Submission seeking FDA Clearance of KidneyIntelX
("RenalytixAI", the "Company")
RenalytixAI Files Submission Seeking
KidneyIntelX is designed to provide potentially critical new information to health care providers, insurance payors and population health managers in an effort to support optimization of care delivery, improve patient outcomes and reduce the
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Performance data provided by RenalytixAI in the FDA 510(k) submission is based on a multi-center validation study of more than 1,100 patients demonstrating that KidneyIntelX accurately identifies patients in early CKD stages 1, 2 and 3 who are at highest risk of progressive decline in kidney function and/or kidney failure.
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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N+1 Singer (Joint Broker) |
Tel: 020 7496 3000 |
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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
* https://www.cdc.gov/kidneydisease/publications-resources/2019-national-facts.html
About RenalytixAI
RenalytixAI 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. RenalytixAI's products are being designed to make significant improvements in kidney disease diagnosis, clinical care, patient stratification for drug clinical trials and drug target discovery. For more information, visit www.renalytixai.com.
Sources
1 United States Renal Data System: https://www.usrds.org/media/2371/2019-executive-summary.pdf
2 https://pubmed.ncbi.nlm.nih.gov/29054846/
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: our ability to achieve regulatory clearance of KidneyIntelX from the FDA 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 not yet 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
Media Contacts:
Zer0 to 5ive for RenalytixAI
(484) 574-1855
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