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NEW YORK, March 04, 2021 (GLOBE NEWSWIRE) — Renalytix AI plc (LSE: RENX) (NASDAQ: RNLX), an artificial intelligence-enabled in vitro diagnostics company, focused on optimizing clinical management of kidney disease to drive improved patient outcomes and advance value-based care, announces that under the Company’s Employee Share Purchase Plan (“the ESPP”), new 17,652 ordinary shares of £0.0025 each in the capital of the Company (“the Ordinary Shares”) have been issued to settle the purchase of 8,826 American Depositary Shares, each representing two Ordinary Shares (“ADSs”) by employees who participated in the ESPP. Further details in relation to the ESPP were contained in the Company’s announcement of 2 September 2020.

O. James Sterling, Chief Financial Officer, participated in the plan and acquired 4,596 ordinary shares (2,298 ADSs) at £4.50 per share ($12.563 per ADS).

The purchase of ADSs by certain employees of the Company who are treated as affiliates under U.S. securities laws (including O. James Sterling, Chief Financial Officer) will be settled once certain additional U.S. securities law requirements have been complied with.

An application will be made to the London Stock Exchange for the new Ordinary Shares to be admitted to trading on AIM. It is expected that admission of the 17,652 new Ordinary Shares to trading on AIM will become effective on, or around, 9 March 2021 (“Admission”).

Total voting rights
Following Admission, the Company will have 72,047,286 Ordinary Shares in issue with each share carrying the right to one vote. The Company has no Ordinary Shares held in treasury. The total number of voting rights in the Company following Admission will therefore be 72,047,286.

For further information, please contact:

About Kidney Disease 
Kidney disease is now recognised 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 1 out of 2 people with very low kidney function who are not on dialysis do not know they have CKD*. 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 the United States die while waiting for a kidney transplant.

* https://www.cdc.gov/kidneydisease/publications-resources/2019-national-facts.html

About RenalytixAI
RenalytixAI is a developer of clinical grade, artificial intelligence-enabled in vitro diagnostic solutions for kidney disease, one of the most common and costly chronic medical conditions globally. The Company’s products are being designed to make significant improvements in kidney disease diagnosis, transplant management, clinical care, and patient stratification for drug clinical trials. For more information, visit renalytixai.com

Notification of dealings in shares by PDMRs of the Company:

Published on : http://www.globenewswire.com/news-release/2021/03/04/2187485/0/en/Renalytix-AI-plc-Issue-of-Shares-Under-the-2020-Employee-Share-Purchase-Plan-PDMR-Dealing-and-Total-Voting-Rights.html

NEW YORK, Feb. 22, 2021 (GLOBE NEWSWIRE) — Renalytix AI plc (LSE: RENX) (NASDAQ: RNLX) (“RenalytixAI” or the “Company”), the artificial intelligence-enabled in vitro diagnostics company, focused on optimizing clinical management of kidney disease to drive improved patient outcomes and advance value-based care, announces that it will report its financial results for the six and three months ended December 31, 2020 on Tuesday, March 2, 2021.

Analyst conference call

The Company will hold an analyst conference call at 8:30 a.m. (EST) / 1:30 p.m. (GMT) p.m. on Tuesday, March 2, 2021. James McCullough, CEO and O. James Sterling, CFO will discuss the financial results and provide a corporate update.

Conference Call Details
US/CANADA Participant Toll-Free Dial-In Number: (833) 614-1551
US/CANADA Participant International Dial-In Number: (914) 987-7290
United Kingdom Dial-In Number: 08000 288 438
United Kingdom, London Dial-In Number: 020 3107 0289
Conference ID: 8982902

Webcast Registration link: https://edge.media-server.com/mmc/p/vmhxbo58

For further information, please contact:

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 1 out of 2 people with very low kidney function who are not on dialysis do not know they have CKD*. 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 the United States die while waiting for a kidney transplant.
* 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, transplant management, clinical care, patient stratification for drug clinical trials, and drug target discovery. For more information, visit www.renalytixai.com.

Forward Looking Statements

This press release contains forward-looking statements that are based on management’s beliefs and assumptions and on information currently available to management. All statements contained in this release other than statements of historical fact are forward-looking statements, including statements regarding our ability to develop, commercialize and achieve market acceptance of our current and planned products and services, our research and development efforts, and other matters regarding our business strategies, use of capital, results of operations and financial position, and plans and objectives for future operations.

In some cases, you can identify forward-looking statements by the words “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. These risks, uncertainties and other factors are described under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the documents we file with the Securities and Exchange Commission from time to time. We caution you that forward-looking statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. As a result, the forward-looking statements may not prove to be accurate. The forward-looking statements in this press release represent our views as of the date hereof. We undertake no obligation to update any forward-looking statements for any reason, except as required by law.

