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Renalytix plc (NASDAQ: RNLX) is a pioneering company focused on the development of artificial intelligence (AI)-enabled clinical diagnostic solutions for kidney disease, one of the most widespread and costly chronic medical conditions worldwide. The company's flagship product, KidneyIntelX™, is designed to improve the diagnosis, prognosis, and clinical management of kidney diseases, particularly in patients with type II diabetes and those of African ancestry who are at risk of fast-progressing kidney disease. By leveraging advanced AI algorithms, KidneyIntelX aims to enhance patient stratification for drug clinical trials, facilitate drug target discovery, and ultimately reduce the estimated $114 billion annual cost of chronic and end-stage kidney disease to the U.S. healthcare system.
Renalytix plc has achieved significant milestones, including the commercial launch of KidneyIntelX as a laboratory-developed test in its CLIA-certified laboratory facilities. The company's diagnostic solutions are designed to be integrated into health systems and utilized by drug developers for better patient outcomes. Recently, KidneyIntelX received FDA De Novo authorization, marking a significant step towards widespread clinical adoption.
Recent Achievements:
- Inclusion of KidneyIntelX in clinical guidelines
- Issuance of a Medicare coverage draft
- Launch of a direct-to-physician sales force
- Release of new real-world outcomes evidence
- Significant year-over-year expense reductions
- Completion of equity financing
- Initiation of a strategic sale process
Renalytix plc has also formed strategic partnerships with prominent research institutions such as Mount Sinai, Wake Forest, and Joslin, to advance its research and development efforts. The company's financial strategy includes a plan to further reduce payroll expenses and total general and administrative costs while preserving its sales capacity.
With an unwavering commitment to innovation and patient care, Renalytix plc continues to lead the way in transforming kidney disease diagnosis and treatment, thereby creating substantial value for patients, healthcare providers, and investors alike.
Renalytix AI (NASDAQ: RNLX) reported groundbreaking findings from a study involving 1,325 participants with early-stage diabetic kidney disease (DKD) at the International Society of Nephrology World Congress of Nephrology 2021. The KidneyIntelX test successfully predicted DKD progression and demonstrated an 8-fold higher disease progression rate for high-risk patients compared to low-risk ones. Additionally, canagliflozin therapy displayed a 3-fold greater protective effect for high-risk patients. This data supports early intervention strategies, enhancing care decisions for DKD patients.
RenalytixAI has entered an exclusive option agreement with Joslin Diabetes Center to access novel biomarkers for kidney disease to enhance its KidneyIntelX platform. These biomarkers aim to improve early disease identification and therapeutic response understanding. Clinical validation studies are set to begin in the second half of 2021. RenalytixAI's ongoing collaboration with Joslin aims to leverage advanced research to enhance kidney disease management globally.
Renalytix AI shares findings from a 401 physician study presented at the National Kidney Foundation's 2021 Spring Clinical Meetings, emphasizing the utility of KidneyIntelX in assessing diabetic kidney disease risk. Results indicate that 98% of primary care physicians would order the test if reimbursement was secured, with significant increases in prescribing appropriate medications and referrals to specialists when utilizing KidneyIntelX. This data underscores the potential for better patient outcomes and reduced healthcare costs through early intervention.
RenalytixAI plc (NASDAQ: RNLX) announced significant findings regarding its KidneyIntelX™ platform, published in Diabetologia. The study, involving 1,146 type 2 diabetes patients, demonstrated that KidneyIntelX outperforms the standard care in predicting kidney function decline and kidney failure. It effectively segmented patients into high, intermediate, and low-risk categories, achieving a 69% positive predictive value for high-risk patients, compared to 40% from existing models. This advancement is expected to optimize clinical care and reduce costs associated with kidney disease.
Renalytix AI plc (NASDAQ: RNLX) has announced updates on the Medicare Coverage of Innovative Technology (MCIT) pathway, which will provide coverage for innovative medical devices and diagnostics. The Centers for Medicare & Medicaid Services (CMS) has delayed the MCIT rule's implementation by 60 days, initiating a 30-day comment period. RenalytixAI asserts that the MCIT rule will likely be effective during the FDA review of its product, KidneyIntelX, and that the delay will not materially impact its business plan.
Renalytix AI plc (NASDAQ: RNLX) announced the issuance of 17,652 ordinary shares under its Employee Share Purchase Plan (ESPP) to settle the purchase of 8,826 American Depositary Shares (ADSs) by employees. CFO O. James Sterling acquired 4,596 ordinary shares at £4.50 each ($12.563 per ADS). Following the issuance, the total number of ordinary shares will be 72,047,286, with each share carrying one vote. Admission of the new shares on the London Stock Exchange is expected on or around March 9, 2021.
Renalytix AI plc (NASDAQ: RNLX) reported its financial results for the quarter and six months ended December 31, 2020. The company recognized $0.4 million in pharmaceutical services revenue, with an operating loss of $8.9 million, compared to $4.7 million a year prior. Significant partnerships with DaVita and the University of Utah aim to enhance access to KidneyIntelX, while the recent finalization of the Medicare Coverage of Innovative Technology rule paves the way for broader insurance coverage. Cash reserves increased substantially to $74.5 million.
Renalytix AI (NASDAQ: RNLX) and the University of Utah have partnered to enhance kidney health management through the implementation of the KidneyIntelX diagnostic platform. This initiative aims to identify early-stage chronic kidney disease (CKD) patients and reduce kidney failure risks in large populations. The partnership includes integrating KidneyIntelX into electronic health records for over 1,700 clinicians, optimizing patient care through data-driven analytics and innovative care delivery models. Financial support will facilitate ongoing research and development in kidney disease treatment.
Renalytix AI plc (NASDAQ: RNLX) has announced the upcoming release of its financial results for the six and three months ended December 31, 2020, set for March 2, 2021. A conference call featuring CEO James McCullough and CFO O. James Sterling will take place at 8:30 a.m. EST to discuss these results and provide a corporate update. The company specializes in artificial intelligence-driven in vitro diagnostics for kidney disease, which affects over 850 million people worldwide, emphasizing the urgency of improved management in clinical settings.
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