe that by understanding how disease will progress, patients and providers can take action early to improve outcomes and reduce overall health system costs. For more information, visit www.renalytix.com.

About KidneyIntelX™

KidneyIntelX™ is a laboratory developed test demonstrated to be a reliable, bioprognostic™ methodology that yields a simple-to-understand, custom risk score, enabling prediction of which adult patients with T2D and early CKD (stages 1-3) are at low, intermediate or high risk for rapid progressive decline in kidney function. By combining information from KidneyIntelX with newer cardio- and reno-protective therapies, doctors will have more information in determining which patients are at higher versus lower risk for rapid disease progression and may be able to more appropriately target resources and guideline-recommended treatments to advance kidney health. KidneyIntelX is supported by a growing body of clinical, utility and health economic studies (including a validation study of two large cohorts) and has a demonstrated a 72% improvement in predicting those patients who are at high risk for rapid progressive decline in kidney function versus the current standard of care (eGFR and UACR). KidneyIntelX has received Breakthrough Device Designation from the U.S. Food and Drug Administration and Renalytix has submitted for De Novo marketing authorization. To learn more about KidneyIntelX and review the evidence, visit www.kidneyintelx.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 KidneyIntelX, the expected benefits of the transaction with EVERSANA, the anticipated timing of EVERSANA's launch of its field deployment and training solutions, the potential for KidneyIntelX to receive regulatory approval from the FDA, the commercial prospects of KidneyIntelX, if approved, including whether and to what extent KidneyIntelX will be successfully adopted by physicians and distributed and marketed, our expectations regarding the ability of KidneyIntelX to curtail costs of chronic and end-stage kidney disease, optimize care delivery, address systemic inequalities 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 31, 2022, 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.