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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 Plc (NASDAQ: RNLX) appointed Joseph Hutson as Vice President of Quality and Regulatory to enhance its KidneyIntelX commercialization strategy. With over 23 years in life sciences and experience at Abbott and Becton Dickinson, Hutson will focus on ensuring compliance with regulatory standards, including FDA and IVDR. KidneyIntelX is currently under FDA review for De Novo marketing authorization as a Breakthrough Device. Renalytix aims to improve kidney disease diagnostics, addressing a significant public health issue affecting millions globally.
Renalytix (NASDAQ: RNLX) presents new study data indicating that KidneyIntelX effectively monitors kidney health in adults with type 2 diabetes. The international study involving 1,100 patients highlighted KidneyIntelX’s role in assessing therapeutic responses, particularly for those at high risk of kidney failure. This data will support collaborations for repeat testing and reimbursement, enhancing early risk stratification and treatment optimization in chronic kidney disease. The findings were shared at the American Diabetes Association event.
Renalytix AI plc (NASDAQ: RNLX) reported financial results for the quarter ended March 31, 2021, showing revenue of $0.6 million in services and $0.1 million in testing. The company announced partnerships with University of Utah and Atrium Health to improve kidney health. A significant 10-year contract with the U.S. General Services Administration was secured for KidneyIntelX testing at $950 per report. However, the net loss attributable to shareholders was $8.8 million, up from $0.7 million year-over-year, while cash reserves rose to $70.1 million.
Renalytix AI (NASDAQ: RNLX) announced a change of auditor to Ernst & Young LLP, effective May 12, 2021. The company will release its fiscal Q3 2021 financial results on June 15, 2021, prior to market opening, and will hold a conference call at 8:30 a.m. EDT to discuss the results. Notably, there were no disagreements with the previous auditor, Deloitte & Touche LLP, regarding accounting practices or auditing procedures. Renalytix AI focuses on artificial intelligence-enabled diagnostics for kidney disease management.
Renalytix AI (NASDAQ: RNLX) has announced key leadership hires to accelerate its commercialization strategy for the KidneyIntelX testing system, targeting early-stage diabetic kidney disease. The new team, experienced in sales, marketing, and healthcare partnerships, is poised to enhance adoption in the VA Medical Health System and expand into national markets. The company anticipates a broader roll-out in fiscal 2022, aligned with potential Medicare coverage. Kidney disease affects over 850 million globally, highlighting the urgency of Renalytix's solutions.
Renalytix AI plc (NASDAQ: RNLX) has released results from a utility study highlighting the significance of early-stage diabetic kidney disease (DKD) risk assessments. Conducted with 16 primary care physicians, the study found that 100% confirmed the necessity of accurate risk assessment to enhance patient management and adherence, which are crucial for preventing DKD progression. The KidneyIntelX platform demonstrated potential in predicting DKD progression, suggesting its adoption could improve outcomes and decrease healthcare costs.
Kantaro Biosciences, a joint venture involving RenalytixAI (RNLX) and the Mount Sinai Health System, has received Health Canada Authorization for its COVID-SeroKlir semi-quantitative antibody test kit. This kit can detect the presence and precise level of neutralizing IgG antibodies with 98.8% sensitivity and 99.6% specificity. Importantly, it is available for immediate use in Canadian laboratories without proprietary equipment. The test has already been deployed over 127,000 times on diverse populations, offering significant potential for guiding public health policies as Canada reopens.
Renalytix AI plc (NASDAQ: RNLX) partners with Atrium Health and Wake Forest School of Medicine to enhance kidney disease management. The partnership will utilize the KidneyIntelX platform for early-stage diabetic kidney disease risk assessment, integrated into Atrium's EHR system across 37 hospitals, serving over 7 million people. This initiative aims to reduce kidney disease progression and improve patient outcomes through data-driven insights. A multi-center program over five years promotes comprehensive care to enhance healthcare delivery and costs.
Renalytix AI has secured a 10-year contract from the U.S. Government to provide KidneyIntelX testing services across over 140 government departments and agencies. Effective April 15, 2021, this contract, valued at $950 per test, enhances access to early-stage kidney disease diagnostics. The contract aims to benefit veterans and active military personnel, offering crucial early detection of chronic kidney disease (CKD). Dr. James Post highlights its significance in managing CKD before nephrologist intervention. The contract supports Renalytix AI's market access strategy and broadens patient care delivery.
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