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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) has announced plans to appoint Timothy Scannell as an independent non-executive director. Scannell, a seasoned leader with over 30 years of experience at Stryker, is expected to contribute to Renalytix's growth as it partners with hospital systems and expands the KidneyIntelX early-stage prognosis program. James McCullough, CEO of Renalytix, acknowledged the significance of Scannell's expertise at this crucial stage. The appointment awaits final terms and regulatory due diligence.
Renalytix plc (NASDAQ: RNLX) announced its participation in the BTIG MedTech, Digital Health, Life Science & Diagnostics Tools Conference set for February 15, 2022, at 3:30 p.m. EST. The event will feature a fireside chat, but it will not be webcast. Investors can register for virtual one-on-one meetings. Renalytix is a pioneer in bioprognosis for kidney health, with its key product, KidneyIntelX, receiving Breakthrough Designation from the FDA. This innovative solution aims to enhance kidney disease management and patient care.
Renalytix (NASDAQ: RNLX) announced positive results from the CANVAS study, demonstrating that KidneyIntelX effectively monitors patient responses to SGLT2 therapy in those with diabetes and chronic kidney disease (CKD). The study involved 1,325 participants and showed that KidneyIntelX can stratify risk and assess DKD progression over time. This study marks KidneyIntelX’s third peer-reviewed validation and highlights its role in precision medicine. The FDA previously granted KidneyIntelX Breakthrough Device designation, underscoring its potential to enhance kidney disease prognosis and management.
Renalytix (NASDAQ: RNLX) has formed a partnership with Singing River Health System to implement KidneyIntelX™ for managing kidney health in type 2 diabetes patients with early-stage chronic kidney disease. This deployment aims to improve health outcomes and cut costs in a region with high diabetes rates and significant healthcare disparities. Approximately 25% of Mississippi residents are Medicaid beneficiaries, with an estimated $3.4 billion annual cost associated with diabetes-related conditions. The partnership aligns with a broader commitment to address racial and economic disparities in healthcare.
Renalytix plc (NASDAQ: RNLX) announced the appointment of Jean M. Casner as Senior Vice President & Chief Human Resources Officer, effective January 3, 2022. Casner previously held similar roles at Cantel Medical, contributing to significant revenue growth. Her experience spans major firms including the NBA and Johnson & Johnson. She succeeds Trent Bingham, who left the company on December 31, 2021. CEO James McCullough emphasized the importance of her background for expanding human resources during Renalytix's growth phase, aiming for improved employee culture and operational support.
Renalytix plc (NASDAQ: RNLX) announces its participation in the 40th Annual J.P. Morgan Virtual Healthcare Conference, scheduled for January 12, 2022, at 2:15 p.m. EST. Interested investors can access the live and archived webcast on the company’s investors page. Renalytix is pioneering bioprognosis for kidney health, with its flagship product, KidneyIntelX, receiving FDA Breakthrough Designation aimed at improving kidney disease management and patient care. For more details, visit www.renalytix.com.
Renalytix (NASDAQ: RNLX) and the American Diabetes Association have launched a joint program aimed at enhancing kidney health for the 34 million Americans with type 2 diabetes. The initiative focuses on early detection and informed care to mitigate the progression of chronic kidney disease, which can affect up to 40% of individuals with diabetes by 2060. Experts will develop a comprehensive Diabetes Kidney Care Pathway, leveraging technology and clinical expertise to optimize care delivery and improve outcomes nationally.
Renalytix plc (NASDAQ: RNLX) reported Q1 2022 financial results, with revenue of $0.5 million, a significant increase compared to nil in Q1 2021. Operating expenses rose to $12.1 million, driven by higher R&D and administrative costs, resulting in a net loss of $10.1 million, up from $7.2 million year-over-year. Key business highlights include expanded market access for KidneyIntelX, growth in physician ordering, and new partnerships. Cash reserves remain strong at $54.3 million.
Renalytix plc (NASDAQ: RNLX) announced that it will release its first quarter fiscal year 2022 financial results on December 7, 2021, before market open. A conference call and webcast are scheduled for 8:30 a.m. EST to discuss these results, business strategy, partnerships, and regulatory processes. The company is a leader in bioprognosis for kidney health, with its product KidneyIntelX™ receiving Breakthrough Designation from the FDA, aimed at improving kidney disease management and prognosis.
Renalytix (NASDAQ: RNLX) held a panel discussion at the IDGA VA Healthcare Summit on October 27, 2021, focusing on early diagnosis and intervention of chronic kidney disease (CKD) in veterans with type 2 diabetes. This event coincided with the launch of KidneyIntelX within the Veterans Health Administration. Experts emphasized the significance of early risk assessment for kidney health and shared insights on using KidneyIntelX for personalized patient management. The product aims to improve long-term kidney health and reduce healthcare costs associated with kidney failure.
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