Published on : http://www.globenewswire.com/news-release/2021/02/23/2180066/0/en/RenalytixAI-to-announce-Financial-Results-for-six-and-three-months-ended-December-31-2020.html

NEW YORK, Feb. 04, 2021 (GLOBE NEWSWIRE) — Renalytix AI plc (LSE: RENX) (NASDAQ: RNLX), an artificial intelligence-enabled in vitro diagnostics company, focused on optimizing clinical management of kidney diseases to drive improved patient outcomes and advance value-based care, announced today that it will co-host a Capital Markets Day for Kidney Health with the American Society of Nephrology (ASN) on Thursday, February 11 from 8:00 a.m. — 12:30 p.m. EST. The virtual event will bring together a broad group of delegates representing the kidney community, including leading clinicians, representatives of U.S. government health agencies, kidney care innovators and investors focused on life sciences and medical technology, for a series of presentations and panel discussions on the challenges and innovations arising from kidney health and the market opportunity in this area.

The Capital Markets Day for Kidney Health event will feature keynote addresses by Susan E. Quaggin, MD, FRCP(C), FASN, President, American Society of Nephrology and Chief, Division of Nephrology and Hypertension, Director, Feingberg Cardiovascular and Renal Research Institute, Charles Horace Mayo Professor of Medicine at Northwestern University; and Steven Coca, DO, MS, Associate Professor of Medicine Icahn School of Medicine at Mount Sinai, New York and co-founder of RenalytixAI. RenalytixAI CEO James McCullough will also participate in a panel discussion on lead IPOs in kidney disease in 2020.

The full agenda and registration information can be viewed here: https://www.asn-online.org/KCMD

Kidney diseases affects 850 million individuals worldwide, including over 37 million Americans, costing the U.S. healthcare system over $120 billion per year in Medicare spending alone.^{1, 2, 3} Despite the significant patient need, awareness and new product development has lagged behind many other fields, until now. There is a trend among healthcare companies, medical providers, organizations, and researchers to assess early-stage prognosis and end-to-end integrated solutions for kidney disease in an effort to prevent the economic and health impacts.

“Better management in kidney disease is happening now, and the roster of speakers today are innovators in their field and at the cutting edge of transforming the way we understand the progression of early-to-end-stage kidney disease,” said Susan E. Quaggin, MD. “As we begin to change the consequences of kidney disease for patients through the use of emerging technologies, we expect to begin to see better outcomes for patients as well as benefits in the health system.”

“Kidney disease is one of the biggest unmet public health needs today. New advancements in precision medicine coupled with significant recent changes in reimbursement and regulatory policies have made kidney disease one of the most attractive areas for innovation and investment in the healthcare space,” said James McCullough, CEO of RenalytixAI.

The list of speakers participating in the Capital Markets Day for Kidney Health includes:

• Amy P. Abernathy, MD, PhD, US Food and Drug Administration
• Daniel Arias, Stifel Financial Corp.
• Randy Baron, Pinnacle Associates
• Sara Barrington, Verici DX Limited
• Steven G. Coca, DO, MS, Icahn School of Medicine at Mount Sinai, Co-Founder, RenalytixAI
• Jennifer Erickson, Former White House Office of Science and Technology Policy, Obama Administration
• Tod Ibrahim, American Society of Nephrology
• Alan S. Kliger, MD, Yale University School of Medicine
• Leslie Trigg, Outset Medical, Inc.
• Kevin Longino, National Kidney Foundation
• Rachel N. Meyer, American Society of Nephrology
• James McCullough, RenalytixAI
• Susan E. Quaggin, MD, FASN, American Society of Nephrology, Northwestern University
• Anne Rohall-Andrade, Living Kidney Donor, Former HHS Office of Assistant Secretary for Health, Trump Administration
• Prabir Roy-Chaudhury, MD, PhD, FRCP, University of North Carolina, Chapel Hill, American Society of Nephrology
• Jeffrey Shuren, MD, JD, US Food and Drug Administration
• Boris Vuchic, Crescent Rock Capital

This event is intended for investors only. Media interested in more information can contact [email protected].

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 1 out of 2 people with very low kidney function who are not on dialysis do not know they have CKD*. 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 the United States die while waiting for a kidney transplant.
* https://www.cdc.gov/kidneydisease/publications-resources/2019-national-facts.html

About the American Society of Nephrology
Since 1966, ASN has been leading the fight to prevent, treat, and cure kidney diseases throughout the world by educating health professionals and scientists, advancing research and innovation, communicating new knowledge, and advocating for the highest quality care for patients. ASN has more than 20,000 members representing 131 countries. For more information, please visit www.asn-online.org or contact the society at 202-640-4660.

