Journey

NOVEMBER:

• Renalytix secures $29.1 million in funding to support the development and commercialization of two product categories for the early detection of kidney disease and accurate management of kidney transplant rejection

MARCH:

• Renalytix requests parallel CMS reimbursement review of KidneyIntelX with the FDA review
• Renalytix requests Breakthrough Device Designation of KidneyIntelX from the FDA

APRIL:

• Renalytix published manuscript outlining positive results that demonstrated the performance characteristics of our machine learning algorithm combining biomarkers and EHR data to predict fast progressing kidney disease

MAY:

• FDA grants Breakthrough Device Designation to Renalytix for its KidneyIntelX test, identifying it as a breakthrough technology for which no approved or cleared alternative exists and meeting the criteria of providing a more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease

JULY:

• Renalytix raises gross proceeds in follow-on financing on the AIM market, $17.3M
• Renalytix announces positive interim study results conducted with leading academic medical centers in the US

SEPTEMBER:

• Renalytix achieves inclusion on the Final 2020 Clinical Laboratory Fee Schedule (“CLFS”) with a set national price of $950 per reportable test for our KidneyIntelX test platform (effective January 2020 through December 2022).

OCTOBER:

• Renalytix obtains a distinct Common Procedural Terminology (CPT) reimbursement code 0105U, for its KidneyIntelX platform, effective across the U.S.

DECEMBER:

• Renalytix opens second CLIA-authorized testing facility, Utah

FEBRUARY:

• Renalytix receives ISO 13485 certification for its Salt Lake City Laboratory

MAY:

• Renalytix proposes dual-listing on NASDAQ

JUNE:

• Renalytix is granted a Clinical Laboratory Permit for KidneyIntelX from the NYS Department of Health, following an extensive review by a panel of Department of Health scientists and external reviewers of the analytical and clinical validation results
• Renalytix announces partnership with University of Michigan to extend its KidneyIntelX platform to an expanded population of CKD patients or patients at risk for developing CKD

JULY:

• Renalytix raises $85.1M on the NASDAQ Global Market in the U.S.
• Renalytix signs agreement to become a provider in the America’s Choice Provider Network, one of the largest, preferred networks in the US with members and providers in all 50 states and agreement with 1700+ payers

AUGUST:

• Renalytix announces partnership with Astra-Zeneca, teaming up to improve CKD treatments and outcomes
• Renalytix files submission with FDA, seeking clearance of its KidneyIntelX test platform
• Renalytix commences with a KidneyIntelX Multi-Center Study to monitor & predict kidney risk in COVID-19 patients

SEPTEMBER:

• Renalytix initiates KidneyIntelX Testing at Mount Sinai, with its first live EHR Integration

JANUARY:

• Renalytix signs multi-geography, U.S. partnership with DaVita, an end-to-end kidney solution

FEBRUARY:

• The University of Utah and Renalytix form partnership to enable health system-wide approach to help delay or prevent kidney disease progression in the earliest stages

APRIL:

• Multi-Center Study finds KidneyIntelX 72% more effective than the current standard of care in identifying early-stage patients at higher risk for disease progression and failure
• Clinical Utility Study demonstrates that primary care physicians highly likely to order KidneyIntelX to inform care decisions
• Renalytix and Joslin Diabetes Center enter exclusive option agreement for patent filings on select additional novel biomarkers in kidney disease for development and deployment in the KidneyIntelX platform
• KidneyIntelX demonstrates performance and informs treatment decisions in multinational CANagliflozin CardioVAScular Assessment Study (CANVAS)
• U.S. General Services Administration grants 10-year governmentwide contract for KidneyIntelX testing

MAY:

• Renalytix partners with Atrium Health, Wake Forest Baptist Health and Wake Forest School of Medicine to reduce impact of kidney disease in large populations

JUNE:

• Utility Study indicates KidneyIntelX risk assessment can address treatment ambiguity in primary care
• Renalytix announces new data demonstrating that KidneyIntelX can be effective at monitoring SGLT2 therapeutic response and improvements in kidney health over time in adults with Type 2 diabetes

JULY:

• Payer budget impact analysis projects significant savings from KidneyIntelX™ testing at primary care level, as published in peer-reviewed publication, Journal of Medical Economics.

SEPTEMBER:

• Mount Sinai initiates system-wide scaled-up implementation of KidneyIntelX™ early-stage risk assessment testing and care management program across primary care and specialty clinician networks under a real-world evidence development program for patients with diabetic kidney disease (DKD).

NOVEMBER:

• St. Joseph’s Health and Renalytix partner to advance value-based kidney health in New York. Partnership expands doctor and patient access to advanced prognosis and coordinated care management of early-stage diabetic kidney disease.

JANUARY:

• American Diabetes Association and Renalytix announce partnership and national program to establish early care management, technology innovation and large health system engagement to support the 34 million U.S. individuals living with diabetes.
• Singing River Health System and Renalytix join forces to improve kidney health on the Mississippi Gulf Coast, focusing on underserved populations with high disease burden.
• American Journal of Nephrology data demonstrates KidneyIntelX successfully monitors patient response to SGLT2 therapy in 1,325 CANagliflozin CardioVAScular Assessment Study (CANVAS) multinational clinical trial cohort patients.

FEBRUARY:

• KidneyIntelX™ clinical results presented at World Congress of Nephrology demonstrate improved prediction of kidney function over standard of care (UACR and historical eGFR change over time.

MARCH:

• Renalytix reaches enrollment milestone for building KidneyIntelX as premier precision medicine platform for kidney disease and diabetes. On track to reach over 30,000 biospecimens with matched electronic health records from multiple centers across the U.S.

JUNE:

• KidneyIntelX™ demonstrates ability to assess risk of heart failure hospitalization and death in large international diabetic kidney disease patient cohort. Data shared in oral presentation at American Diabetes Association 82^nd Scientific Sessions® highlights importance in early understanding of cardiovascular risk, a leading cause of death in patients with diabetes and chronic kidney disease.
• Late-breaking data presented at American Diabetes Association Scientific Sessions® demonstrates increased adherence to care guidelines for physicians using KidneyIntelX risk assessment to improve outcomes, alleviate patient suffering, and reduce significant financial burden associated with rapidly progressing chronic kidney disease.

AUGUST:

• Data results published in American Journal of Managed Care demonstrate adoption and clinical utility of KidneyIntelX™ with primary care physicians. Clinicians confirmed KidneyIntelX has value as a risk decision tool in their adult patients with type 2 diabetes and chronic kidney disease stages 1-3b.

OCTOBER:

• KidneyIntelX clinical utility and health economics validated in multiple data releases at American Society of Nephrologys. Four presentations, including first clinical utility findings from multi-year real world evidence results from a major healthcare system underscore value of KidneyIntelX™ platform in improving cost economics for Medicare population.

NOVEMBER:

• Published real world evidence demonstrates KidneyIntelX™ improved clinical decisions and outcomes in high-risk patients with early-stage diabetic kidney disease. Risk scoring by KidneyIntelX resulted in a 4.5-fold increase in new drug prescriptions (for SGLT2 inhibitors) for high risk compared to low risk patients, an observed reduction of HbA1c levels in the highest risk patients, an overall increased use of antihypertensive therapeutics, and an observed early reduction in albumin to creatine ratio levels in the low and intermediate risk groups.

DECEMBER:

• 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.