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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 that it will disclose its fourth quarter and full year fiscal 2022 financial results on October 31, 2022, prior to market opening. A conference call will follow at 8:30 a.m. ET to discuss the results and key business topics including strategy, partnerships, and regulatory processes. Renalytix is a leader in kidney health, with its product KidneyIntelX™ receiving Breakthrough Designation from the FDA, aimed at improving kidney disease prognosis.
Renalytix (NASDAQ: RNLX) announced the acceptance of four presentations at the American Society of Nephrology Kidney Week (November 3-6, 2022). These presentations include findings from a multi-year real world evidence study evaluating the KidneyIntelX™ platform's effectiveness in predicting kidney disease progression, emphasizing cost-effectiveness for the Medicare population. Notably, the platform shows a 72% improvement in risk assessments over standard metrics. The data highlights health equity issues, particularly in African American patients, and discusses potential healthcare savings.
Renalytix (NASDAQ: RNLX) announced the resignation of Ann Berman as a non-executive director and chair of the audit and nomination committees, effective immediately. Berman cited personal reasons for her departure but expressed confidence in the company's recent progress in reimbursement, regulatory, and commercial areas. Christopher Mills, the chairman, acknowledged Berman's valuable contributions and expressed regret over her resignation. The company will initiate a process to appoint a successor to her roles.
Renalytix plc (NASDAQ: RNLX) announced its participation in the H.C. Wainwright 24th Annual Global Investment Conference, scheduled for September 12-14, 2022. The company will hold a fireside chat, available for live and archived viewing starting at 7:00 a.m. Eastern Time on September 12, 2022, via the Company's website.
Renalytix, a leader in bioprognosis for kidney health, has developed the KidneyIntelX test to assess the risk of rapid kidney function decline in adults with Type 2 diabetes and early stages of chronic kidney disease.
Renalytix reported its financial results for the quarter ending March 31, 2022, showing a revenue of $0.8 million, up from $0.6 million in the same quarter the previous year. Operating expenses rose to $14.7 million, driven by increased headcount and research efforts. The net loss attributable to ordinary shareholders was $14.7 million, compared to $8.8 million a year prior. The company successfully raised $30 million in financing and aims to file a shelf registration statement for up to $300 million. KidneyIntelX testing continues to gain traction with over 3,000 risk scores generated.
Renalytix plc (NASDAQ: RNLX) will report its third quarter fiscal 2022 financial results on June 30, 2022, before market open. The company plans to hold a conference call at 8:30 a.m. ET to discuss these results and outline business strategy, partnerships, and regulatory matters. Interested participants can join via dial-in numbers or the provided webcast link. Renalytix is at the forefront of bioprognosis for kidney health, with its lead product, KidneyIntelX™, receiving Breakthrough Designation from the FDA.
KidneyIntelX testing by Renalytix has shown improved adherence to care guidelines among physicians treating patients with chronic kidney disease (CKD) at Mount Sinai Health System. The study involving 1,112 patients revealed a significant increase in the use of guideline-recommended therapies, including SGLT-2 inhibitors, and timely referrals to specialists. More than half of the tests were ordered by primary care physicians, facilitating early intervention and reducing disease progression risks. KidneyIntelX has received Breakthrough Device Designation from the FDA, underscoring its potential impact on kidney health management.
Renalytix (NASDAQ: RNLX) will present at the 42nd Annual William Blair Growth Stock Conference on June 9, 2022, at 2:00 p.m. CT. The presentation will be accessible via a live and archived webcast on the company’s website under the “Investors” section. Renalytix is a leader in bioprognosis for kidney health, focusing on risk assessment for kidney function decline in adults with type 2 diabetes. Their KidneyIntelX test aims to improve patient outcomes and streamline healthcare costs. More details are available on their official site.
Renalytix (NASDAQ: RNLX) announced positive outcomes from its KidneyIntelX™ test, showcased at the American Diabetes Association Scientific Sessions. The test successfully risk-stratified adults with type 2 diabetes and early-stage chronic kidney disease for serious clinical outcomes, including heart failure and mortality. Patients with elevated KidneyIntelX scores faced a three-fold increased risk of hospitalization for heart failure. This data enhances KidneyIntelX's role in guiding primary care physicians and enriching clinical trials for high-risk patients. The findings were published in Kidney360.
Renalytix (NASDAQ: RNLX) announced its participation in the American Diabetes Association (ADA) Scientific Sessions from June 3-7, 2022, showcasing the clinical utility of KidneyIntelX through two key presentations. The ePoster will present real-world data involving 1,112 patients with early-stage diabetic kidney disease, while an oral presentation will discuss KidneyIntelX's association with clinical outcomes in diabetic kidney disease. KidneyIntelX aims to enhance risk assessment for chronic kidney disease (CKD) in adults with type 2 diabetes, potentially improving patient outcomes and reducing healthcare costs.
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