About RenalytixAI
RenalytixAI (LSE: RENX) (NASDAQ: RNLX) 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. The Company’s lead product is KidneyIntelX.com (visit www.kidneyintelx.com) which is being designed to help make significant improvements in kidney disease prognosis, transplant management, clinical care, patient stratification for drug clinical trials, and drug target discovery. For more information, visit www.renalytixai.com

Sources
¹ American Society of Nephrology
² Centers for Disease Control and Prevention
³ United States Renal Data System

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 ability of technological and other advancements 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 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 28, 2020, 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.

Investor Contact:
Carrie Mendivil
[email protected]
415-937-5405

Media Contacts:
United States:
Jennifer Moritz
Zer0 to 5ive for RenalytixAI
(917) 748-4006
[email protected]

Outside of the United States:
Walbrook PR Limited
Paul McManus / Lianne Cawthorne
Tel: 020 7933 8780 or [email protected]
Mob: 07980 541 893 / 07584 391 303

Published on : http://www.globenewswire.com/news-release/2021/02/04/2169780/0/en/American-Society-of-Nephrology-and-Renalytix-to-Co-Host-Virtual-Capital-Markets-Day-for-Kidney-Health.html

NEW YORK, Jan. 13, 2021 (GLOBE NEWSWIRE) — The Centers for Medicaid & Medicare (CMS) announced the establishment of the Medicare Coverage of Innovative Technology (MCIT) pathway (RIN: 0938-AT88), to provide a coverage pathway for Medicare beneficiaries nationwide to have faster access to new, innovative medical devices and diagnostic tests designated under the Breakthrough Device review program and with market authorization by the U.S. Food and Drug Administration (FDA). Under MCIT, national Medicare coverage can become effective on the date of FDA approval or clearance of a breakthrough designated device and will continue for a period of four years. After a four-year period, continued coverage for Medicare beneficiaries will be based on one of three methods, 1) case-by-case coverage, 2) a local coverage determination, or 3) a national coverage determination.

“Having a clear path to national Medicare coverage for innovative products like KidneyIntelX provides a major catalyst to drive the robust research and clinical development programs necessary to address major unmet medical needs such as kidney disease,” stated Tom McLain, President, RenalytixAI. “MCIT will also encourage early engagement with FDA in developing new diagnostic tests and leverage the many benefits of Breakthrough Designation including priority review of needed technology. We appreciate the opportunity to work with FDA and CMS to tackle the critical issue of early stage prognosis to help slow or prevent kidney disease progression. This new coverage pathway will facilitate accelerated access to KidneyIntelX for Medicare beneficiaries and their primary care doctors to help assure a better quality of life and save lives.”

RenalytixAI’s lead product, KidneyIntelX, was granted FDA breakthrough designation in May 2019. After working closely with the FDA review team assigned to KidneyIntelX the company submitted its DeNovo 510K application for clearance in August 2020. Assuming FDA clearance is received in 2021, Renalytix will opt in for the automatic four-year National Medicare coverage period. In addition to the MCIT coverage pathway for the test, Renalytix has already designed a prospective utility and outcome study. The aim of the 2,000-patient study is to further demonstrate the clinical value of KidneyIntelX testing in delaying or preventing the progression of early-stage diabetic kidney disease.

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 1 out of 2 people with very low kidney function who are not on dialysis do not know they have CKD*. 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 the United States die while waiting for a kidney transplant.

* https://www.cdc.gov/kidneydisease/publications-resources/2019-national-facts.html

About RenalytixAI

RenalytixAI (NASDAQ:RNLX) 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. The Company’s lead product is KidneyIntelX.com (visit www.kidneyintelx.com) which is being designed to help make significant improvements in kidney disease prognosis, transplant management, clinical care, patient stratification for drug clinical trials, and drug target discovery. For more information, visit www.renalytixai.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 for KidneyIntelX to receive regulatory approval from the FDA, the commercial prospects of KidneyIntelX, if approved, including whether KidneyIntelX will be successfully distributed and marketed, our ability to take advantage of the MCIT program, 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 final prospectus filed with the SEC on July 17, 2020, 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.

Media Contacts:
United States:
Jennifer Moritz
Zer0 to 5ive for RenalytixAI
(917) 748-4006 Outside of the United States:
Walbrook PR Limited
Paul McManus / Lianne Cawthorne
Tel: 020 7933 8780 or 
Mob: 07980 541 893 / 07584 391 303

Published on : http://www.globenewswire.com/news-release/2021/01/13/2157588/0/en/Renalytix-Commends-HHS-CMS-on-Finalization-of-MCIT-Rule-to-Provide-National-Medicare-Coverage-for-FDA-Breakthrough-Devices-and-Diagnostics.html