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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) partners with St. Joseph's Health to implement an advanced clinical care model targeting early-stage diabetic kidney disease. The collaboration integrates KidneyIntelX™, a tool designed to assess the risk of kidney disease progression, with St. Joseph's healthcare management. This initiative aims to prevent unnecessary deterioration in diabetic patients, enhancing early intervention capabilities. St. Joseph's Health, part of Trinity Health, serves over 30 million people across 25 states, emphasizing value-based care and improved patient outcomes.
Renalytix plc (NASDAQ: RNLX) reported its results for the year ending June 30, 2021, highlighting significant advancements in regulatory approvals and partnerships. A U.S. government contract for KidneyIntelX™ testing at $950 per result covers over 140 agencies. The company secured positive coverage from 20 health insurers, including Blue Cross Blue Shield. Financially, it completed a dual listing on Nasdaq and raised $85.1 million in equity financing, with cash reserves of $65.1 million. Clinical validation was bolstered by peer-reviewed publications, showing KidneyIntelX effectively predicts kidney disease progression.
Renalytix plc (NASDAQ: RNLX) will release its financial results for Q4 and the full year of fiscal 2021 on October 21, 2021, prior to market opening. A conference call is scheduled for 8:30 a.m. EDT to discuss the financial outcomes, business strategy, and regulatory processes. The call can be accessed by participants in the U.S. and the U.K. via designated toll-free numbers. Renalytix focuses on advancing kidney health through innovative solutions, including the FDA-designated Breakthrough product, KidneyIntelX™.
Renalytix (NASDAQ: RNLX) has appointed Jed Fulk as Vice President of Sales, Government Accounts, to enhance its focus on early-stage kidney disease within the Veterans Health Administration. Fulk aims to build a team of 42 sales professionals to support the rollout of KidneyIntelX, designed to assist VA physicians in identifying diabetic kidney disease patients. The Veterans Health Administration serves approximately nine million veterans annually, with notable CKD and DKD prevalence. In April 2021, Renalytix secured a 10-year contract with the GSA for KidneyIntelX testing services.
Renalytix plc (NASDAQ: RNLX) and Mount Sinai Health System have expanded the KidneyIntelX risk assessment program for diabetic kidney disease. By Q4 2021, they anticipate a testing rate of 300 patients weekly, targeting around 6,000 patients by Q2 2022. Initial successes in Manhattan show effective early identification of patients at risk. The program integrates clinical workflows and aims to improve patient outcomes while potentially reducing healthcare costs. Renalytix acknowledges the financial interest Mount Sinai has in its operations.
Renalytix, trading under the ticker RNLX, announced its participation in the 2021 Wells Fargo Virtual Healthcare Conference scheduled for September 10 at 2:40 p.m. EDT. This event will feature a fireside chat with the company’s management, accessible via a live and archived webcast on their website. Renalytix is a leader in bioprognosis for kidney health and has developed the KidneyIntelX™ technology, recognized for its potential in chronic kidney disease diagnostics. For more details, visit renalytix.com.
Renalytix has announced the appointment of Daniel J. Levangie to its board of directors, effective August 30, 2021. Levangie, an experienced executive in the diagnostics and medical devices industry, previously held key positions at Exact Sciences, Insulet Corporation, and Dune Medical Devices. He will also serve on the remuneration committee. CEO James McCullough emphasized Levangie's role as critical to the implementation of their national marketing strategy for KidneyIntelX, aiming to reach over 200,000 primary care physicians and address the needs of 12 million diabetic kidney disease patients.
Renalytix Plc (NASDAQ: RNLX) announced a peer-reviewed publication showing that its KidneyIntelX testing solution could save healthcare systems $1.1 billion over five years for 100,000 type 2 diabetes patients with chronic kidney disease. The savings stem from better pharmacy management, specialist referrals, and reduced disease progression. The budget impact analysis (BIA) supports payer coverage, essential for market acceptance. The model was created with Boston Healthcare Associates to assess costs and benefits, highlighting the importance of early kidney disease prediction.
Renalytix plc (NASDAQ: RNLX) announced the appointment of Ann E. Berman to its board of directors, where she will chair the audit committee and join the nomination committee. Berman brings extensive experience from previous roles, including chief financial officer of Harvard University and board member of Loews Corporation. The company anticipates that her leadership will be influential as it aims to enhance shareholder value during a substantial growth phase, leveraging her expertise in financial strategy and compliance.
Renalytix (NASDAQ: RNLX) will present at the 41st Annual Canaccord Genuity Virtual Global Growth Conference on August 11, 2021, at 2:30 PM EDT. The presentation will be accessible via a live and archived webcast on the company's website in the investors section.
Renalytix focuses on developing AI-enabled clinical diagnostics for kidney disease, aiming to enhance diagnosis, clinical care, and drug discovery related to one of the most prevalent chronic health issues.
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