Clinical utility study data: further highlights
("Renalytix" or the "Company")
Primary Care Use of KidneyIntelX in Early Stage CKD
Improved Clinical Care Delivery and Outcomes
First-in-class bioprognostic™ KidneyIntelX provided clear direction for primary care physicians to slow or stop progression of chronic kidney disease in adult diabetes patients
Kidney disease in the US often goes untreated in the primary care setting, contributing to the more than 50,000 individuals per year with diabetes and chronic kidney disease (CKD)
This study data is especially meaningful for overburdened clinical teams in the primary care community
Slowing the progression of diabetic kidney disease is also important to health systems and payers. Medicare alone spends an estimated
The key highlights from this real-world evidence study publication include:
· 57% of high risk patients had action taken (medication change or referral) within 3-months, compared to 35% for low risk patients. Medication changes included introducing SGLT2 inhibitors to manage type 2 diabetes and CKD as well as adjustments for ACEi/ARBs to manage hypertension.
· Notably clinical observations from the study showed a nearly 10% improvement in HbA1c levels in the high risk group in the first six months. This improvement type 2 diabetes management is most likely the result of both increased patient engagement combined with appropriate medication changes including the introduction of SGLT2 inhibitors.
· While other metrics such as eGFR and systolic blood pressure (SBP) remained unchanged at the 6-month data mark, there was a 15% improvement in albuminuria, an important indicator of overall kidney health, in the low and intermediate risk groups.
This evidence builds on a previously published study in the
According to
"These groundbreaking results demonstrate that we have the opportunity to make a tangible difference today in two of the most complex chronic disease conditions that the
For further information, please contact:
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Via Walbrook PR |
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Stifel (Nominated Adviser, Joint Broker) |
Tel: 020 7710 7600 |
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Tel: 020 7597 4000 |
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Tel: 020 7933 8780 or renalytix@walbrookpr.com |
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Mob: 07980 541 893 / 07407 804 654 |
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CapComm Partners |
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Tel: 415-389-6400 or investors@renalytix.com |
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About Kidney Disease
Kidney disease is a public health epidemic affecting over 850 million people globally.1
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
Sources
1 https://www.theisn.org/blog/2020/11/27/more-than-850-million-worldwide-have-some-form-of-kidney-disease-help-raise-awareness/
2 https://www.cdc.gov/kidneydisease/publications-resources/ckd-national-facts.html
3 https://www.cdc.gov/kidneydisease/basics.html
Forward Looking Statements
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Examples of these forward-looking statements include statements concerning: the potential benefits, including economic savings, of KidneyIntelX, the future impact of KidneyIntelX on clinical decision-making and outcomes, 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 reimbursement decisions and the ability of KidneyIntelX to curtail costs of chronic and end-stage kidney disease, optimize care delivery, address systemic inequalities and improve patient outcomes. The results presented in this press release are interim results; subsequent interim results and full results may vary and may not be consistent with these interim results. 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
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