Current Trading and Outlook21 Jun 2024 23:07
We believe FDA authorization, positive utility and outcomes data, our physician and patient education programs, and comprehensive reimbursement puts us on a path towards kidneyintelX.dkd becoming broadly used across the United States among the 14 million Americans with diabetic kidney disease, and ultimately within the global market of 850 million people with chronic kidney disease. We are proud of the rapid pace of these achievements just five years from our company’s inception.
Our real-world evidence data is comprehensive and shows clear benefit. With FDA De Novo marketing authorization in June, kidneyintelX.dkd will become available commercially later in this financial year and we expect to see growth in adoption. The social need could not be higher to establish the innovative preventative medicine strategies that KidneylntelX technology enables at the front-end of diabetes and kidney disease.
During fiscal 2023 over 5,000 KidneylntelX tests were performed, which was up 55% from the prior year. We expect a meaningful increase in total tests during the remainder of fiscal 2024, building on quarterly test volumes of about 1,200 during fiscal 2023 and through first quarter of 2024. More than half of these during the first quarter of 2024 thus far are revenue generating, with a set of the Mount Sinai clinical trial tests no longer billable following last spring’s transition to full commercial payment at the hospital system. We are encouraged by the continued adoption by physicians beyond Mount Sinai. With the launch of the FDA-authorized kidneyintelX.dkd expected later this fiscal year, the enhancement of our direct to physician sales force, and new hospital partners such as Atrium / Wake Forest commencing commercial testing before year-end, we expect to see accelerating billable testing volume growth.