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