VP of Global Quality and Regulatory Appointment
("Renalytix" or the "Company")
Renalytix Appoints Joseph Hutson Vice President of Global Quality and Regulatory
Hutson To Build-on Renalytix Quality and Regulatory Strategy for KidneyIntelX Global Commercialization
The KidneyIntelX commercial program is being designed to CLIA, CAP, ISO, FDA, and In Vitro Diagnostics Regulation (IVDR) regulations and international standards which will support global market access for current and future KidneyIntelX innovative products and services. KidneyIntelX is currently under FDA review for De Novo marketing authorization under Breakthrough Device designation. Hutson will contribute his knowledge and expertise to the efficient FDA review of this submission.
"The dynamic quality and regulatory environments in
Most recently, at
For further information, please contact:
Renalytix plc |
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Via Walbrook PR |
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Stifel (Nominated Adviser, Joint Broker) |
Tel: 020 7710 7600 |
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Investec Bank plc (Joint Broker) |
Tel: 020 7597 4000 |
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Walbrook PR Limited |
Tel: 020 7933 8780 or renalytix@walbrookpr.com |
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Mob: 07980 541 893 / 07584 391 303 |
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About Kidney Disease
Kidney disease is now recognized as a public health epidemic affecting over 850 million people globally. The
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
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
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, our global market access strategy for KidneyIntelX, 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
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